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ACTIVE PHARMA INGREDIENTS

83 API Suppliers, 37 USDMF, 27 CEP/COS, 7 JDMF, 18 EU WC, 69 KDMF, 22 NDC API, 43 Listed Suppliers, $ API Reference Price

83 API Suppliers
37 USDMF
27 CEP/COS
7 JDMF
18 EU WC
69 KDMF
22 NDC API
43 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

15 Drugs in Development

15 Drugs in Development

INTERMEDIATES

2 Intermediates Suppliers

2 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

786 FDF Dossiers, 80 FDA Orange Book, 417 Europe, 35 Canada, 50 Australia, 64 South Africa, 140 Listed Dossiers

786 FDF Dossiers
80 FDA Orange Book
417 Europe
35 Canada
50 Australia
64 South Africa
140 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 325MG;37.5MG, TABLET, EXTENDED RELEASE;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 100MG, CAPSULE, EXTENDED RELEASE;ORAL - 150MG, CAPSULE, EXTENDED RELEASE;ORAL - 200MG, CAPSULE, EXTENDED RELEASE;ORAL - 300MG

drugProductComposition
TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 325MG;37.5MG
TABLET, EXTENDED RELEASE;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
CAPSULE, EXTENDED RELEASE;ORAL - 100MG
CAPSULE, EXTENDED RELEASE;ORAL - 150MG
CAPSULE, EXTENDED RELEASE;ORAL - 200MG
CAPSULE, EXTENDED RELEASE;ORAL - 300MG

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

EXCIPIENTS BY APPLICATIONS

103 Fillers, Diluents & Binders, 59 Coating Systems & Additives, 49 Direct Compression, 45 Disintegrants & Superdisintegrants, 39 Thickeners and Stabilizers, 35 Controlled & Modified Release, 34 Solubilizers, 33 Granulation, 30 Lubricants & Glidants, 27 Topical, 23 Parenteral, 23 Film Formers & Plasticizers, 23 Co-Processed Excipients, 19 Chewable & Orodispersible Aids, 19 Taste Masking, 11 Emulsifying Agents, 9 Empty Capsules, 9 API Stability Enhancers, 7 Rheology Modifiers, 7 Surfactant & Foaming Agents, 5 Coloring Agents, 4 Vegetarian Capsules

DIGITAL CONTENT

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4 DATA COMPILATION #PharmaFlow
62 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 387 Finished Drug Prices

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2 US Medicaid Prescriptions
387 Finished Drug Prices

MARKET PLACE

58 APIs, 27 FDF Dossiers

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58 APIs
27 FDF Dossiers

PATENTS & EXCLUSIVITIES

9 US Patents, 1 US Exclusivities, 12 Health Canada Patents

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9 US Patents
1 US Exclusivities
12 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM , 1 USP , 6 Others

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1 USP
6 Others

ANALYTICAL

2 BioAnalytical Methods

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2 BioAnalytical Methods

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 69

MARKET PLACE

API

FDF

2INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

786

FDF Dossiers

FDA Orange Book

417

Europe

Canada

Australia

South Africa

140

Listed Dossiers

15DRUGS 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)

94,225,286

Annual Reports (USD Million)

Finished Drug Prices

350 RELATED EXCIPIENT COMPANIES

613EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 36282-47-0, Contramal, (+)-tramadol hydrochloride, Tradonal, 148229-78-1, Cis-tramadol hydrochloride

Molecular Formula

C₁₆H₂₆ClNO₂

Molecular Weight

299.83 g/mol

InChI Key

PPKXEPBICJTCRU-XMZRARIVSA-N

FDA UNII

9N7R477WCK

A narcotic analgesic proposed for severe pain. It may be habituating.

1 2D Structure

Tramadol Hydrochloride

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

(1R,2R)-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexan-1-ol;hydrochloride

2.1.2 InChI

InChI=1S/C16H25NO2.ClH/c1-17(2)12-14-7-4-5-10-16(14,18)13-8-6-9-15(11-13)19-3;/h6,8-9,11,14,18H,4-5,7,10,12H2,1-3H3;1H/t14-,16+;/m1./s1

2.1.3 InChI Key

PPKXEPBICJTCRU-XMZRARIVSA-N

2.1.4 Canonical SMILES

CN(C)CC1CCCCC1(C2=CC(=CC=C2)OC)O.Cl

2.1.5 Isomeric SMILES

CN(C)C[C@H]1CCCC[C@@]1(C2=CC(=CC=C2)OC)O.Cl

2.2 Other Identifiers

2.2.1 UNII

9N7R477WCK

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Adolonta

2. Amadol

3. Biodalgic

4. Biokanol

5. Contramal

6. Jutadol

7. K 315

8. K-315

9. K315

10. Mtw Tramadol

11. Mtw-tramadol

12. Mtwtramadol

13. Nobligan

14. Prontofort

15. Ranitidin 1a Pharma

16. Takadol

17. Theradol

18. Tiral

19. Topalgic

20. Tradol

21. Tradol Puren

22. Tradol-puren

23. Tradolpuren

24. Tradonal

25. Tralgiol

26. Trama 1a Pharma

27. Trama Abz

28. Trama Dorsch

29. Trama Kd

30. Trama-dorsch

31. Tramabeta

32. Tramadin

33. Tramadoc

34. Tramadol

35. Tramadol 1a

36. Tramadol Acis

37. Tramadol Al

38. Tramadol Asta Medica

39. Tramadol Basics

40. Tramadol Bayvit

41. Tramadol Bexal

42. Tramadol Cinfa

43. Tramadol Dolgit

44. Tramadol Edigen

45. Tramadol Hameln

46. Tramadol Heumann

47. Tramadol Kern

48. Tramadol Lichtenstein

49. Tramadol Lindo

50. Tramadol Mabo

51. Tramadol Normon

52. Tramadol Pb

53. Tramadol Ratiopharm

54. Tramadol Stada

55. Tramadol-dolgit

56. Tramadol-hameln

57. Tramadol-ratiopharm

58. Tramadoldolgit

59. Tramadolhameln

60. Tramadolor

61. Tramadolratiopharm

62. Tramadorsch

63. Tramadura

64. Tramagetic

65. Tramagit

66. Tramake

67. Tramal

68. Tramex

69. Tramundin

70. Trasedal

71. Ultram

72. Xymel 50

73. Zamudol

74. Zumalgic

75. Zydol

76. Zytram

2.3.2 Depositor-Supplied Synonyms

1. 36282-47-0

2. Contramal

3. (+)-tramadol Hydrochloride

4. Tradonal

5. 148229-78-1

6. Cis-tramadol Hydrochloride

7. Tramadol Hcl

8. Amadol

9. Zydol

10. Conzip

11. 22204-88-2

12. Tramal

13. Zydol Hydrochloride

14. Crispin

15. Ryzolt

16. Cg-315e

17. 9n7r477wck

18. 194602-08-9

19. Bellatram

20. Omnidol

21. Zumatran

22. Chebi:75733

23. Radol

24. Tadol

25. (1r,2r)-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexan-1-ol;hydrochloride

26. Melanate

27. Poltram

28. Tramadex

29. Tramagetic

30. Tramazac

31. U-26225a

32. Dolana

33. Mabron

34. Trabar

35. Tramed

36. Tramol

37. Tridol

38. U-26,225a

39. Tradol-puren

40. (1r,2r)-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol Hydrochloride

41. Cyclohexanol, 2-((dimethylamino)methyl)-1-(3-methoxyphenyl)-, Hydrochloride, (1r,2r)-rel-

42. Zamudol

43. Zertane

44. Tramadolhydrochloride

45. Adolanta

46. Cemadol

47. Synapryn

48. Tridural

49. Rybix

50. Viotra

51. Tramal Retard

52. Ira-tramadol

53. Ultram Er

54. Cyclohexanol, 2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)-,hydrochloride, (1r,2r)-rel-

55. Rybix Odt

56. Cg 315

57. Smr000449308

58. Tramadol Hydrochloride Civ

59. Tramadol Related Compound A

60. Zydol Xl 150

61. Einecs 252-950-2

62. Unii-9n7r477wck

63. Tramundin

64. Cg-315

65. Nih-10969

66. Nsc-759105

67. (1r,2r)-2-((dimethylamino)methyl)-1-(3-methoxyphenyl)cyclohexanol Hydrochloride

68. (1r,2r)-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexan-1-ol Hydrochloride

69. Nih 10969

70. Ultram (tn)

71. Qdolo

72. Tramadole Hydrochloride

73. Tramadol/hcl

74. Tramadol Hydrochloride [usan:usp:jan]

75. (+-)-cis-2-((dimethylamino)methyl)-1-(m-methoxyphenyl)cyclohexanol Hydrochloride

76. Cyclohexanol, 2-((dimethylamino)methyl)-1-(3-methoxyphenyl)-, Hydrochloride, Cis-

77. Schembl41748

78. (r,r)-tramadol Hydrochloride

79. 53611-16-8

80. Mls000758218

81. Mls001424208

82. Chembl1200336

83. Dtxsid7023691

84. Hy-b0582a

85. Tramadol Hydrochloride, Ep Grade

86. Dtxsid60933340

87. (1rs,2sr)-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol Hydrochloride

88. Tramadol Hydrochloride [mi]

89. 3,3,4,4-terephthaloydiphthalicacid

90. Tramadol Hydrochloride (jp17/usp)

91. Tramadol Hydrochloride [jan]

92. Ac-796

93. Mfcd00798507

94. Tramadol Hydrochloride [hsdb]

95. Tramadol Hydrochloride [usan]

96. Tramadol Hydrochloride [vandf]

97. (+)-(1r,2r)-tramadol Hydrochloride

98. Akos015907739

99. Tramadol Hydrochloride [mart.]

100. Ccg-101135

101. Ks-1124

102. Nc00385

103. Nsc 759105

104. Tramadol Hydrochloride [who-dd]

105. (+-)-cis-2-((dimethylamino)methyl)-1-(3-methoxyphenyl)cyclohexanol Hydrochloride

106. Bt162445

107. Tramadol Hydrochloride [orange Book]

108. Tramadol Hydrochloride Civ [usp-rs]

109. Tramadol Hydrochloride, >=99.0% (hplc)

110. Tramadol Hydrochloride [ep Monograph]

111. Tramadol Hydrochloride [usp Monograph]

112. D01355

113. Tramadol Hydrochloride, >=98% (hplc), Solid

114. Ultracet Component Tramadol Hydrochloride

115. 204t882

116. Sr-01000759320

117. Tramadol Hydrochloride Component Of Ultracet

118. Q-201847

119. Sr-01000759320-5

120. Q27145507

121. Tramadol Hydrochloride 1.0 Mg/ml In Methanol (as Free Base)

122. (+)-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol Hydrochloride

123. Tramadol Hydrochloride, British Pharmacopoeia (bp) Reference Standard

124. Tramadol Hydrochloride, European Pharmacopoeia (ep) Reference Standard

125. Tramadol Hydrochloride, United States Pharmacopeia (usp) Reference Standard

126. (+/-)-cis-2-((dimethylamino)methyl)-1-(m-methoxyphenyl)cyclohexanol Hydrochloride

127. (1r,2r)-2-(dimethylaminomethyl)-1-(3-methoxyphenyl)-cyclohexanol Hydrochloride

128. [(1r,2r)-2-hydroxy-2-(3-methoxyphenyl)cyclohexyl]-n,n-dimethylmethanaminium Chloride

129. 2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexan-1-ol--hydrogen Chloride (1/1)

130. Cyclohexanol, 2-((dimethylamino)methyl)-1-(3-methoxyphenyl)-, Hydrochloride, Cis-(+-)-

131. Cis-tramadol Hydrochloride Solution, 1.0 Mg/ml In Methanol (as Free Base), Ampule Of 1 Ml, Certified Reference Material

132. Cyclohexanol, 2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)-, (1r,2r)-, Hydrochloride (1:1)

2.4 Create Date

2005-06-24

3 Chemical and Physical Properties

Molecular Formula	C₁₆H₂₆ClNO₂
Molecular Weight	299.83 g/mol
Hydrogen Bond Donor Count	2
Hydrogen Bond Acceptor Count	3
Rotatable Bond Count	4
Exact Mass	299.1652068 g/mol
Monoisotopic Mass	299.1652068 g/mol
Topological Polar Surface Area	32.7 Å²
Heavy Atom Count	20
Formal Charge	0
Complexity	282
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	Conzip
PubMed Health	Tramadol (By mouth)
Drug Classes	Analgesic
Drug Label	ConZip (tramadol hydrochloride) capsules is a centrally acting synthetic analgesic in an extended-release oral formulation. The chemical name for tramadol hydrochloride is ()cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochl...
Active Ingredient	Tramadol hydrochloride
Dosage Form	Capsule, extended release
Route	Oral
Strength	300mg; 200mg; 100mg; 150mg
Market Status	Prescription
Company	Cipher Pharms

2 of 6
Drug Name	Tramadol hydrochloride
PubMed Health	Tramadol (By mouth)
Drug Classes	Analgesic
Drug Label	Tramadol hydrochloride is a centrally acting synthetic analgesic in an extended-release formulation. The chemical name is ()cis-2-[(dimethylamino) methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is: Figure 1The molecu...
Active Ingredient	Tramadol hydrochloride
Dosage Form	Tablet, extended release; Tablet
Route	Oral
Strength	200mg; 300mg; 100mg; 50mg
Market Status	Prescription
Company	Anchen Pharms; Amneal Pharms; Mylan Pharms; Teva; Apotex; Accord Hlthcare; Aurobindo Pharma; Cspc Ouyi Pharm; Sun Pharm Inds; Lupin; Mallinckrodt; Allied Pharma; Northstar Hlthcare; Sun Pharma Global; Par Pharm; Actavis Elizabeth; Ipca Labs; Mutual Pharm;

3 of 6
Drug Name	Ultram er
Drug Label	ULTRAMER (tramadol hydrochloride) is a centrally acting synthetic analgesic in an extended-release formulation. The chemical name is (cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is:Figure 1The...
Active Ingredient	Tramadol hydrochloride
Dosage Form	Tablet, extended release
Route	Oral
Strength	200mg; 300mg; 100mg
Market Status	Prescription
Company	Valeant Intl

4 of 6
Drug Name	Conzip
PubMed Health	Tramadol (By mouth)
Drug Classes	Analgesic
Drug Label	ConZip (tramadol hydrochloride) capsules is a centrally acting synthetic analgesic in an extended-release oral formulation. The chemical name for tramadol hydrochloride is ()cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochl...
Active Ingredient	Tramadol hydrochloride
Dosage Form	Capsule, extended release
Route	Oral
Strength	300mg; 200mg; 100mg; 150mg
Market Status	Prescription
Company	Cipher Pharms

5 of 6
Drug Name	Tramadol hydrochloride
PubMed Health	Tramadol (By mouth)
Drug Classes	Analgesic
Drug Label	Tramadol hydrochloride is a centrally acting synthetic analgesic in an extended-release formulation. The chemical name is ()cis-2-[(dimethylamino) methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is: Figure 1The molecu...
Active Ingredient	Tramadol hydrochloride
Dosage Form	Tablet, extended release; Tablet
Route	Oral
Strength	200mg; 300mg; 100mg; 50mg
Market Status	Prescription
Company	Anchen Pharms; Amneal Pharms; Mylan Pharms; Teva; Apotex; Accord Hlthcare; Aurobindo Pharma; Cspc Ouyi Pharm; Sun Pharm Inds; Lupin; Mallinckrodt; Allied Pharma; Northstar Hlthcare; Sun Pharma Global; Par Pharm; Actavis Elizabeth; Ipca Labs; Mutual Pharm;

6 of 6
Drug Name	Ultram er
Drug Label	ULTRAMER (tramadol hydrochloride) is a centrally acting synthetic analgesic in an extended-release formulation. The chemical name is (cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is:Figure 1The...
Active Ingredient	Tramadol hydrochloride
Dosage Form	Tablet, extended release
Route	Oral
Strength	200mg; 300mg; 100mg
Market Status	Prescription
Company	Valeant Intl

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Analgesics, Opioid

Compounds with activity like OPIATE ALKALOIDS, acting at OPIOID RECEPTORS. Properties include induction of ANALGESIA or NARCOSIS. (See all compounds classified as Analgesics, Opioid.)

Narcotics

Agents that induce NARCOSIS. Narcotics include agents that cause somnolence or induced sleep (STUPOR); natural or synthetic derivatives of OPIUM or MORPHINE or any substance that has such effects. They are potent inducers of ANALGESIA and OPIOID-RELATED DISORDERS. (See all compounds classified as Narcotics.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Opioid Agonist [EPC]; Full Opioid Agonists [MoA]

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API Reference Price

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P.O.Box 3158, 4970602 Israel SDNF Israel","customerAddress":"564\/A\/22, ROAD NO.92"}]

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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DRUG PRODUCT COMPOSITIONS

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DOSAGE - TABLET;ORAL - 100MG **Federal Regist...DOSAGE - TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 20281

DOSAGE - TABLET;ORAL - 50MG **Federal Registe...DOSAGE - TABLET;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 20281

DOSAGE - TABLET;ORAL - 325MG;37.5MG

USFDA APPLICATION NUMBER - 21123

DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 100M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 21692

DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 200M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 21692

DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 300M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 21692

USFDA APPLICATION NUMBER - 21745