Amoxicillin

Synopsis, Chemistry

APIs // Active Pharmaceutical Ingredients

75 API Suppliers, 44 USDMF, 30 CEP/COS, 5 JDMF, 3 EU WC, 40 KDMF, 22 NDC API, 24 Listed Suppliers

DEVELOPMENTS

22 Drug(s) in Development

22 Drug(s) in Development

PRICE INFORMATION

API Reference Price, API Exports, API Imports, FDF Exports, FDF Imports

INTERMEDIATES

2 Suppliers

2 Suppliers

DOSSIERs // Finished Dosage Formulations

1272 Dossiers, 209 FDA Orange Book, 418 Europe, 101 Canada, 70 Australia, 205 South Africa, 269 Listed Dossiers

DRUG PRODUCT COMPOSITION

TABLET;ORAL - 250MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 500MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FOR SUSPENSION;ORAL - 125MG/5ML;EQ 31.25MG BASE/5ML, FOR SUSPENSION;ORAL - 250MG/5ML;EQ 62.5MG BASE/5ML, TABLET;ORAL - 875MG;EQ 125MG BASE, FOR SUSPENSION;ORAL - 200MG/5ML;EQ 28.5MG BASE/5ML, FOR SUSPENSION;ORAL - 400MG/5ML;EQ 57MG BASE/5ML, TABLET;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FOR SUSPENSION;ORAL - 600MG/5ML;EQ 42.9MG BASE/5ML, CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL - 500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FOR SUSPENSION;ORAL - 200MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FOR SUSPENSION;ORAL - 400MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 62.5MG BASE, TABLET, EXTENDED RELEASE;ORAL - 775MG, CAPSULE, TABLET, CAPSULE, DELAYED RELEASE;ORAL - 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 250MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 500MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
FOR SUSPENSION;ORAL - 125MG/5ML;EQ 31.25MG BASE/5ML
FOR SUSPENSION;ORAL - 250MG/5ML;EQ 62.5MG BASE/5ML
TABLET;ORAL - 875MG;EQ 125MG BASE
FOR SUSPENSION;ORAL - 200MG/5ML;EQ 28.5MG BASE/5ML
FOR SUSPENSION;ORAL - 400MG/5ML;EQ 57MG BASE/5ML
TABLET;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
FOR SUSPENSION;ORAL - 600MG/5ML;EQ 42.9MG BASE/5ML
CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL - 500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
FOR SUSPENSION;ORAL - 200MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
FOR SUSPENSION;ORAL - 400MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 62.5MG BASE
TABLET, EXTENDED RELEASE;ORAL - 775MG
CAPSULE, TABLET, CAPSULE, DELAYED RELEASE;ORAL - 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

Suppliers, 15 Kerry, 11 Roquette, 10 Corel Pharma Chem, 9 Sigachi Industries, 8 BASF, 8 Microlex e.U, 6 Seppic, 6 Lonza Capsugel, 6 Gangwal Chemicals, 6 Gangwal Healthcare, 5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 5 Ideal Cures Pvt Ltd, 3 Actylis, 3 DFE Pharma, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 3 Kima Chemical, 3 Prachin Chemical, 3 Vasa Pharmachem, 2 The Dow Chemical Company, 2 Pharmatrans-Sanaq, 2 Nomisma Healthcare, 2 Seqens, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Pharm-RX Chemical, 1 Finar, 1 Ingredion Pharma Solutions, 1 Qualicaps, 1 SPI Pharma, 1 ACG Worldwide, 1 Rochem International Inc

EXCIPIENTS BY APPLICATIONS

41 Coating Systems & Additives, 24 Controlled & Modified Release, 22 Fillers, Diluents & Binders, 17 Thickeners and Stabilizers, 16 Disintegrants & Superdisintegrants, 12 Direct Compression, 12 Lubricants & Glidants, 9 Granulation, 7 Topical, 7 Film Formers & Plasticizers, 6 Co-Processed Excipients, 5 Empty Capsules, 5 API Stability Enhancers, 5 Solubilizers, 4 Vegetarian Capsules, 4 Taste Masking, 3 Emulsifying Agents, 3 Chewable & Orodispersible Aids, 2 Coloring Agents, 2 Rheology Modifiers, 2 Parenteral

GLOBAL SALES INFORMATION

12 US Medicaid Prescriptions, 393 Finished Drug Prices

MARKET PLACE

93 APIs, 44 DOSSIERS // FDF

PATENTS

13 US Patents, 6 US Exclusivities, 7 Health Canada Patents

ANALYTICAL SOLUTION(s)

3 Analytical Solutions, 3 EDQM Standards, 6 USP Standards, 22 Other Ref. Standards

DIGITAL CONTENT

9 Data Compilations & Company Tracker #PharmaFlow, 73 News

Also known as: 61336-70-7, Larotid, Polymox, Trimox, Utimox, Wymox

Molecular Formula

C₁₆H₂₅N₃O₈S

Molecular Weight

419.5 g/mol

InChI Key

MQXQVCLAUDMCEF-CWLIKTDRSA-N

FDA UNII

804826J2HU

A broad-spectrum semisynthetic antibiotic similar to AMPICILLIN except that its resistance to gastric acid permits higher serum levels with oral administration.

1 2D Structure

Amoxicillin

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

(2S,5R,6R)-6-[[(2R)-2-amino-2-(4-hydroxyphenyl)acetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid;trihydrate

2.1.2 InChI

InChI=1S/C16H19N3O5S.3H2O/c1-16(2)11(15(23)24)19-13(22)10(14(19)25-16)18-12(21)9(17)7-3-5-8(20)6-4-7;;;/h3-6,9-11,14,20H,17H2,1-2H3,(H,18,21)(H,23,24);3*1H2/t9-,10-,11+,14-;;;/m1.../s1

2.1.3 InChI Key

MQXQVCLAUDMCEF-CWLIKTDRSA-N

2.1.4 Canonical SMILES

CC1(C(N2C(S1)C(C2=O)NC(=O)C(C3=CC=C(C=C3)O)N)C(=O)O)C.O.O.O

2.1.5 Isomeric SMILES

CC1([C@@H](N2[C@H](S1)[C@@H](C2=O)NC(=O)[C@@H](C3=CC=C(C=C3)O)N)C(=O)O)C.O.O.O

2.2 Other Identifiers

2.2.1 UNII

804826J2HU

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Actimoxi

2. Amoxicillin

3. Amoxicillin Anhydrous

4. Amoxicillin Monopotassium Salt

5. Amoxicillin Monosodium Salt

6. Amoxicillin Sodium

7. Amoxicillin, (r*)-isomer

8. Amoxicilline

9. Amoxil

10. Amoxycillin

11. Brl 2333

12. Brl-2333

13. Brl2333

14. Clamoxyl

15. Clamoxyl G.a.

16. Clamoxyl Parenteral

17. Hydroxyampicillin

18. Penamox

19. Polymox

20. Trimox

21. Wymox

2.3.2 Depositor-Supplied Synonyms

1. 61336-70-7

2. Larotid

3. Polymox

4. Trimox

5. Utimox

6. Wymox

7. Clamoxyl

8. Amoxil

9. Amoxipen

10. Moxaline

11. Amodex

12. Zimox

13. Robamox

14. Dispermox

15. Novabritine

16. Hiconcil

17. Imacillin

18. Amoxycillin Trihydrate

19. Brl 2333

20. Moxatag

21. 61336-70-7 (hydrate)

22. Topramoxin

23. Amoxyke

24. Atoksilin

25. Demoksil

26. Largopen

27. Moksilin

28. Promoxil

29. Remoxil

30. Damoxy

31. 804826j2hu

32. (2s,5r,6r)-6-[[(2r)-2-amino-2-(4-hydroxyphenyl)acetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid Trihydrate

33. Amoksicillin

34. Kentrocyllin

35. Zamocilline

36. Alfamox

37. Amophar

38. Amoxidal

39. Amoxillat

40. Amoxina

41. Amoxine

42. Flemoxine

43. Galenamox

44. Gramidil

45. Himinomax

46. Izoltil

47. Matasedrin

48. Metifarma

49. Pacetocin

50. Pamocil

51. Paradroxil

52. Siganopen

53. Simplamox

54. Sintopen

55. Velamox

56. Zamocillin

57. Amoran

58. Ciblor

59. Amoxicillin Hydrate

60. Amoxi-wolff

61. Uro-clamoxyl

62. Brl-2333

63. Amoxi-diolan

64. Amox

65. Amoksicillin Forte

66. A-gram

67. Dura Ax

68. Amoxicillin [usan]

69. Amoxicillin-ratiopharm

70. Drg-0075

71. Amoxicillin (as Trihydrate)

72. (2s,5r,6r)-6-((r)-2-amino-2-(4-hydroxyphenyl)acetamido)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid Trihydrate

73. (2s,5r,6r)-6-[[(2r)-2-amino-2-(4-hydroxyphenyl)acetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid;trihydrate

74. Amoxicillin Hydrate (1:3)

75. Neotetranase

76. Sawacillin

77. Pasetocin

78. Eupen

79. Amoxil Trihydrate

80. Unii-804826j2hu

81. Alpha-amino-p-hydroxybenzylpenicillin Trihydrate

82. Amoxipen Trihydrate

83. Dispermox (tn)

84. Moxaline Trihydrate

85. Pasetocin (tn)

86. (2s,5r,6r)-6-{[(2r)-2-amino-2-(4-hydroxyphenyl)acetyl]amino}-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid Trihydrate

87. Amoxicillin (usp)

88. Amoxicillin Pulsys

89. Amoxicillin-trihydrat

90. Amoxicilline (inn)

91. Amoxil (tn)

92. Amoxicillin [usan:usp:inn:ban:jan]

93. (2s,5r,6r)-6-[(2r)-2-amino-2-(4-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid

94. Amoxicillin [vandf]

95. Amoxicillin Hydrate (jp17)

96. Amoxicillin [usp-rs]

97. (2s,5r,6r)-6-((r)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylic Acid Trihydrate

98. Dtxsid2022599

99. Chebi:51254

100. Amoxicillin [orange Book]

101. Amoxicillin Hydrate [jan]

102. Apc-111

103. Amoxicillin [usp Impurity]

104. Amoxicillin [usp Monograph]

105. Amoxicillin Trihydrate [mi]

106. Prevpac Component Amoxicillin

107. Talicia Component Amoxicillin

108. Mfcd00072029

109. S5298

110. Amoxicillin Trihydrate [vandf]

111. Augmentin Component Amoxicillin

112. Akos015896673

113. Amoxicillin Trihydrate [mart.]

114. Amoxicillin Component Of Prevpac

115. Amoxicillin Component Of Talicia

116. Amoxicillin Trihydrate [who-dd]

117. Amoxicillin Trihydrate [who-ip]

118. Ccg-268878

119. Ks-5338

120. Amoxicillin Component Of Augmentin

121. 4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylic Acid, 6-((amino(4-hydroxyphenyl)acetyl)amino)-3,3-dimethyl-7-oxo-, Trihydrate (2s-(2alpha,5alpha,6beta(s*)))-

122. 4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylic Acid, 6-((amino(4-hydroxyphenyl)acetyl)amino)-3,3-dimethyl-7-oxo-, Trihydrate(2s-(2alpha,5alpha,6beta(s*)))-

123. Amoxicillin Trihydrate [green Book]

124. Amoxicillin Trihydrate [ep Monograph]

125. Clavulox Component Amoxicillin Trihydrate

126. D00229

127. Amoxicillinum Trihydricum [who-ip Latin]

128. A833170

129. Amoxicillin Trihydrate Component Of Clavulox

130. Q27122483

131. Amoxil Trihydrate;amoxipen Trihydrate;moxaline Trihydrate

132. Amoxicillin Trihydrate, Vetranal(tm), Analytical Standard

133. Amoxicillin, United States Pharmacopeia (usp) Reference Standard

134. Amoxicillin Trihydrate, British Pharmacopoeia (bp) Reference Standard

135. Amoxicillin Trihydrate, European Pharmacopoeia (ep) Reference Standard

136. Amoxicillin Trihydrate, Pharmaceutical Secondary Standard; Certified Reference Material

137. (2s,5r)-6-[[2-amino-2-(4-hydroxyphenyl)acetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid Trihydrate

138. (2s,5r,6r)-6-((r)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido)-3,3-dimethyl-7-oxo-4-thia-1-azabicycl(3.2.0)heptane-2-carboxylic Acid Trihydrate

139. 4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylic Acid, 6-(((2r)-amino(4-hydroxyphenyl)acetyl)amino)-3,3-dimethyl-7-oxo-, Trihydrate, (2s,5r,6r)-

140. 4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylic Acid, 6-((amino(4-hydroxyphenyl)acetyl)amino)-3,3-dimethyl-7-oxo-, Trihydrate(2s-(2.alpha.,5.alpha.,6.beta.(s*)))-

141. 6beta-[(2r)-2-amino-2-(4-hydroxyphenyl)acetamido]-2,2-dimethylpenam-3alpha-carboxylic Acid Trihydrate

142. Amoxicillin Trihydrate For Performance Verification, European Pharmacopoeia (ep) Reference Standard

2.4 Create Date

2005-08-08

3 Chemical and Physical Properties

Molecular Formula	C₁₆H₂₅N₃O₈S
Molecular Weight	419.5 g/mol
Hydrogen Bond Donor Count	7
Hydrogen Bond Acceptor Count	10
Rotatable Bond Count	4
Exact Mass	419.13623594 g/mol
Monoisotopic Mass	419.13623594 g/mol
Topological Polar Surface Area	161 Å²
Heavy Atom Count	28
Formal Charge	0
Complexity	590
Isotope Atom Count	0
Defined Atom Stereocenter Count	4
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	4

4 Drug and Medication Information

4.1 Drug Information

1 of 6
Drug Name	Amoxil
Active Ingredient	Amoxicillin
Dosage Form	Tablet; Capsule; Tablet, chewable; For suspension
Route	Oral
Strength	875mg; 50mg/ml; 200mg/5ml; 250mg; 125mg/5ml; 400mg/5ml; 125mg; 500mg; 250mg/5ml
Market Status	Prescription
Company	Dr Reddys Labs

2 of 6
Drug Name	Larotid
PubMed Health	Amoxicillin (By mouth)
Drug Classes	Antibiotic
Drug Label	MOXATAG (amoxicillin extended-release) tablets for oral administration are provided as blue film-coated, oval shaped tablets that contain 775 mg of amoxicillin as the trihydrate and are printed with MB-111 on one side in black edible ink. Amoxi...
Active Ingredient	Amoxicillin
Dosage Form	For suspension
Route	Oral
Strength	250mg/5ml; 125mg/5ml
Market Status	Prescription
Company	Dr Reddys Labs

3 of 6
Drug Name	Moxatag
Active Ingredient	Amoxicillin
Dosage Form	Tablet, extended release
Route	Oral
Strength	775mg
Market Status	Prescription
Company	Pragma Pharms

4 of 6
Drug Name	Amoxil
Active Ingredient	Amoxicillin
Dosage Form	Tablet; Capsule; Tablet, chewable; For suspension
Route	Oral
Strength	875mg; 50mg/ml; 200mg/5ml; 250mg; 125mg/5ml; 400mg/5ml; 125mg; 500mg; 250mg/5ml
Market Status	Prescription
Company	Dr Reddys Labs

5 of 6
Drug Name	Larotid
PubMed Health	Amoxicillin (By mouth)
Drug Classes	Antibiotic
Drug Label	MOXATAG (amoxicillin extended-release) tablets for oral administration are provided as blue film-coated, oval shaped tablets that contain 775 mg of amoxicillin as the trihydrate and are printed with MB-111 on one side in black edible ink. Amoxi...
Active Ingredient	Amoxicillin
Dosage Form	For suspension
Route	Oral
Strength	250mg/5ml; 125mg/5ml
Market Status	Prescription
Company	Dr Reddys Labs

6 of 6
Drug Name	Moxatag
Active Ingredient	Amoxicillin
Dosage Form	Tablet, extended release
Route	Oral
Strength	775mg
Market Status	Prescription
Company	Pragma Pharms

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Anti-Bacterial Agents

Substances that inhibit the growth or reproduction of BACTERIA. (See all compounds classified as Anti-Bacterial Agents.)

Find Amoxicillin Trihydrate manufacturers, exporters & distributors on PharmaCompass

Amoxicillin

Amoxicillin

Synopsis

Chemistry

APIs // Active Pharmaceutical Ingredients

75 API Suppliers

44 USDMF

30 CEP/COS

5 JDMF

3 EU WC

40 KDMF

22 NDC API

24 Listed Suppliers

DEVELOPMENTS

22 Drug(s) in Development

PRICE INFORMATION

API Reference Price

API Exports

API Imports

FDF Exports

FDF Imports

INTERMEDIATES

2 Suppliers

DOSSIERs // Finished Dosage Formulations

1272 Dossiers

209 FDA Orange Book

418 Europe

101 Canada

70 Australia

205 South Africa

269 Listed Dossiers

DRUG PRODUCT COMPOSITION

TABLET;ORAL - 250MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 500MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

FOR SUSPENSION;ORAL - 125MG/5ML;EQ 31.25MG BASE/5ML

FOR SUSPENSION;ORAL - 250MG/5ML;EQ 62.5MG BASE/5ML

TABLET;ORAL - 875MG;EQ 125MG BASE

FOR SUSPENSION;ORAL - 200MG/5ML;EQ 28.5MG BASE/5ML

FOR SUSPENSION;ORAL - 400MG/5ML;EQ 57MG BASE/5ML

TABLET;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

FOR SUSPENSION;ORAL - 600MG/5ML;EQ 42.9MG BASE/5ML

CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL - 500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

FOR SUSPENSION;ORAL - 200MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

FOR SUSPENSION;ORAL - 400MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 62.5MG BASE

TABLET, EXTENDED RELEASE;ORAL - 775MG

CAPSULE, TABLET, CAPSULE, DELAYED RELEASE;ORAL - 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

Suppliers

15 Kerry

11 Roquette

10 Corel Pharma Chem

9 Sigachi Industries

8 BASF

8 Microlex e.U

6 Seppic

6 Lonza Capsugel

6 Gangwal Chemicals

6 Gangwal Healthcare

5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

5 Ideal Cures Pvt Ltd

3 Actylis

3 DFE Pharma

3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

3 Kima Chemical

3 Prachin Chemical

3 Vasa Pharmachem

2 The Dow Chemical Company

2 Pharmatrans-Sanaq

2 Nomisma Healthcare

2 Seqens

1 Qianhao Chemical (Hebei) Co., Ltd

1 Pharm-RX Chemical

1 Finar

1 Ingredion Pharma Solutions

1 Qualicaps

1 SPI Pharma

1 ACG Worldwide

TABLET;ORAL - 250MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 500MG;EQ 125MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 875MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL - 500MG;500MG;30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

FOR SUSPENSION;ORAL - 200MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

FOR SUSPENSION;ORAL - 400MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

CAPSULE, TABLET, CAPSULE, DELAYED RELEASE;ORAL - 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons