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Chemistry

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Also known as: 58-55-9, 1,3-dimethylxanthine, Elixophyllin, Theophyllin, Theophylline anhydrous, Theolair
Molecular Formula
C7H8N4O2
Molecular Weight
180.16  g/mol
InChI Key
ZFXYFBGIUFBOJW-UHFFFAOYSA-N
FDA UNII
0I55128JYK

Theophylline
A methyl xanthine derivative from tea with diuretic, smooth muscle relaxant, bronchial dilation, cardiac and central nervous system stimulant activities. Theophylline inhibits the 3',5'-CYCLIC NUCLEOTIDE PHOSPHODIESTERASE that degrades CYCLIC AMP thus potentiates the actions of agents that act through ADENYLYL CYCLASES and cyclic AMP.
Theophylline anhydrous is a Methylxanthine.
1 2D Structure

Theophylline

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
1,3-dimethyl-7H-purine-2,6-dione
2.1.2 InChI
InChI=1S/C7H8N4O2/c1-10-5-4(8-3-9-5)6(12)11(2)7(10)13/h3H,1-2H3,(H,8,9)
2.1.3 InChI Key
ZFXYFBGIUFBOJW-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CN1C2=C(C(=O)N(C1=O)C)NC=N2
2.2 Other Identifiers
2.2.1 UNII
0I55128JYK
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 1,3 Dimethylxanthine

2. 1,3-dimethylxanthine

3. 3,7-dihydro-1,3-dimethyl-1h-purine-2,6-dione

4. Accurbron

5. Aerobin

6. Aerolate

7. Afonilum Retard

8. Anhydrous, Theophylline

9. Aquaphyllin

10. Armophylline

11. Bronchoparat

12. Bronkodyl

13. Constant T

14. Constant-t

15. Constantt

16. Ct, Theo Von

17. Elixophyllin

18. Euphylong

19. Glycinate, Theophylline Sodium

20. Glycine Theophyllinate

21. Lodrane

22. Monospan

23. Nuelin

24. Nuelin S.a.

25. Quibron T Sr

26. Quibron T-sr

27. Quibron Tsr

28. Slo Phyllin

29. Slo-phyllin

30. Slophyllin

31. Sodium Glycinate, Theophylline

32. Somophyllin T

33. Somophyllin-t

34. Somophyllint

35. Sustaire

36. Synophylate

37. Theo 24

38. Theo Dur

39. Theo Von Ct

40. Theo-24

41. Theo-dur

42. Theo24

43. Theobid

44. Theocin

45. Theoconfin Continuous

46. Theodur

47. Theolair

48. Theolix

49. Theon

50. Theonite

51. Theopek

52. Theophyllinate, Glycine

53. Theophylline Anhydrous

54. Theophylline Sodium Glycinate

55. Theospan

56. Theostat

57. Theovent

58. Uniphyl

59. Uniphyllin

60. Uniphylline

61. Von Ct, Theo

2.3.2 Depositor-Supplied Synonyms

1. 58-55-9

2. 1,3-dimethylxanthine

3. Elixophyllin

4. Theophyllin

5. Theophylline Anhydrous

6. Theolair

7. Nuelin

8. Respbid

9. Theocin

10. Theo-dur

11. Elixophylline

12. Pseudotheophylline

13. Lanophyllin

14. Theovent

15. Uniphyl

16. Slo-phyllin

17. Accurbron

18. Armophylline

19. Bronkodyl

20. Doraphyllin

21. Liquophylline

22. Maphylline

23. Medaphyllin

24. Optiphyllin

25. Parkophyllin

26. Synophylate

27. Teofyllamin

28. Theacitin

29. Theocontin

30. Uniphyllin

31. Xantivent

32. Aerolate

33. Elixicon

34. Solosin

35. Teolair

36. Theobid

37. Theofol

38. Theograd

39. Theolix

40. Elixex

41. Acet-theocin

42. Slo-bid

43. Theophyl-225

44. Aerolate Iii

45. Duraphyl

46. Euphylong

47. Sustaire

48. Austyn

49. Somophyllin-t

50. Constant-t

51. Teofilina

52. Asmax

53. Quibron T/sr

54. Theal Tablets

55. Theophylline, Anhydrous

56. 1,3-dimethyl-7h-purine-2,6-dione

57. Somophyllin-df

58. Bronkodyl Sr

59. Theoclair-sr

60. Theoclear La

61. Spophyllin Retard

62. Choledyl Sa

63. Quibron-t

64. Theoclear 80

65. Theophyline

66. Theo-11

67. Theostat 80

68. Theochron

69. 3,7-dihydro-1,3-dimethyl-1h-purine-2,6-dione

70. Synophylate-l.a. Cenules

71. Theo-dur-sprinkle

72. Aquaphyllin

73. Tefamin

74. Theo-24

75. Theodel

76. Unifyl

77. Theona P

78. 1,3-dimethyl-3,7-dihydro-1h-purine-2,6-dione

79. Labid

80. Euphylline

81. Elixomin

82. Theolixir

83. Theophyl

84. Bronkotabs

85. Elixophyllin Sr

86. Theophylline-sr

87. Somophyllin-crt

88. Aerolate Sr

89. Theo-organidin

90. Theophyl-sr

91. Gs 2591a

92. Uni-dur

93. Theoclear-80

94. Quibron-t/sr

95. T-phyl

96. Theoclear-200

97. 1h-purine-2,6-dione, 3,7-dihydro-1,3-dimethyl-

98. Xanthine, 1,3-dimethyl-

99. Nsc 2066

100. X 115

101. Quadrinal

102. Theobid Jr.

103. Theoclear L.a.-130

104. Theal Tabl.

105. 1,3-dimethyl-1h-purine-2,6(3h,7h)-dione

106. 1,3-dimethyl-2,3,6,7-tetrahydro-1h-purine-2,6-dione

107. Theophylline Melting Point Standard

108. Nsc-2066

109. Purine-2,6(1h,3h)-dione, 1,3-dimethyl-

110. 1,3-dimethyl-1h-purine-2,6(3h,9h)-dione

111. Aerobin

112. Theodur

113. Theopek

114. Theospan

115. Doxophylline Metabolite M3

116. Chembl190

117. Mls000069390

118. 1,3-dimethylxanthine;theo-24

119. Diffumal

120. Chebi:28177

121. Lasma

122. 0i55128jyk

123. Pro-vent

124. 58-55-9 (anhydrous)

125. Nsc-757346

126. 1246816-25-0

127. Teofilina [polish]

128. Ncgc00018117-07

129. Ncgc00018117-17

130. Mudrane

131. Pulmidur

132. Smr000058537

133. Teonova

134. Theokin

135. Hylate

136. Dsstox_cid_1336

137. Nuelin Sa

138. Bronchodid Duracap

139. Dsstox_rid_76090

140. Uniphyllin Continus

141. Dsstox_gsid_21336

142. 1h-purine-2,6-dione, 3,9-dihydro-1,3-dimethyl-

143. Teocen 200

144. Elixophyllin(e)

145. Cas-58-55-9

146. Theolair (tn)

147. Elixophyllin (tn)

148. Uniphyl (tn)

149. Quibron-t (tn)

150. Theodur G (tn)

151. Ccris 4729

152. Hsdb 3399

153. Sr-01000075195

154. Einecs 200-385-7

155. Theo-24 (tn)

156. Telbans

157. Physpa

158. Unii-0i55128jyk

159. Ai3-50216

160. Unicontin Cr

161. 4eoh

162. Aescin-iia

163. 1,3-dimethyl-2,6-dioxo-1,2,3,6-tetrahydropurine

164. Mfcd00079619

165. Theophylline Form Ii

166. Theophylline,anhydrous

167. Theophylline Solu-tion

168. Component Of Primatene

169. Xanthine,3-dimethyl-

170. Opera_id_76

171. Spectrum_001038

172. Theophylline (jp17)

173. 2a3a

174. Prestwick0_000820

175. Prestwick0_000873

176. Prestwick1_000820

177. Prestwick1_000873

178. Prestwick2_000820

179. Prestwick2_000873

180. Prestwick3_000820

181. Prestwick3_000873

182. Spectrum2_000842

183. Spectrum3_000672

184. Spectrum4_000353

185. Spectrum5_001232

186. Theophylline [mi]

187. 8-(2-furyl)theophylline

188. Upcmld-dp123

189. Component Of Theo-organidin

190. Ec 200-385-7

191. Schembl4915

192. Theophylline Anhydrous,(s)

193. 1,3-dimethyl-1,3,7-trihydropurine-2,6-dione

194. Theophylline Anhydrous, Usp

195. Lopac0_000014

196. Bspbio_000719

197. Bspbio_000945

198. Bspbio_002363

199. Component Of Dicurin Procaine

200. Gtpl413

201. Kbiogr_000785

202. Kbioss_001518

203. Mls002152943

204. Mls002153487

205. Mls004491910

206. Mls006011970

207. Bidd:er0557

208. Bidd:gt0151

209. Divk1c_000203

210. Spectrum1500568

211. Theophylline [usp-rs]

212. Theophylline [who-dd]

213. Spbio_000823

214. Spbio_002640

215. Spbio_002866

216. Bpbio1_000791

217. Bpbio1_001041

218. Schembl8312163

219. Dimenhydrinate Impurity A

220. Component Of Tedral (salt/mix)

221. Dtxsid5021336

222. Upcmld-dp123:001

223. Bcbcmap01_000071

224. Bdbm10847

225. Bdbm82053

226. Component Of Quibron (salt/mix)

227. Hms500k05

228. Kbio1_000203

229. Kbio2_001518

230. Kbio2_004086

231. Kbio2_006654

232. Kbio3_001583

233. Nsc2066

234. Component Of Hecadrol (salt/mix)

235. Ninds_000203

236. Hms1921e03

237. Hms2089a06

238. Hms2092m05

239. Hms2233e16

240. Hms3259o06

241. Hms3369n14

242. Pharmakon1600-01500568

243. Component Of Primatene (salt/mix)

244. Bcp30664

245. Component Of Bronkotabs (salt/mix)

246. Hy-b0809

247. Str01537

248. Theophylline 1.0 Mg/ml In Methanol

249. Theophylline, >=99.0% (hplc)

250. Theophylline-[1,3-15n2,13c]

251. Tox21_110827

252. Tox21_202375

253. Tox21_300028

254. Ccg-20301

255. Nsc757346

256. Pdsp1_001018

257. Pdsp1_001234

258. Pdsp2_001002

259. Pdsp2_001218

260. Stk397040

261. Theophylline (1,3-dimethylxanthine)

262. Theophylline Anhydrous [hsdb]

263. Zinc18043251

264. Theophylline,anhydrous [vandf]

265. Akos000120961

266. Akos005434016

267. Component Of Quibron Plus (salt/mix)

268. Tox21_110827_1

269. Component Of Quibron-t/sr (salt/mix)

270. Component Of Theo-organdin (salt/mix)

271. Component Of Theolair Plus (salt/mix)

272. Cs-4158

273. Db00277

274. Nc00542

275. Purine-2,3h)-dione, 1,3-dimethyl-

276. Sdccgmls-0066620.p001

277. Sdccgsbi-0050003.p005

278. Theophylline-[1,3-15n2,2-13c]

279. Component Of Theo-organidin (salt/mix)

280. Idi1_000203

281. Smp1_000291

282. Component Of Slo-phyllin Gg (salt/mix)

283. Ncgc00018117-01

284. Ncgc00018117-02

285. Ncgc00018117-03

286. Ncgc00018117-04

287. Ncgc00018117-05

288. Ncgc00018117-06

289. Ncgc00018117-08

290. Ncgc00018117-09

291. Ncgc00018117-10

292. Ncgc00018117-11

293. Ncgc00018117-12

294. Ncgc00018117-13

295. Ncgc00018117-14

296. Ncgc00018117-15

297. Ncgc00018117-16

298. Ncgc00018117-18

299. Ncgc00018117-19

300. Ncgc00018117-20

301. Ncgc00018117-23

302. Ncgc00018117-37

303. Ncgc00022112-03

304. Ncgc00022112-04

305. Ncgc00022112-05

306. Ncgc00022112-07

307. Ncgc00022112-08

308. Ncgc00022112-09

309. Ncgc00022112-10

310. Ncgc00022112-11

311. Ncgc00022112-12

312. Ncgc00254040-01

313. Ncgc00259924-01

314. Wln: T56 Bm Dn Fnvnvj F1 H1

315. Ac-20328

316. Component Of Dicurin Procaine (salt/mix)

317. Nci60_001736

318. Smr003435989

319. Theophylline, Anhydrous, >=99%, Powder

320. Component Of Primatene Tablets (salt/mix)

321. Purine,6(1h,3h)-dione, 1,3-dimethyl-

322. Sbi-0050003.p004

323. Component Of Mudrane Gg Elixir (salt/mix)

324. Db-053224

325. Theophylline 100 Microg/ml In Acetonitrile

326. 1h-purine-2, 3,7-dihydro-1,3-dimethyl-

327. Ab00052106

328. Ft-0631259

329. Ft-0675140

330. N1442

331. T0179

332. C07130

333. D00371

334. D85002

335. Dimenhydrinate Impurity A [ep Impurity]

336. Pentoxifylline Impurity C [ep Impurity]

337. Ab00052106-20

338. Ab00052106-22

339. Ab00052106-23

340. Ab00052106_24

341. Ab00052106_25

342. Ab00052106_26

343. 1,3-dimethyl-3,9-dihydro-1h-purine-2,6-dione

344. A900445

345. L000595

346. Q407308

347. 1,3-dimethyl-3,7-dihydro-1h-purine-2,6-dione #

348. Q-201819

349. Sr-01000075195-1

350. Sr-01000075195-3

351. Sr-01000075195-5

352. 1,3-dimethyl-6-hydroxy-1,3-dihydro-2h-purin-2-one

353. Brd-k97799481-001-02-0

354. Brd-k97799481-001-12-9

355. Brd-k97799481-002-03-6

356. 1h-purine-2,6-dione, 3,7-dihydro-1,3-dimethyl-, Mo

357. F2173-0145

358. Z271004650

359. A3133d49-aab6-49a1-b60b-b5198f327d3f

360. Theophylline, British Pharmacopoeia (bp) Reference Standard

361. Theophylline, European Pharmacopoeia (ep) Reference Standard

362. (8alpha, 9s)-10,11-dihydro-6'-methoxycinchonan-9-amine Trihydrochloride, Min. 90%

363. Theophylline Melting Point Standard, United States Pharmacopeia (usp) Reference Standard

364. Theophylline Solution, 1.0 Mg/ml In Methanol, Ampule Of 1 Ml, Certified Reference Material

365. Theophylline, Pharmaceutical Secondary Standard; Certified Reference Material

366. 50857-74-4

367. 75448-53-2

368. Theo-24;1,3-dimethyl-3,7-dihydro-1h-purine-2,6-dione ;1,3-dimethylxanthine;1,3-dimethyl-xanthin

369. Theophylline Melting Point Standard, Pharmaceutical Secondary Standard; Certified Reference Material

370. Theophylline, Certified Reference Material, United States Pharmacopeia (usp) Reference Standard

2.4 Create Date
2004-09-16
3 Chemical and Physical Properties
Molecular Weight 180.16 g/mol
Molecular Formula C7H8N4O2
XLogP30
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count3
Rotatable Bond Count0
Exact Mass180.06472551 g/mol
Monoisotopic Mass180.06472551 g/mol
Topological Polar Surface Area69.3 Ų
Heavy Atom Count13
Formal Charge0
Complexity267
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Information
1 of 14  
Drug NameCholedyl sa
PubMed HealthTheophylline
Drug ClassesBronchodilator, Methylxanthine
Drug LabelTheophylline is structurally classified as a methylxanthine. It occurs as a white, odorless, crystalline powder with a bitter taste. Anhydrous theophylline has the chemical name 1H-Purine- 2,6-dione, 3,7-dihydro-1,3 -dimethyl-, and is represented by...
Active IngredientOxtriphylline
Dosage FormTablet, extended release
RouteOral
Strength600mg; 400mg
Market StatusPrescription
CompanyWarner Chilcott

2 of 14  
Drug NameElixophyllin
PubMed HealthTheophylline
Drug ClassesBronchodilator, Methylxanthine
Active IngredientTheophylline
Dosage FormSolution, elixir
RouteOral
Strength80mg/15ml
Market StatusPrescription
CompanySun Pharm Inds

3 of 14  
Drug NameTheo-24
PubMed HealthTheophylline
Drug ClassesBronchodilator, Methylxanthine
Drug LabelTheophylline is structurally classified as a methylxanthine. It occurs as a white, odorless, crystalline powder with a bitter taste. Anhydrous theophylline has the chemical name 1H-Purine-2,6-dione, 3,7-dihydro-1,3-dimethyl-, and is represented by th...
Active IngredientTheophylline
Dosage FormCapsule, extended release
RouteOral
Strength200mg; 400mg; 300mg; 100mg
Market StatusPrescription
CompanyActient Pharms

4 of 14  
Drug NameTheochron
Drug LabelTheophylline is structurally classified as a methylxanthine. It occurs as a white, odorless, crystalline powder with a bitter taste. Anhydrous theophylline has the chemical name 1H-Purine-2,6-dione,3,7-dihydro-1,3-dimethyl-, and is represented by the...
Active IngredientTheophylline
Dosage FormTablet, extended release
RouteOral
Strength200mg; 100mg
Market StatusPrescription
CompanySun Pharm Inds

5 of 14  
Drug NameTheolair
Drug LabelUniphyl (theophylline, anhydrous) Tablets in a controlled-release system allows a 24-hour dosing interval for appropriate patients.Theophylline is structurally classified as a methylxanthine. It occurs as a white, odorless, crystalline powder with...
Active IngredientTheophylline
Dosage FormTablet
RouteOral
Strength250mg; 125mg
Market StatusPrescription
CompanyMedicis

6 of 14  
Drug NameTheophylline
Active IngredientTheophylline
Dosage FormTablet, extended release; Solution
Routeoral; Oral
Strength200mg; 80mg/15ml; 600mg; 400mg; 300mg; 100mg; 450mg
Market StatusPrescription
CompanySilarx; Alembic; Nostrum; Rhodes Pharms; Glenmark Generics; Teva Pharms; Pliva; Tris Pharma

7 of 14  
Drug NameUniphyl
Active IngredientTheophylline
Dosage FormTablet, extended release
RouteOral
Strength400mg
Market StatusPrescription
CompanyRhodes Pharms

8 of 14  
Drug NameCholedyl sa
PubMed HealthTheophylline
Drug ClassesBronchodilator, Methylxanthine
Drug LabelTheophylline is structurally classified as a methylxanthine. It occurs as a white, odorless, crystalline powder with a bitter taste. Anhydrous theophylline has the chemical name 1H-Purine- 2,6-dione, 3,7-dihydro-1,3 -dimethyl-, and is represented by...
Active IngredientOxtriphylline
Dosage FormTablet, extended release
RouteOral
Strength600mg; 400mg
Market StatusPrescription
CompanyWarner Chilcott

9 of 14  
Drug NameElixophyllin
PubMed HealthTheophylline
Drug ClassesBronchodilator, Methylxanthine
Active IngredientTheophylline
Dosage FormSolution, elixir
RouteOral
Strength80mg/15ml
Market StatusPrescription
CompanySun Pharm Inds

10 of 14  
Drug NameTheo-24
PubMed HealthTheophylline
Drug ClassesBronchodilator, Methylxanthine
Drug LabelTheophylline is structurally classified as a methylxanthine. It occurs as a white, odorless, crystalline powder with a bitter taste. Anhydrous theophylline has the chemical name 1H-Purine-2,6-dione, 3,7-dihydro-1,3-dimethyl-, and is represented by th...
Active IngredientTheophylline
Dosage FormCapsule, extended release
RouteOral
Strength200mg; 400mg; 300mg; 100mg
Market StatusPrescription
CompanyActient Pharms

11 of 14  
Drug NameTheochron
Drug LabelTheophylline is structurally classified as a methylxanthine. It occurs as a white, odorless, crystalline powder with a bitter taste. Anhydrous theophylline has the chemical name 1H-Purine-2,6-dione,3,7-dihydro-1,3-dimethyl-, and is represented by the...
Active IngredientTheophylline
Dosage FormTablet, extended release
RouteOral
Strength200mg; 100mg
Market StatusPrescription
CompanySun Pharm Inds

12 of 14  
Drug NameTheolair
Drug LabelUniphyl (theophylline, anhydrous) Tablets in a controlled-release system allows a 24-hour dosing interval for appropriate patients.Theophylline is structurally classified as a methylxanthine. It occurs as a white, odorless, crystalline powder with...
Active IngredientTheophylline
Dosage FormTablet
RouteOral
Strength250mg; 125mg
Market StatusPrescription
CompanyMedicis

13 of 14  
Drug NameTheophylline
Active IngredientTheophylline
Dosage FormTablet, extended release; Solution
Routeoral; Oral
Strength200mg; 80mg/15ml; 600mg; 400mg; 300mg; 100mg; 450mg
Market StatusPrescription
CompanySilarx; Alembic; Nostrum; Rhodes Pharms; Glenmark Generics; Teva Pharms; Pliva; Tris Pharma

14 of 14  
Drug NameUniphyl
Active IngredientTheophylline
Dosage FormTablet, extended release
RouteOral
Strength400mg
Market StatusPrescription
CompanyRhodes Pharms

4.2 Therapeutic Uses

Bronchodilator Agents; Phosphodiesterase Inhibitors; Purinergic P1 Receptor Antagonists; Vasodilator Agents

National Library of Medicine's Medical Subject Headings. Theophylline. Online file (MeSH, 2016). Available from, as of June 24, 2016: https://www.nlm.nih.gov/mesh/2016/mesh_browser/MBrowser.html


/CLINICAL TRIALS/ ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. The Web site is maintained by the National Library of Medicine (NLM) and the National Institutes of Health (NIH). Each ClinicalTrials.gov record presents summary information about a study protocol and includes the following: Disease or condition; Intervention (for example, the medical product, behavior, or procedure being studied); Title, description, and design of the study; Requirements for participation (eligibility criteria); Locations where the study is being conducted; Contact information for the study locations; and Links to relevant information on other health Web sites, such as NLM's MedlinePlus for patient health information and PubMed for citations and abstracts for scholarly articles in the field of medicine. Theophylline is included in the database.

NIH/NLM; ClinicalTrials.Gov. Available from, as of July 6, 2016: https://clinicaltrials.gov/search/intervention=theophylline


Limited evidence suggests that an IV xanthine derivative (e.g., theophylline, aminophylline) could be beneficial as add-on therapy in children who are admitted to an intensive care unit (ICU) for severe exacerbations of asthma not controlled by inhaled and IV beta2-adrenergic agonists, ipratropium bromide, and IV corticosteroids; however, the efficacy of such add-on IV theophylline therapy has not been established in adults.

American Society of Health-System Pharmacists 2016; Drug Information 2016. Bethesda, MD. 2016, p. 3602


Theophylline is indicated for the treatment of the symptoms and reversible airflow obstruction associated with chronic asthma and other chronic lung diseases, e.g., emphysema and chronic bronchitis. /Included in US product labeling/

NIH; DailyMed. Current Medication Information for Theophylline (Anhydrous) Tablet, Extended Release (Updated: November 2014). Available from, as of July 21, 2016: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=038c2b07-8028-4dc4-847c-adafe1b0e81a


For more Therapeutic Uses (Complete) data for THEOPHYLLINE (10 total), please visit the HSDB record page.


4.3 Drug Warning

When administered rectally as suppositories (dosage form no longer commercially available in the US), theophyllines have caused rectal irritation and inflammation. /Theophyllines/

American Society of Health-System Pharmacists 2016; Drug Information 2016. Bethesda, MD. 2016, p. 3605


Theophyllines may also produce transiently increased urinary frequency, dehydration, twitching of fingers and hands, tachypnea, and elevated serum AST (SGOT) concentrations. Hypersensitivity reactions characterized by urticaria, generalized pruritus, and angioedema have been reported with aminophylline administration. A contact-type dermatitis, caused by hypersensitivity to the ethylenediamine component of aminophylline, has also been reported. Bone marrow suppression, leukopenia, thrombocytopenia, and hemorrhagic diathesis have also been reported, but their association with theophylline therapy is questionable. Other adverse effects of theophyllines include albuminuria, increased urinary excretion of renal tubular cells and erythrocytes, hyperglycemia, and syndrome of inappropriate secretion of antidiuretic hormone (SIADH). /Theophyllines/

American Society of Health-System Pharmacists 2016; Drug Information 2016. Bethesda, MD. 2016, p. 3605


Adverse cardiovascular effects of theophyllines include palpitation, sinus tachycardia, extrasystoles, and increased pulse rate. These adverse cardiovascular effects are usually mild and transient. Flushing, hypotension, circulatory failure, and ventricular arrhythmias may also occur. /Theophyllines/

American Society of Health-System Pharmacists 2016; Drug Information 2016. Bethesda, MD. 2016, p. 3605


Theophyllines produce GI irritation and CNS stimulation following administration by any route. Theophyllines are all somewhat irritating to gastric mucosa; the importance of reported differences among the individual agents is doubtful. The most common adverse GI effects (both locally and centrally mediated) include nausea, vomiting, epigastric pain, abdominal cramps, anorexia, and, rarely, diarrhea. Hematemesis has also occurred. Adverse CNS effects, which are often more severe in children than in adults, include headache, irritability, restlessness, nervousness, insomnia, dizziness, reflex hyperexcitability, and seizures. Reduction of theophylline dosage usually reduces the incidence and severity of adverse gastric and CNS effects; however, if these adverse effects persist, the drug may have to be withdrawn. The drugs may be administered orally before or after meals, with a full glass of liquid, or with antacids to minimize locally mediated GI irritation. /Theophyllines/

American Society of Health-System Pharmacists 2016; Drug Information 2016. Bethesda, MD. 2016, p. 3605


For more Drug Warnings (Complete) data for THEOPHYLLINE (19 total), please visit the HSDB record page.


4.4 Drug Indication

For the treatment of the symptoms and reversible airflow obstruction associated with chronic asthma and other chronic lung diseases, such as emphysema and chronic bronchitis.


FDA Label


5 Pharmacology and Biochemistry
5.1 Pharmacology

Theophylline, an xanthine derivative chemically similar to caffeine and theobromine, is used to treat asthma and bronchospasm. Theophylline has two distinct actions in the airways of patients with reversible (asthmatic) obstruction; smooth muscle relaxation (i.e., bronchodilation) and suppression of the response of the airways to stimuli (i.e., non-bronchodilator prophylactic effects).


5.2 MeSH Pharmacological Classification

Vasodilator Agents

Drugs used to cause dilation of the blood vessels. (See all compounds classified as Vasodilator Agents.)


Bronchodilator Agents

Agents that cause an increase in the expansion of a bronchus or bronchial tubes. (See all compounds classified as Bronchodilator Agents.)


Phosphodiesterase Inhibitors

Compounds which inhibit or antagonize the biosynthesis or actions of phosphodiesterases. (See all compounds classified as Phosphodiesterase Inhibitors.)


Purinergic P1 Receptor Antagonists

Compounds that bind to and block the stimulation of PURINERGIC P1 RECEPTORS. (See all compounds classified as Purinergic P1 Receptor Antagonists.)


5.3 FDA Pharmacological Classification
5.3.1 Active Moiety
THEOPHYLLINE ANHYDROUS
5.3.2 FDA UNII
0I55128JYK
5.3.3 Pharmacological Classes
Xanthines [CS]; Methylxanthine [EPC]
5.4 ATC Code

R03DA04

S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355


R - Respiratory system

R03 - Drugs for obstructive airway diseases

R03D - Other systemic drugs for obstructive airway diseases

R03DA - Xanthines

R03DA04 - Theophylline


5.5 Absorption, Distribution and Excretion

Absorption

Theophylline is rapidly and completely absorbed after oral administration in solution or immediate-release solid oral dosage form.


Route of Elimination

Theophylline does not undergo any appreciable pre-systemic elimination, distributes freely into fat-free tissues and is extensively metabolized in the liver. Renal excretion of unchanged theophylline in neonates amounts to about 50% of the dose, compared to about 10% in children older than three months and in adults.


Volume of Distribution

0.3 to 0.7 L/kg


Clearance

0.29 mL/kg/min [Premature neonates, postnatal age 3-15 days]

0.64 mL/kg/min [Premature neonates, postnatal age 25-57 days]

1.7 mL/kg/min [Children 1-4 years]

1.6 mL/kg/min [Children 4-12 years]

0.9 mL/kg/min [Children 13-15 years]

1.4 mL/kg/min [Children 16-17 years]

0.65 mL/kg/min [Adults (16-60 years), otherwise healthy non-smoking asthmatics]

0.41 mL/kg/min [Elderly (>60 years), non-smokers with normal cardiac, liver, and renal function]

0.33 mL/kg/min [Acute pulmonary edema]

0.54 mL/kg/min [COPD >60 years, stable, non-smoker >1 year]

0.48 mL/kg/min [COPD with cor pulmonale]

1.25 mL/kg/min [Cystic fibrosis (14-28 years)]

0.31 mL/kg/min [Liver disease cirrhosis]

0.35 mL/kg/min [acute hepatitis]

0.65 mL/kg/min [cholestasis]

0.47 mL/kg/min [Sepsis with multi-organ failure]

0.38 mL/kg/min [hypothyroid]

0.8 mL/kg/min [hyperthyroid]


When administered IM, theophylline is usually absorbed slowly and incompletely. Rectal suppositories (no longer commercially available in the US) are slowly and erratically absorbed, regardless of whether the suppository base is hydrophilic or lipophilic.

American Society of Health-System Pharmacists 2016; Drug Information 2016. Bethesda, MD. 2016, p. 3607


In neonates, approximately 50% of the theophylline dose is excreted unchanged in the urine. Beyond the first three months of life, approximately 10% of the theophylline dose is excreted unchanged in the urine.

NIH; DailyMed. Current Medication Information for Theophylline (Anhydrous) Tablet, Extended Release (Updated: November 2014). Available from, as of July 21, 2016: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=038c2b07-8028-4dc4-847c-adafe1b0e81a


Dissolution appears to be the rate-limiting step in the absorption of oral theophylline. Under the acidic conditions of the stomach, the theophylline salts and compounds release free theophylline. ... Microcrystalline dosage forms and oral solutions of theophyllines are absorbed more rapidly, but not to a greater extent, than are uncoated tablets. Although the rate of absorption is slower, extended-release preparations (capsules and tablets) of theophylline are generally absorbed to the same extent as uncoated tablets; however, the actual rate of absorption of extended-release preparations may differ. Extended-release preparations of theophyllines have been formulated to release the drug at various rates suitable for dosing every 8-12, 12, or 24 hours; however, the actual dosing frequency for a given patient depends on their individual pharmacokinetic parameters. Since the rate and extent of absorption may differ between various extended-release preparations and sometimes between different dosage sizes of the same preparation, patients should generally be stabilized on a given preparation; substitution of one extended-release preparation for another should generally only be made when the preparations have been shown to be equivalent and/or the patient is evaluated pharmacokinetically during the transition period. Absorption of theophyllines may also be delayed, but is generally not reduced, by the presence of food in the GI tract; however, the effect of food on the absorption of extended-release preparations appears to be variable, and the manufacturer's recommendations for administration of specific preparations should be followed.

American Society of Health-System Pharmacists 2016; Drug Information 2016. Bethesda, MD. 2016, p. 3607


IV theophylline produces the highest and most rapid serum theophylline concentration. ... Slightly lower or equal peak serum concentrations are reached after oral administration of equal amounts of theophylline in uncoated tablet, capsule, or liquid formulations. Following oral administration of theophylline capsules or uncoated tablets, peak serum concentrations are usually reached in 1-2 hours. Peak serum theophylline concentrations are usually obtained after about 1 hour when theophylline oral solutions or microcrystalline tablets are administered. Enteric-coated theophylline tablets produce variable serum concentrations which usually peak at about 5 hours. Single doses of extended-release theophylline capsules or tablets usually produce peak serum concentrations after 4 hours, but commercial products vary in their rates and completeness of absorption. Extended-release theophylline preparations are generally associated with relatively small fluctuations in steady-state peak and trough serum concentration; however, clinically important steady-state peak-trough differences may occur in individuals who rapidly eliminate theophylline. Theophylline retention enemas usually produce peak serum concentrations in 1-2 hours. Serum theophylline concentrations generally have been apparent 3-5 hours after administration of the drug as rectal suppositories (no longer commercially available in the US).

American Society of Health-System Pharmacists 2016; Drug Information 2016. Bethesda, MD. 2016, p. 3607


For more Absorption, Distribution and Excretion (Complete) data for THEOPHYLLINE (19 total), please visit the HSDB record page.


5.6 Metabolism/Metabolites

Hepatic. Biotransformation takes place through demethylation to 1-methylxanthine and 3-methylxanthine and hydroxylation to 1,3-dimethyluric acid. 1-methylxanthine is further hydroxylated, by xanthine oxidase, to 1-methyluric acid. About 6% of a theophylline dose is N-methylated to caffeine. Caffeine and 3-methylxanthine are the only theophylline metabolites with pharmacologic activity.


Both the N-demethylation and hydroxylation pathways of theophylline biotransformation are capacity-limited. Due to the wide intersubject variability of the rate of theophylline metabolism, non-linearity of elimination may begin in some patients at serum theophylline concentrations <10 ug/mL. Since this non-linearity results in more than proportional changes in serum theophylline concentrations with changes in dose, it is advisable to make increases or decreases in dose in small increments in order to achieve desired changes in serum theophylline concentrations. Accurate prediction of dose-dependency of theophylline metabolism in patients a priori is not possible, but patients with very high initial clearance rates (i.e., low steady-state serum theophylline concentrations at above average doses) have the greatest likelihood of experiencing large changes in serum theophylline concentration in response to dosage changes.

NIH; DailyMed. Current Medication Information for Theophylline (Anhydrous) Tablet, Extended Release (Updated: November 2014). Available from, as of July 21, 2016: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=038c2b07-8028-4dc4-847c-adafe1b0e81a


Caffeine and 3-methylxanthine are the only theophylline metabolites with pharmacologic activity. 3-methylxanthine has approximately one tenth the pharmacologic activity of theophylline and serum concentrations in adults with normal renal function are <1 ug/mL. In patients with end-stage renal disease, 3-methylxanthine may accumulate to concentrations that approximate the unmetabolized theophylline concentration. Caffeine concentrations are usually undetectable in adults regardless of renal function. In neonates, caffeine may accumulate to concentrations that approximate the unmetabolized theophylline concentration and thus, exert a pharmacologic effect.

NIH; DailyMed. Current Medication Information for Theophylline (Anhydrous) Tablet, Extended Release (Updated: November 2014). Available from, as of July 21, 2016: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=038c2b07-8028-4dc4-847c-adafe1b0e81a


Theophylline is metabolized by the liver to 1,3-dimethyluric acid, 1-methyluric acid, and 3-methylxanthine. ... Individuals metabolize theophylline at different rates; however, individual metabolism of the drug is generally reproducible. Theophylline and its metabolites are excreted mainly by the kidneys. Renal clearance of the drug, however, contributes only 8-12% of the overall plasma clearance of theophylline. Small amounts of theophylline are excreted in feces unchanged.

American Society of Health-System Pharmacists 2016; Drug Information 2016. Bethesda, MD. 2016, p. 3607


Unchanged theophylline (35% of urinary radioactivity) and 1,3-dimethyluric acid (34%) are the main compounds excreted in urine, followed by 1-methyluric acid (18%), 3-methylxanthine (3%) and unidentified polar metabolites (4.8%). Theophylline metabolism was impaired in rats at day 18 of gestation, as shown by increased excretion of theophylline (73%); this was explained by a decreased formation of 1,3-dimethyluric acid (-68%) and 1-methyluric acid (-30%). Essentially similar results were obtained with pregnant baboons. Each animal species is characterized by differences in the profile of the metabolites recovered in urine; in addition, quantitative differences in theophylline metabolic pathways were seen even in different strains of mice.

IARC. Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Humans. Geneva: World Health Organization, International Agency for Research on Cancer, 1972-PRESENT. (Multivolume work). Available at: https://monographs.iarc.fr/ENG/Classification/index.php, p. V51 397 (1991)


For more Metabolism/Metabolites (Complete) data for THEOPHYLLINE (7 total), please visit the HSDB record page.


Theophylline has known human metabolites that include 1,3-Dimethyluric acid, 1-Methylxanthine, and 3-Methylxanthine.

Theophylline is a known human metabolite of caffeine.

S73 | METXBIODB | Metabolite Reaction Database from BioTransformer | DOI:10.5281/zenodo.4056560


5.7 Biological Half-Life

8 hours


In maintenance-dose theophylline schedules, serum concentrations among patients vary at least sixfold and serum half-lives exhibit wide interpatient variation because of differences in rate of metabolism. Serum half lives ranges from about 3-12.8 (average 7-9) hours in otherwise healthy, nonsmoking asthmatic adults, from about 1.5-9.5 hours in children, and from about 15-58 hours in premature infants. ... When compared with that of otherwise healthy, nonsmoking asthmatic adults, the serum half life of theophylline may be increased and total body clearance decreased in patients with congestive heart failure, chronic obstructive pulmonary disease, cor pulmonale, or liver disease, and in geriatric patients. In cigarette and/or marijuana smokers, theophylline serum half life averages 4-5 hours and total body clearance is increased compared with nonsmokers.

American Society of Health-System Pharmacists 2016; Drug Information 2016. Bethesda, MD. 2016, p. 3607


Theophylline is distributed rapidly within the body, and plasma half-times were 5.7-11.5 hr in dogs, 11 hr in pigs, 7.8 hr in cats, 3.8-5.5 hr in rabbits and 1.2-4 hr in rats. At higher doses, rats had longer half-times probably because of a combination of increased diuresis and saturation of the metabolism.

IARC. Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Humans. Geneva: World Health Organization, International Agency for Research on Cancer, 1972-PRESENT. (Multivolume work). Available at: https://monographs.iarc.fr/ENG/Classification/index.php, p. V51 397 (1991)


5.8 Mechanism of Action

Theophylline relaxes the smooth muscle of the bronchial airways and pulmonary blood vessels and reduces airway responsiveness to histamine, methacholine, adenosine, and allergen. Theophylline competitively inhibits type III and type IV phosphodiesterase (PDE), the enzyme responsible for breaking down cyclic AMP in smooth muscle cells, possibly resulting in bronchodilation. Theophylline also binds to the adenosine A2B receptor and blocks adenosine mediated bronchoconstriction. In inflammatory states, theophylline activates histone deacetylase to prevent transcription of inflammatory genes that require the acetylation of histones for transcription to begin.


Theophylline is an old drug experiencing a renaissance owing to its beneficial antiinflammatory effects in chronic respiratory diseases, such as asthma and chronic obstructive pulmonary disease. Multiple modes of antiinflammatory action have been reported, including inhibition of the enzymes that degrade cAMP-phosphodiesterase (PDE). Using primary cultures of airway smooth muscle (ASM) cells, we recently revealed that PDE4 inhibitors can potentiate the antiinflammatory action of beta2-agonists by augmenting cAMP-dependent expression of the phosphatase that deactivates mitogen-activated protein kinase (MAPK)-MAPK phosphatase (MKP)-1. Therefore, the aim of this study was to address whether theophylline repressed cytokine production in a similar, PDE-dependent, MKP-1-mediated manner. Notably, theophylline did not potentiate cAMP release from ASM cells treated with the long-acting beta2-agonist formoterol. Moreover, theophylline (0.1-10 uM) did not increase formoterol-induced MKP-1 messenger RNA expression nor protein up-regulation, consistent with the lack of cAMP generation. However, theophylline (at 10 uM) was antiinflammatory and repressed secretion of the neutrophil chemoattractant cytokine IL-8, which is produced in response to TNF-a. Because theophylline's effects were independent of PDE4 inhibition or antiinflammatory MKP-1, we then wished to elucidate the novel mechanisms responsible. We investigated the impact of theophylline on protein phosphatase (PP) 2A, a master controller of multiple inflammatory signaling pathways, and show that theophylline increases TNF-a-induced PP2A activity in ASM cells. Confirmatory results were obtained in A549 lung epithelial cells. PP2A activators have beneficial effects in ex vivo and in vivo models of respiratory disease. Thus, our study is the first to link theophylline with PP2A activation as a novel mechanism to control respiratory inflammation.

PMID:26574643 Patel BS et al; Am J Respir Cell Mol Biol 54 (6): 792-801 (2016)


Theophylline has two distinct actions in the airways of patients with reversible obstruction; smooth muscle relaxation (i.e., bronchodilation) and suppression of the response of the airways to stimuli (i.e., non-bronchodilator prophylactic effects). While the mechanisms of action of theophylline are not known with certainty, studies in animals suggest that bronchodilatation is mediated by the inhibition of two isozymes of phosphodiesterase (PDE III and, to a lesser extent, PDE IV) while non-bronchodilator prophylactic actions are probably mediated through one or more different molecular mechanisms, that do not involve inhibition of PDE III or antagonism of adenosine receptors. Some of the adverse effects associated with theophylline appear to be mediated by inhibition of PDE III (e.g., hypotension, tachycardia, headache, and emesis) and adenosine receptor antagonism (e.g., alterations in cerebral blood flow). Theophylline increases the force of contraction of diaphragmatic muscles. This action appears to be due to enhancement of calcium uptake through an adenosine-mediated channel.

NIH; DailyMed. Current Medication Information for Theophylline (Anhydrous) Tablet, Extended Release (Updated: November 2014). Available from, as of July 21, 2016: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=038c2b07-8028-4dc4-847c-adafe1b0e81a


Lung deflation and inflation during cardiac surgery with cardiopulmonary bypass contributes to pulmonary dysfunction postoperatively. Theophylline treatment for lung diseases has traditionally been thought to act by phosphodiesterase inhibition; however, increasing evidence has suggested other plausible mechanisms. We investigated the effects of deflation and reinflation on signaling pathways (p38-mitogen-activated protein kinase [MAPK], extracellular signal-regulated kinase 1 and 2 [ERK1/2], and Akt) and whether theophylline influences the deflation-induced lung injury and associated signaling. Isolated rat lungs were perfused (15 mL/min) with deoxygenated rat blood in bicarbonate buffer and ventilated. After 20 minutes' equilibration, the lungs were deflated (60 minutes, aerobic perfusion 1.5 mL/min), followed by reinflation (60 minutes, anaerobic reperfusion 15 mL/min). Compliance, vascular resistance, and kinase phosphorylation were assessed during deflation and reinflation. The effects of SB203580 (50 uM), a p38-MAPK inhibitor, and theophylline (0.083 mM [therapeutic] or 3 mM [supratherapeutic]) on physiology and signaling were studied. Deflation reduced compliance by 44% compared with continuously ventilated lungs. p38-MAPK and Akt phosphorylation increased (three to fivefold) during deflation and reinflation, and ERK1/2 phosphorylation increased (approximately twofold) during reinflation. SB203580 had no effect on lung physiology or ERK1/2 and Akt activation. Both theophylline doses increased cyclic adenosine monophosphate, but only 3 mM theophylline improved compliance. p38-MAPK phosphorylation was not affected by theophylline; 0.083 mM theophylline inhibited reinflation-induced ERK1/2 phosphorylation (72% + or - 3%); and 3 mM theophylline inhibited Akt phosphorylation during deflation (75% + or - 5%) and reinflation (87% + or - 4%). Lung deflation and reinflation stimulates differential p38-MAPK, ERK1/2, and Akt activation, suggesting a role in lung injury during cardiopulmonary bypass. However, p38-MAPK was not involved in the compromised compliance. A supratherapeutic theophylline dose protected lungs against deflation-induced injury and was associated with inhibition of phosphoinositide 3-kinase/Akt rather than phosphodiesterase.

PMID:24841445 Full text: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4226635 Markou T, Chambers DJ; J Thorac Cardiovasc Surg 148 (5): 2335-44 (2014)


Theophylline and aminophylline have been widely used as inhibitors of phosphodiesterase when examining the role of cAMP in regulating cell function. In reality, however, these phosphodiesterase inhibitors may have additional sites of action that could complicate the interpretation of the results. These additional sites of action could include antagonism of inhibitory adenosine autoreceptors and release of intracellular calcium. The purpose of the present study was to determine which of the above three is the primary mechanism by which theophylline and aminophylline affect transmitter release at the mammalian neuromuscular junction. Quantal release measurements were made using intracellular recording techniques. A variety of drugs were used to elucidate this pathway. Isoproterenol, an adenylate cyclase activator, was first used to establish the effect of enhanced levels of cAMP. Theophylline application on its own or in the presence of a drug combination that blocked the adenosine receptor and phosphodiesterase pathways caused significant release depression, opposite to what is expected if it was functioning to enhance cAMP levels. However, when applied in the presence of a drug combination that blocked the adenosine receptor, phosphodiesterase and intracellular ryanodine calcium pathways, theophylline was unable to depress release. Therefore, it was concluded that the major mechanism of action of theophylline is depression of transmitter release by causing the release of intracellular calcium. Aminophylline application alone resulted in a significant enhancement of release. However, when coupled with an adenosine receptor blocker, the ability of aminophylline to enhance transmitter release was blocked, suggesting that its dominant mechanism of action is adenosine receptor inhibition. Taken together, these results indicate that the use of theophylline and aminophylline is inappropriate when examining the role of cAMP at the mammalian neuromuscular junction.

PMID:16700879 Nickels TJ et al; Clin Exp Pharmacol Physiol 33 (5-6): 465-70 (2006)


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I. D. C.,","city":"THANE, MAHARASHTRA.","supplier":"KENKO CORPORATION","supplierCountry":"CHINA","foreign_port":"QINGDAO","customer":"BAJAJ HEALTHCARE","customerCountry":"INDIA","quantity":"10000.00","actualQuantity":"10000","unit":"KGS","unitRateFc":"8.6","totalValueFC":"86480.8","currency":"USD","unitRateINR":"722.9","date":"25-Jul-2024","totalValueINR":"7229025","totalValueInUsd":"86480.8","indian_port":"JNPT","hs_no":"29395900","bill_no":"4695770","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"QINGDAO","supplierAddress":"4TH FLOOR,IWAMOTOCHO TOYO BLDG.,1-2,IWAMOTOCHO 3-CHOME CHIYODA-KU,101-0032,TOKYO JAPAN","customerAddress":"N - 216 N-217, M. I. D. C.,"}]
20-Jan-2021
30-Sep-2024
KGS
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Average Price (USD/KGS)

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country Total Quantity
(KGS)
Average Price
(USD/KGS)
Number of Transactions

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FDA Orange Book

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01

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The Pharmacy Technology
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

RLD : No

TE Code :

THEOPHYLLINE

Brand Name : SLO-PHYLLIN

Dosage Form : SYRUP;ORAL

Dosage Strength : 80MG/15ML

Approval Date : 1982-01-01

Application Number : 85187

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Sanofi Company Banner

02

arrow
The Pharmacy Technology
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

RLD : No

TE Code :

THEOPHYLLINE

Brand Name : SLO-PHYLLIN

Dosage Form : TABLET;ORAL

Dosage Strength : 200MG

Approval Date : 1982-01-01

Application Number : 85204

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Sanofi Company Banner

03

arrow
The Pharmacy Technology
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

RLD : No

TE Code :

THEOPHYLLINE

Brand Name : SLO-PHYLLIN

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : 250MG

Approval Date : 1982-05-24

Application Number : 85205

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Sanofi Company Banner

04

arrow
The Pharmacy Technology
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

RLD : No

TE Code :

THEOPHYLLINE

Brand Name : SLO-PHYLLIN

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : 60MG

Approval Date : 1982-05-24

Application Number : 85206

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Sanofi Company Banner

05

arrow
The Pharmacy Technology
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

RLD : No

TE Code :

THEOPHYLLINE

Brand Name : BRONKODYL

Dosage Form : CAPSULE;ORAL

Dosage Strength : 100MG

Approval Date : 1982-01-01

Application Number : 85264

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Sanofi Company Banner

06

arrow
The Pharmacy Technology
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

RLD : No

TE Code :

THEOPHYLLINE

Brand Name : BRONKODYL

Dosage Form : CAPSULE;ORAL

Dosage Strength : 200MG

Approval Date : 1982-01-01

Application Number : 85264

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Sanofi Company Banner

07

arrow
The Pharmacy Technology
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

RLD : No

TE Code :

THEOPHYLLINE

Brand Name : SLO-BID

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : 100MG

Approval Date : 1985-01-31

Application Number : 87892

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Sanofi Company Banner

08

arrow
The Pharmacy Technology
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

RLD : No

TE Code :

THEOPHYLLINE

Brand Name : SLO-BID

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : 50MG

Approval Date : 1985-01-31

Application Number : 88269

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Sanofi Company Banner

09

arrow
The Pharmacy Technology
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

RLD : No

TE Code :

THEOPHYLLINE

Brand Name : ACCURBRON

Dosage Form : SYRUP;ORAL

Dosage Strength : 150MG/15ML

Approval Date : 1985-11-22

Application Number : 88746

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Sanofi Company Banner

10

arrow
The Pharmacy Technology
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

RLD : No

TE Code :

THEOPHYLLINE

Brand Name : SLO-BID

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : 75MG

Approval Date : 1989-05-10

Application Number : 89539

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Sanofi Company Banner
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DRUG PRODUCT COMPOSITIONS

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DOSAGE - INJECTABLE;INJECTION - 160MG/100ML

USFDA APPLICATION NUMBER - 19211

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DOSAGE - INJECTABLE;INJECTION - 320MG/100ML

USFDA APPLICATION NUMBER - 19211

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DOSAGE - INJECTABLE;INJECTION - 40MG/100ML

USFDA APPLICATION NUMBER - 19211

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DOSAGE - INJECTABLE;INJECTION - 4MG/ML

USFDA APPLICATION NUMBER - 19211

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DOSAGE - SOLUTION, ELIXIR;ORAL - 80MG/15ML

USFDA APPLICATION NUMBER - 85186

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