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Pseudoephedrine Hydrochloride

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ACTIVE PHARMA INGREDIENTS

37 API Suppliers, 24 USDMF, 10 CEP/COS, 1 JDMF, 3 EU WC, 6 KDMF, 12 NDC API, 12 Listed Suppliers, $ API Reference Price

37 API Suppliers
24 USDMF
10 CEP/COS
1 JDMF
3 EU WC
6 KDMF
12 NDC API
12 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

3 Drugs in Development

3 Drugs in Development

FINISHED DOSAGE FORMULATIONS

312 FDF Dossiers, 112 FDA Orange Book, 3 Europe, 114 Canada, 50 South Africa, 33 Listed Dossiers

312 FDF Dossiers
112 FDA Orange Book
3 Europe
114 Canada
50 South Africa
33 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 200MG;30MG, CAPSULE;ORAL - 8MG;60MG, TABLET, EXTENDED RELEASE;ORAL - 240MG, TABLET, EXTENDED RELEASE;ORAL - 60MG;120MG, CAPSULE;ORAL - EQ 200MG FREE ACID AND POTASSIUM SALT;30MG, TABLET;ORAL - 2MG;200MG;30MG, TABLET, EXTENDED RELEASE;ORAL - 1.2GM;120MG, TABLET, EXTENDED RELEASE;ORAL - 600MG;60MG, TABLET, EXTENDED RELEASE;ORAL - 180MG;240MG, SOLUTION;ORAL - 200MG/5ML;2.5MG/5ML;30MG/5ML, SOLUTION;ORAL - 4MG/5ML;5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;ORAL - 5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SYRUP;ORAL - 2MG/5ML;10MG/5ML;30MG/5ML

drugProductComposition
TABLET;ORAL - 200MG;30MG
CAPSULE;ORAL - 8MG;60MG
TABLET, EXTENDED RELEASE;ORAL - 240MG
TABLET, EXTENDED RELEASE;ORAL - 60MG;120MG
CAPSULE;ORAL - EQ 200MG FREE ACID AND POTASSIUM SALT;30MG
TABLET;ORAL - 2MG;200MG;30MG
TABLET, EXTENDED RELEASE;ORAL - 1.2GM;120MG
TABLET, EXTENDED RELEASE;ORAL - 600MG;60MG
TABLET, EXTENDED RELEASE;ORAL - 180MG;240MG
SOLUTION;ORAL - 200MG/5ML;2.5MG/5ML;30MG/5ML
SOLUTION;ORAL - 4MG/5ML;5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
SOLUTION;ORAL - 5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
SYRUP;ORAL - 2MG/5ML;10MG/5ML;30MG/5ML

RELATED EXCIPIENT COMPANIES

1 Minakem, 9 Rochem International Inc, 21 SPI Pharma, 2 Seqens, 13 DKSH, 3 Jai Radhe Sales, 2 Pharm-RX Chemical, 9 Faran Shimi Pharmaceutical, 12 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 16 Gangwal Healthcare, 12 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 4 ACG Worldwide, 15 Actylis, 4 Aeon Procare, 3 Alcedo Pharmachem, 12 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 38 BASF, 1 Bioplus Life Sciences, 2 Clariant, 12 Corel Pharma Chem, 7 DFE Pharma, 2 Finar, 14 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 7 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 39 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 2 Lubrizol Life Science Health, 18 Microlex e.U, 2 Nanjing Bold Chemical, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 5 Novo Excipients, 5 Pharmatrans-Sanaq, 10 Pluviaendo, 5 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 37 Roquette, 14 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 3 The Dow Chemical Company, 4 Ulanqab Kema New Material, 1 Valens Pharmachem, 4 Vasa Pharmachem, 2 Vertellus, 2 Zhejiang Huakang Pharmaceutical

relatedExcipients
1 Minakem
9 Rochem International Inc
21 SPI Pharma
2 Seqens
13 DKSH
3 Jai Radhe Sales
2 Pharm-RX Chemical
9 Faran Shimi Pharmaceutical
12 Boai NKY Pharmaceuticals Ltd
1 Chynops Pharma
16 Gangwal Healthcare
12 Nanjing Well Pharmaceutical
2 Pfanstiehl
4 ACG Worldwide
15 Actylis
4 Aeon Procare
3 Alcedo Pharmachem
12 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
38 BASF
1 Bioplus Life Sciences
2 Clariant
12 Corel Pharma Chem
7 DFE Pharma
2 Finar
14 Gangwal Chemicals
1 Huzhou Sunflower Pharmaceutical
7 Ideal Cures Pvt Ltd
5 Ingredion Pharma Solutions
39 Kerry
4 Kima Chemical
6 Lonza Capsugel
2 Lubrizol Life Science Health
18 Microlex e.U
2 Nanjing Bold Chemical
1 NEWEDGE Overseas
2 Nomisma Healthcare
5 Novo Excipients
5 Pharmatrans-Sanaq
10 Pluviaendo
5 Prachin Chemical
1 Qianhao Chemical (Hebei) Co., Ltd
2 Qualicaps
37 Roquette
14 Seppic
7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd
1 Shanghai Welltone Material Technology Co., Ltd
2 Shijiazhuang Huaxu Pharmaceutical
12 Sigachi Industries
3 The Dow Chemical Company
4 Ulanqab Kema New Material
1 Valens Pharmachem
4 Vasa Pharmachem
2 Vertellus
2 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

127 Fillers, Diluents & Binders, 63 Coating Systems & Additives, 59 Direct Compression, 47 Disintegrants & Superdisintegrants, 45 Thickeners and Stabilizers, 42 Controlled & Modified Release, 37 Granulation, 36 Taste Masking, 36 Solubilizers, 35 Film Formers & Plasticizers, 31 Topical, 31 Lubricants & Glidants, 29 Parenteral, 25 Chewable & Orodispersible Aids, 23 Co-Processed Excipients, 11 API Stability Enhancers, 10 Emulsifying Agents, 9 Rheology Modifiers, 9 Empty Capsules, 5 Coloring Agents, 5 Surfactant & Foaming Agents, 4 Vegetarian Capsules, 1 Soft Gelatin

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 31 NEWS #PharmaBuzz

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1 DATA COMPILATION #PharmaFlow
31 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 Finished Drug Prices

globalSalesInformation
1 Finished Drug Prices

MARKET PLACE

24 APIs

marketPlace
24 APIs

PATENTS & EXCLUSIVITIES

2 US Patents

patents
2 US Patents

REF. STANDARDS & IMPURITIES

1 EDQM , 1 USP , 1 Others

otherSolutions
1 EDQM
1 USP
1 Others

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 53

MARKET PLACE

API

FDF

0INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

312

FDF Dossiers

112

FDA Orange Book

Europe

114

Canada

Australia

South Africa

Listed Dossiers

3DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

Annual Reports (USD Million)

Finished Drug Prices

421 RELATED EXCIPIENT COMPANIES

720EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: Pseudoephedrine hcl, 345-78-8, Otrinol, Rhinalair, Tussaphed, Novafed

Molecular Formula

C₁₀H₁₆ClNO

Molecular Weight

201.69 g/mol

InChI Key

BALXUFOVQVENIU-KXNXZCPBSA-N

FDA UNII

6V9V2RYJ8N

A phenethylamine that is an isomer of EPHEDRINE which has less central nervous system effects and usage is mainly for respiratory tract decongestion.

1 2D Structure

Pseudoephedrine Hydrochloride

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

(1S,2S)-2-(methylamino)-1-phenylpropan-1-ol;hydrochloride

2.1.2 InChI

InChI=1S/C10H15NO.ClH/c1-8(11-2)10(12)9-6-4-3-5-7-9;/h3-8,10-12H,1-2H3;1H/t8-,10+;/m0./s1

2.1.3 InChI Key

BALXUFOVQVENIU-KXNXZCPBSA-N

2.1.4 Canonical SMILES

CC(C(C1=CC=CC=C1)O)NC.Cl

2.1.5 Isomeric SMILES

C[C@@H]([C@H](C1=CC=CC=C1)O)NC.Cl

2.2 Other Identifiers

2.2.1 UNII

6V9V2RYJ8N

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Ephedrine Threo Isomer

2. Isoephedrine

3. Pseudoephedrine

4. Pseudoephedrine Hcl

5. Sudafed

6. Threo Isomer Of Ephedrine

2.3.2 Depositor-Supplied Synonyms

1. Pseudoephedrine Hcl

2. 345-78-8

3. Otrinol

4. Rhinalair

5. Tussaphed

6. Novafed

7. Sudafed

8. Sudomyl

9. First Sign

10. D-pseudoephedrine Hydrochloride

11. Besan

12. Sudafed Hydrochloride

13. (+)-pseudoephedrine Hydrochloride

14. Pseudophedrine Hydrochloride

15. Galsud

16. Efidac 24

17. 1s,2s-(+)-pseudoephedrine Hydrochloride

18. Nsc-33634

19. Nsc-106567

20. 6v9v2ryj8n

21. L(+)-pseudoephedrine Hydrochloride

22. Sinufed

23. Coadvil

24. Symptom 2

25. D-(alpha-(1-methylamino)ethyl)benzyl Alcohol Hydrochloride

26. Sudafed 12 Hour

27. Pseudoephedrine, (+)-

28. Pseudoephedrine, L-(+)-

29. Suphedrine

30. Nexafed

31. Dorcol

32. Histalet Syrup

33. L-(+)-pseudoephedrine Hydrochloride

34. Sun Mark Sinus

35. Deconsal Ii

36. Chebi:8604

37. Sudafed Liquid, Children's

38. Pediacare Decongestant Drops

39. Sudafed 24 Hour

40. (1s,2s)-2-(methylamino)-1-phenylpropan-1-ol Hydrochloride

41. Benzenemethanol, Hydrochloride, S-(r,r)-

42. Wln: Qyr & Y1 & M1 & Gh-l

43. Dimetapp Decongestant

44. Actifed Sinus Daytime

45. Cpdd 0050

46. Benzenemethanol, Hydrochloride, [s-(r*,r*)]-

47. Einecs 206-462-1

48. Pseudoephedrine Hydrochloride [usan]

49. Nsc 33634

50. Unii-6v9v2ryj8n

51. Nsc 106567

52. (1s,2s)-2-(methylamino)-1-phenylpropan-1-ol;hydrochloride

53. Topcare 12 Hour Decongestant

54. D-[.alpha.-(1-methylamino)ethyl]benzyl Alcohol Hydrochloride

55. Ornex And Maximum Strength Ornex

56. Sudafed (tn)

57. Galpseud

58. Pseudoephedrine, Hydrochloride, L-(+)-

59. Pseudoephedrine Hydrochloride [usan:usp]

60. Tylenol Sinus Medication, Maximum Strength

61. Isoephedrine Hydrochloride

62. Contac Day & Night Allergy Sinus Day Caplets

63. Psi-ephedrine Hydrochloride

64. Benzenemethanol, Alpha-(1-(methylamino)ethyl)-, Hydrochloride, (s-(r*,r*))-

65. Ec 206-462-1

66. Schembl33285

67. Mls001304069

68. Spectrum1500516

69. Chembl1200724

70. Sine-off Maximum Strength No Drowsiness Formula Caplets

71. Dtxsid10889343

72. Hms1920n04

73. Pharmakon1600-01500516

74. Nsc33634

75. Pseudoephedrine Hydrochloride (usp)

76. Ccg-39241

77. Nsc106567

78. Nsc759616

79. Akos027383893

80. Benzenemethanol, Alpha-(1-(methylamino)ethyl)-, (s-(r*,r*))-, Hydrochloride

81. Nsc-759616

82. Benzenemethanol, .alpha.-[(1s)-1-(methylamino)ethyl]-, Hydrochloride, (.alpha.s)-

83. Benzenemethanol, Alpha-((1s)-1-(methylamino)ethyl)-, Hydrochloride, (alphas)-

84. Benzenemethanol, Alpha-(1-(methylamino)ethyl)-, Hydrochloride, (s-(theta,theta))-

85. Pseudoephedrine Hydrochloride [mi]

86. Smr000718787

87. (+)-pseudoephedrine Hydrochloride, >=98%

88. P1654

89. Pseudoephedrine Hydrochloride [mart.]

90. Pseudoephedrine Hydrochloride [vandf]

91. Pseudoephedrine Hydrochloride [usp-rs]

92. Pseudoephedrine Hydrochloride [who-dd]

93. D00485

94. 345p788

95. Pseudoephedrine Hydrochloride [orange Book]

96. Myfed Component Pseudoephedrine Hydrochloride

97. Pseudoephedrine Hydrochloride [ep Monograph]

98. Pseudoephedrine Hydrochloride [usp Monograph]

99. W-106727

100. Actahist Component Pseudoephedrine Hydrochloride

101. Actifed Component Pseudoephedrine Hydrochloride

102. Aleve-d Component Pseudoephedrine Hydrochloride

103. Allerfed Component Pseudoephedrine Hydrochloride

104. Corphed Component Pseudoephedrine Hydrochloride

105. Histafed Component Pseudoephedrine Hydrochloride

106. Isoclor Component Pseudoephedrine Hydrochloride

107. Pseudoephedrine Hydrochloride Component Of Myfed

108. Q27108108

109. Triphed Component Pseudoephedrine Hydrochloride

110. Zyrtec-d Component Pseudoephedrine Hydrochloride

111. Allegra-d Component Pseudoephedrine Hydrochloride

112. Bromfed-dm Component Pseudoephedrine Hydrochloride

113. Mucinex D Component Pseudoephedrine Hydrochloride

114. Pseudoephedrine Hydrochloride Component Of Actifed

115. Pseudoephedrine Hydrochloride Component Of Aleve-d

116. Pseudoephedrine Hydrochloride Component Of Corphed

117. Pseudoephedrine Hydrochloride Component Of Isoclor

118. Pseudoephedrine Hydrochloride Component Of Triphed

119. Semprex-d Component Pseudoephedrine Hydrochloride

120. Triacin-c Component Pseudoephedrine Hydrochloride

121. Trilitron Component Pseudoephedrine Hydrochloride

122. (+)-pseudoephedrine Hydrochloride, Sigma Reference Standard

123. Bromanate Dm Component Pseudoephedrine Hydrochloride

124. Dimetane-dx Component Pseudoephedrine Hydrochloride

125. Hycofenix Component Of Pseudoephedrine Hydrochloride

126. Pseudoephedrine Hydrochloride Component Of Actahist

127. Pseudoephedrine Hydrochloride Component Of Allegra-d

128. Pseudoephedrine Hydrochloride Component Of Allerfed

129. Pseudoephedrine Hydrochloride Component Of Bromfed-dm

130. Pseudoephedrine Hydrochloride Component Of Histafed

131. Pseudoephedrine Hydrochloride Component Of Hycofenix

132. Pseudoephedrine Hydrochloride Component Of Mucinex D

133. Pseudoephedrine Hydrochloride Component Of Semprex-d

134. Pseudoephedrine Hydrochloride Component Of Triacin-c

135. Pseudoephedrine Hydrochloride Component Of Trilitron

136. Pseudoephedrine Hydrochloride Component Of Zyrtec-d

137. Pseudoephedrine Hydrochloride; Threo-ephedrine Hydrochloride

138. Sine-aid Ib Component Pseudoephedrine Hydrochloride

139. (1s,2s)-2-(methylamino)-1-phenyl-1-propanol Hydrochloride

140. Codimal-l.a. 12 Component Pseudoephedrine Hydrochloride

141. Pseudoephedrine Hydrochloride Component Of Bromanate Dm

142. Pseudoephedrine Hydrochloride Component Of Dimetane-dx

143. Pseudoephedrine Hydrochloride Component Of Sine-aid Ib

144. Advil Allergy Sinus Component Pseudoephedrine Hydrochloride

145. Children's Advil Cold Component Pseudoephedrine Hydrochloride

146. Children's Motrin Cold Component Pseudoephedrine Hydrochloride

147. Pseudoephedrine Hydrochloride Component Of Advil Allergy Sinus

148. Pseudoephedrine Hydrochloride Component Of Codimal-l.a. 12

149. (+)-pseudoephedrine Hydrochloride 1.0 Mg/ml In Methanol (as Free Base)

150. Pseudoephedrine Hydrochloride Component Of Children's Advil Cold

151. Pseudoephedrine Hydrochloride Component Of Children's Motrin Cold

152. Pseudoephedrine Hydrochloride, British Pharmacopoeia (bp) Reference Standard

153. Benzenemethanol, .alpha.-[(1s)-1-(methylamino)ethyl]-, Hydrochloride (1:1), (.alpha.s)-

154. Benzenemethanol, Alpha-((1s)-1-(methylamino)ethyl)-, Hydrochloride (1:1), (alphas)-

155. Pseudoephedrine Hydrochloride, European Pharmacopoeia (ep) Reference Standard

156. Pseudoephedrine Hydrochloride, United States Pharmacopeia (usp) Reference Standard

157. Pseudoephedrine Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material

2.4 Create Date

2005-06-24

3 Chemical and Physical Properties

Molecular Formula	C₁₀H₁₆ClNO
Molecular Weight	201.69 g/mol
Hydrogen Bond Donor Count	3
Hydrogen Bond Acceptor Count	2
Rotatable Bond Count	3
Exact Mass	201.0920418 g/mol
Monoisotopic Mass	201.0920418 g/mol
Topological Polar Surface Area	32.3 Å²
Heavy Atom Count	13
Formal Charge	0
Complexity	121
Isotope Atom Count	0
Defined Atom Stereocenter Count	2
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

4 Drug and Medication Information

4.1 Drug Information

1 of 6
Drug Name	Pseudoephedrine hydrochloride
Drug Label	Active ingredient (in each 5 mL) Purpose Pseudoephedrine hydrochloride 15 mg .............. Nasal decongestant...
Active Ingredient	Pseudoephedrine hydrochloride
Dosage Form	Tablet, extended release
Route	Oral
Strength	120mg
Market Status	Over the Counter
Company	Ranbaxy; Perrigo

2 of 6
Drug Name	Sudafed 12 hour
Active Ingredient	Pseudoephedrine hydrochloride
Dosage Form	Tablet, extended release
Route	Oral
Strength	120mg
Market Status	Over the Counter
Company	Mcneil Cons

3 of 6
Drug Name	Sudafed 24 hour
Active Ingredient	Pseudoephedrine hydrochloride
Dosage Form	Tablet, extended release
Route	Oral
Strength	240mg
Market Status	Over the Counter
Company	Mcneil Cons

4 of 6
Drug Name	Pseudoephedrine hydrochloride
Drug Label	Active ingredient (in each 5 mL) Purpose Pseudoephedrine hydrochloride 15 mg .............. Nasal decongestant...
Active Ingredient	Pseudoephedrine hydrochloride
Dosage Form	Tablet, extended release
Route	Oral
Strength	120mg
Market Status	Over the Counter
Company	Ranbaxy; Perrigo

5 of 6
Drug Name	Sudafed 12 hour
Active Ingredient	Pseudoephedrine hydrochloride
Dosage Form	Tablet, extended release
Route	Oral
Strength	120mg
Market Status	Over the Counter
Company	Mcneil Cons

6 of 6
Drug Name	Sudafed 24 hour
Active Ingredient	Pseudoephedrine hydrochloride
Dosage Form	Tablet, extended release
Route	Oral
Strength	240mg
Market Status	Over the Counter
Company	Mcneil Cons

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Bronchodilator Agents

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

Nasal Decongestants

Drugs designed to treat inflammation of the nasal passages, generally the result of an infection (more often than not the common cold) or an allergy related condition, e.g., hay fever. The inflammation involves swelling of the mucous membrane that lines the nasal passages and results in inordinate mucus production. The primary class of nasal decongestants are vasoconstrictor agents. (From PharmAssist, The Family Guide to Health and Medicine, 1993) (See all compounds classified as Nasal Decongestants.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

alpha-Adrenergic Agonist [EPC]; Adrenergic alpha-Agonists [MoA]

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API Reference Price

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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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DOSAGE - TABLET;ORAL - 200MG;30MG

USFDA APPLICATION NUMBER - 19771

DOSAGE - CAPSULE;ORAL - 8MG;60MG

USFDA APPLICATION NUMBER - 19806

DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 240M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 240MG

USFDA APPLICATION NUMBER - 20021

DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 60MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 60MG;120MG

USFDA APPLICATION NUMBER - 20786

DOSAGE - CAPSULE;ORAL - EQ 200MG FREE ACID AN...DOSAGE - CAPSULE;ORAL - EQ 200MG FREE ACID AND POTASSIUM SALT;30MG

USFDA APPLICATION NUMBER - 21374

DOSAGE - TABLET;ORAL - 2MG;200MG;30MG

USFDA APPLICATION NUMBER - 21441

DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1.2G...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1.2GM;120MG

USFDA APPLICATION NUMBER - 21585

DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 600M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 600MG;60MG

USFDA APPLICATION NUMBER - 21585

DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 180M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 180MG;240MG

USFDA APPLICATION NUMBER - 21704

DOSAGE - SOLUTION;ORAL - 200MG/5ML;2.5MG/5ML;...DOSAGE - SOLUTION;ORAL - 200MG/5ML;2.5MG/5ML;30MG/5ML

USFDA APPLICATION NUMBER - 22279

DOSAGE - SOLUTION;ORAL - 4MG/5ML;5MG/5ML;60MG...DOSAGE - SOLUTION;ORAL - 4MG/5ML;5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 22439

DOSAGE - SOLUTION;ORAL - 5MG/5ML;60MG/5ML **F...DOSAGE - SOLUTION;ORAL - 5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 22442

DOSAGE - SYRUP;ORAL - 2MG/5ML;10MG/5ML;30MG/5...DOSAGE - SYRUP;ORAL - 2MG/5ML;10MG/5ML;30MG/5ML

USFDA APPLICATION NUMBER - 88811

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ACTIVE PHARMA INGREDIENTS

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$ API Reference Price

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DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 200MG;30MG

CAPSULE;ORAL - 8MG;60MG

TABLET, EXTENDED RELEASE;ORAL - 240MG

TABLET, EXTENDED RELEASE;ORAL - 60MG;120MG

CAPSULE;ORAL - EQ 200MG FREE ACID AND POTASSIUM SALT;30MG

TABLET;ORAL - 2MG;200MG;30MG

TABLET, EXTENDED RELEASE;ORAL - 1.2GM;120MG

TABLET, EXTENDED RELEASE;ORAL - 600MG;60MG

TABLET, EXTENDED RELEASE;ORAL - 180MG;240MG

SOLUTION;ORAL - 200MG/5ML;2.5MG/5ML;30MG/5ML

SOLUTION;ORAL - 4MG/5ML;5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

SOLUTION;ORAL - 5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

SYRUP;ORAL - 2MG/5ML;10MG/5ML;30MG/5ML

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SOLUTION;ORAL - 4MG/5ML;5MG/5ML;60MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

SOLUTION;ORAL - 5MG/5ML;60MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons