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ACTIVE PHARMA INGREDIENTS

38 API Suppliers, 13 USDMF, 1 CEP/COS, 6 JDMF, 4 EU WC, 7 NDC API, 25 Listed Suppliers, $ API Reference Price

38 API Suppliers
13 USDMF
1 CEP/COS
6 JDMF
4 EU WC
7 NDC API
25 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

INTERMEDIATES

5 Intermediates Suppliers

5 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

123 FDF Dossiers, 63 FDA Orange Book, 30 Europe, 8 Canada, 8 Australia, 4 South Africa, 10 Listed Dossiers

123 FDF Dossiers
63 FDA Orange Book
30 Europe
8 Canada
8 Australia
4 South Africa
10 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE, EXTENDED RELEASE;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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CAPSULE, EXTENDED RELEASE;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
CAPSULE, EXTENDED RELEASE;ORAL - 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem, 2 Evonik, 1 Rochem International Inc, 17 SPI Pharma, 2 Seqens, 8 DKSH, 2 Jai Radhe Sales, 5 Faran Shimi Pharmaceutical, 1 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 12 Gangwal Healthcare, 4 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 4 ACG Worldwide, 6 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 26 BASF, 1 Clariant, 17 Corel Pharma Chem, 3 DFE Pharma, 2 Finar, 10 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 17 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 11 Microlex e.U, 1 Nanjing Bold Chemical, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 2 Novo Excipients, 4 Pharmatrans-Sanaq, 5 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 20 Roquette, 14 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 3 The Dow Chemical Company, 1 Valens Pharmachem, 3 Vasa Pharmachem, 2 Vertellus

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

EXCIPIENTS BY APPLICATIONS

68 Fillers, Diluents & Binders, 53 Coating Systems & Additives, 41 Controlled & Modified Release, 36 Direct Compression, 31 Thickeners and Stabilizers, 25 Solubilizers, 24 Disintegrants & Superdisintegrants, 23 Granulation, 22 Lubricants & Glidants, 21 Taste Masking, 18 Film Formers & Plasticizers, 17 Chewable & Orodispersible Aids, 17 Co-Processed Excipients, 16 Parenteral, 15 Topical, 9 Empty Capsules, 8 Emulsifying Agents, 6 API Stability Enhancers, 5 Surfactant & Foaming Agents, 5 Coloring Agents, 4 Rheology Modifiers, 4 Vegetarian Capsules

DIGITAL CONTENT

15 NEWS #PharmaBuzz

media
15 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 36 Finished Drug Prices

globalSalesInformation
1 US Medicaid Prescriptions
36 Finished Drug Prices

MARKET PLACE

15 APIs, 1 Intermediates

marketPlace
15 APIs
1 Intermediates

REF. STANDARDS & IMPURITIES

1 EDQM , 1 USP , 4 JP , 1 Others

otherSolutions
1 EDQM
1 USP
4 JP
1 Others

ANALYTICAL

1 BioAnalytical Methods

otherMethods
1 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)

$ 422

MARKET PLACE

API

FDF

5INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

123

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

1DRUGS 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)

19,797,462

Annual Reports (USD Million)

Finished Drug Prices

264 RELATED EXCIPIENT COMPANIES

468EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: Luvox, 61718-82-9, Fevarin, Faverin, Luvox cr, Du23000

Molecular Formula

C₁₉H₂₅F₃N₂O₆

Molecular Weight

434.4 g/mol

InChI Key

LFMYNZPAVPMEGP-PIDGMYBPSA-N

FDA UNII

5LGN83G74V

A selective serotonin reuptake inhibitor that is used in the treatment of DEPRESSION and a variety of ANXIETY DISORDERS.

1 2D Structure

Fluvoxamine

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

(Z)-but-2-enedioic acid;2-[(E)-[5-methoxy-1-[4-(trifluoromethyl)phenyl]pentylidene]amino]oxyethanamine

2.1.2 InChI

InChI=1S/C15H21F3N2O2.C4H4O4/c1-21-10-3-2-4-14(20-22-11-9-19)12-5-7-13(8-6-12)15(16,17)18;5-3(6)1-2-4(7)8/h5-8H,2-4,9-11,19H2,1H3;1-2H,(H,5,6)(H,7,8)/b20-14+;2-1-

2.1.3 InChI Key

LFMYNZPAVPMEGP-PIDGMYBPSA-N

2.1.4 Canonical SMILES

COCCCCC(=NOCCN)C1=CC=C(C=C1)C(F)(F)F.C(=CC(=O)O)C(=O)O

2.1.5 Isomeric SMILES

COCCCC/C(=N\OCCN)/C1=CC=C(C=C1)C(F)(F)F.C(=C\C(=O)O)\C(=O)O

2.2 Other Identifiers

2.2.1 UNII

5LGN83G74V

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Desiflu

2. Du 23000

3. Du-23000

4. Du23000

5. Dumirox

6. Faverin

7. Fevarin

8. Floxyfral

9. Fluvoxadura

10. Fluvoxamin Al

11. Fluvoxamin Beta

12. Fluvoxamin Neuraxpharm

13. Fluvoxamin Ratiopharm

14. Fluvoxamin Stada

15. Fluvoxamin-neuraxpharm

16. Fluvoxamin-ratiopharm

17. Fluvoxamina Geminis

18. Fluvoxamine

19. Fluvoxamine Maleate, (e)-isomer

20. Fluvoxamine, (z)-isomer

21. Geminis, Fluvoxamina

22. Luvox

23. Novo Fluvoxamine

24. Novo-fluvoxamine

25. Nu Fluvoxamine

26. Nu-fluvoxamine

27. Pms Fluvoxamine

28. Pms-fluvoxamine

29. Ratio Fluvoxamine

30. Ratio-fluvoxamine

2.3.2 Depositor-Supplied Synonyms

1. Luvox

2. 61718-82-9

3. Fevarin

4. Faverin

5. Luvox Cr

6. Du23000

7. Fluvoxamine (maleate)

8. Du-23000

9. Fluvoxamine Hydrogenmaleate

10. 54739-20-7

11. Nsc-759602

12. 5lgn83g74v

13. (z)-but-2-enedioic Acid;2-[(e)-[5-methoxy-1-[4-(trifluoromethyl)phenyl]pentylidene]amino]oxyethanamine

14. 1-pentanone, 5-methoxy-1-(4-(trifluoromethyl)phenyl)-, O-(2-aminoethyl)oxime, (e)-, (z)-2-butenedioate (1:1)

15. Fluvoxaminemaleate

16. Floxyfral

17. (e)-5-methoxy-1-(4-(trifluoromethyl)phenyl)pentan-1-one O-(2-aminoethyl) Oxime Maleate

18. Mk-264

19. (e)-5-methoxy-1-[4-(trifluoromethyl)phenyl]-1-pentanone-o-(2-aminoethyl)oxime Maleate

20. Fluvoxamine Maleate [usan]

21. (2z)-but-2-enedioic Acid; (e)-(2-aminoethoxy)({5-methoxy-1-[4-(trifluoromethyl)phenyl]pentylidene})amine

22. Smr000466268

23. Smr000653482

24. Sr-01000075613

25. Sme 3110

26. Unii-5lgn83g74v

27. Depromel

28. Fluvoxamine Maleate [usan:usp]

29. Luvox (tn)

30. Nsc 309469

31. Fluvoxamine Maleate, Solid

32. 5-methoxy-4'-trifluoromethylvalerophenone (e)-o-2-aminoethyloxime Monomaleate

33. Fluvoxamine Maleate- Bio-x

34. 5-methoxy-4'-(trifluoromethyl)valerophenone (e)-o-(2-aminoethyl)oxime, Maleate (1:1)

35. Chembl1409

36. Schembl35225

37. Mls000028469

38. Mls000758271

39. Mls001076285

40. Mls001304717

41. Mls001401391

42. Chebi:5139

43. Dtxsid3042558

44. Fluvoxamine Maleate [mi]

45. Hy-b0103a

46. Fluvoxamine Maleate [jan]

47. Fluvoxamine Maleate (jp17/usp)

48. Hms1571g11

49. Hms2098g11

50. Hms3261d11

51. Hms3412a13

52. Hms3676a13

53. Hms3715g11

54. Hms3884k11

55. Pharmakon1600-01505604

56. Fluvoxamine Maleate [vandf]

57. (2-aminoethoxy)({5-methoxy-1-[4-(trifluoromethyl)phenyl]pentylidene})amine; But-2-enedioic Acid

58. Fluvoxamine Maleate [mart.]

59. Sme-3110

60. Tox21_500495

61. Fluvoxamine Maleate [usp-rs]

62. Fluvoxamine Maleate [who-dd]

63. Mfcd00269809

64. Nsc309469

65. Nsc759602

66. S1336

67. Akos015961142

68. Ac-9541

69. Ccg-213494

70. Cs-1839

71. Nsc 759602

72. Nsc-309469

73. Fluvoxamine Maleate [orange Book]

74. Ncgc00093897-01

75. Ncgc00093897-02

76. Ncgc00261180-01

77. (e)-5-methoxy-1-(4-(trifluoromethyl)phenyl)-1-pentanone O-(2-aminoethyl)oxime (z)-2-butenedioate (1:1)

78. As-11790

79. Bf164482

80. Fluvoxamine Maleate [ep Monograph]

81. Smr000058449

82. Fluvoxamine Maleate [usp Monograph]

83. Eu-0100495

84. F0858

85. D00824

86. F 2802

87. 739f183

88. A833394

89. Sr-01000075613-1

90. Sr-01000075613-3

91. Sr-01000075613-4

92. Sr-01000075613-6

93. Fluvoxamine Maleate, British Pharmacopoeia (bp) Reference Standard

94. Fluvoxamine Maleate, European Pharmacopoeia (ep) Reference Standard

95. Fluvoxamine Maleate, United States Pharmacopeia (usp) Reference Standard

96. (e)-5-methoxy-1-[4-(trifluoromethyl)phenyl]-1-pentanone O-(2-aminoethyl)oxime Maleate

97. 5-methoxy-1-(4-trifluoromethyl-phenyl)-pentan-1-one O-(2-amino-ethyl)-oxime Maleate

98. Fluvoxamine For System Suitability, European Pharmacopoeia (ep) Reference Standard

99. Fluvoxamine Maleate, 1.0 Mg/ml In Methanol ((as Free Base)), Certified Reference Material

100. Fluvoxamine Maleate, Pharmaceutical Secondary Standard; Certified Reference Material

101. (z)-2-butenedioic Acid; 2-[(e)-[5-methoxy-1-[4-(trifluoromethyl)phenyl]pentylidene]amino]oxyethanamine

102. (z)-but-2-enedioic Acid; 2-[(e)-[5-methoxy-1-[4-(trifluoromethyl)phenyl]pentylidene]amino]oxyethanamine

103. 1-pentanone, 5-methoxy-1-[4-(trifluoromethyl)phenyl]-,o-(2-aminoethyl)oxime, (1e)-, (2z)-2-butenedioate (1:1)

104. 2-[({(1e)-5-methoxy-1-[4-(trifluoromethyl)phenyl]pentylidene}amino)oxy]ethanamine (2z)-but-2-enedioate

105. 5-methoxy-4'-(trifluoromethyl)valerophenone-(e)-o-(2-aminoethyl)oxime Maleate (1:1)

2.4 Create Date

2006-10-23

3 Chemical and Physical Properties

Molecular Formula	C₁₉H₂₅F₃N₂O₆
Molecular Weight	434.4 g/mol
Hydrogen Bond Donor Count	3
Hydrogen Bond Acceptor Count	11
Rotatable Bond Count	11
Exact Mass	434.16647101 g/mol
Monoisotopic Mass	434.16647101 g/mol
Topological Polar Surface Area	131 Å²
Heavy Atom Count	30
Formal Charge	0
Complexity	446
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	2
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

4 Drug and Medication Information

4.1 Drug Information

1 of 6
Drug Name	Fluvoxamine maleate
PubMed Health	Fluvoxamine (By mouth)
Drug Classes	Antidepressant, Central Nervous System Agent
Drug Label	Fluvoxamine maleate is a selective serotonin (5-HT) reuptake inhibitor (SSRI) belonging to a new chemical series, the 2-aminoethyl oxime ethers of aralkylketones. It is chemically unrelated to other SSRIs and clomipramine. It is chemically designated...
Active Ingredient	Fluvoxamine maleate
Dosage Form	Tablet; Capsule, extended release
Route	Oral
Strength	25mg; 150mg; 100mg; 50mg
Market Status	Prescription
Company	Anchen Pharms; Teva; Apotex; Sandoz; Actavis Elizabeth; Mylan; Barr

2 of 6
Drug Name	Luvox
PubMed Health	Fluvoxamine (By mouth)
Drug Classes	Antidepressant, Central Nervous System Agent
Drug Label	Fluvoxamine maleate is a selective serotonin (5-HT) reuptake inhibitor (SSRI) belonging to a new chemical series, the 2-aminoethyl oxime ethers of aralkylketones. It is chemically unrelated to other SSRIs and clomipramine. It is chemically designated...
Active Ingredient	Fluvoxamine maleate
Dosage Form	Tablet
Route	oral; Oral
Strength	25mg; 100mg; 50mg
Market Status	Prescription
Company	Ani Pharms; Jazz

3 of 6
Drug Name	Luvox cr
Drug Label	LUVOX CR is an extended-release capsule for oral administration that contains fluvoxamine maleate, a selective serotonin (5-HT) reuptake inhibitor (SSRI) belonging to the chemical series, the 2-aminoethyl oxime ethers of aralkylketones....
Active Ingredient	Fluvoxamine maleate
Dosage Form	Capsule, extended release
Route	Oral
Strength	150mg; 100mg
Market Status	Prescription
Company	Jazz Pharms

4 of 6
Drug Name	Fluvoxamine maleate
PubMed Health	Fluvoxamine (By mouth)
Drug Classes	Antidepressant, Central Nervous System Agent
Drug Label	Fluvoxamine maleate is a selective serotonin (5-HT) reuptake inhibitor (SSRI) belonging to a new chemical series, the 2-aminoethyl oxime ethers of aralkylketones. It is chemically unrelated to other SSRIs and clomipramine. It is chemically designated...
Active Ingredient	Fluvoxamine maleate
Dosage Form	Tablet; Capsule, extended release
Route	Oral
Strength	25mg; 150mg; 100mg; 50mg
Market Status	Prescription
Company	Anchen Pharms; Teva; Apotex; Sandoz; Actavis Elizabeth; Mylan; Barr

5 of 6
Drug Name	Luvox
PubMed Health	Fluvoxamine (By mouth)
Drug Classes	Antidepressant, Central Nervous System Agent
Drug Label	Fluvoxamine maleate is a selective serotonin (5-HT) reuptake inhibitor (SSRI) belonging to a new chemical series, the 2-aminoethyl oxime ethers of aralkylketones. It is chemically unrelated to other SSRIs and clomipramine. It is chemically designated...
Active Ingredient	Fluvoxamine maleate
Dosage Form	Tablet
Route	oral; Oral
Strength	25mg; 100mg; 50mg
Market Status	Prescription
Company	Ani Pharms; Jazz

6 of 6
Drug Name	Luvox cr
Drug Label	LUVOX CR is an extended-release capsule for oral administration that contains fluvoxamine maleate, a selective serotonin (5-HT) reuptake inhibitor (SSRI) belonging to the chemical series, the 2-aminoethyl oxime ethers of aralkylketones....
Active Ingredient	Fluvoxamine maleate
Dosage Form	Capsule, extended release
Route	Oral
Strength	150mg; 100mg
Market Status	Prescription
Company	Jazz Pharms

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Anti-Anxiety Agents

Agents that alleviate ANXIETY, tension, and ANXIETY DISORDERS, promote sedation, and have a calming effect without affecting clarity of consciousness or neurologic conditions. ADRENERGIC BETA-ANTAGONISTS are commonly used in the symptomatic treatment of anxiety but are not included here. (See all compounds classified as Anti-Anxiety Agents.)

Antidepressive Agents, Second-Generation

A structurally and mechanistically diverse group of drugs that are not tricyclics or monoamine oxidase inhibitors. The most clinically important appear to act selectively on serotonergic systems, especially by inhibiting serotonin reuptake. (See all compounds classified as Antidepressive Agents, Second-Generation.)

Cytochrome P-450 CYP1A2 Inhibitors

Drugs and compounds which inhibit or antagonize the biosynthesis or actions of CYTOCHROME P-450 CYP1A2. (See all compounds classified as Cytochrome P-450 CYP1A2 Inhibitors.)

Cytochrome P-450 CYP2C19 Inhibitors

Drugs and compounds which inhibit or antagonize the biosynthesis or actions of CYTOCHROME P-450 CYP2C19. (See all compounds classified as Cytochrome P-450 CYP2C19 Inhibitors.)

Selective Serotonin Reuptake Inhibitors

Compounds that specifically inhibit the reuptake of serotonin in the brain. (See all compounds classified as Selective Serotonin Reuptake Inhibitors.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Serotonin Uptake Inhibitors [MoA]; Serotonin Reuptake Inhibitor [EPC]

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API Reference Price

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TAINAN CITY 70042 ., , TAIWAN TAIWAN","customerAddress":"5TH FLOOR,LAXMINARAYAN COMPLEX"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1720549800,"product":"FLUVOXAMINE MALEATE USP BATCH NO : 610513","address":"OLD NO.1\/63, NEW NO.1\/58 PUDUPAKKAM","city":"","supplier":"ENDO OPERATIONS (GX\/SI SUPPLY)","supplierCountry":"UNITED STATES","foreign_port":"LOS ANGELES","customer":"PAR PHARMACEUTICAL","customerCountry":"INDIA","quantity":"334.00","actualQuantity":"334","unit":"KGS","unitRateFc":"480","totalValueFC":"162507.8","currency":"USD","unitRateINR":"40671.3","date":"10-Jul-2024","totalValueINR":"13584204.75","totalValueInUsd":"162507.8","indian_port":"Madras Air","hs_no":"29349990","bill_no":"4425884","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"LOS ANGELES","supplierAddress":"1ST FLOOR MINERVA HOUSESIM MONS COURTS ROADBALLS BRIDGE, DUBLIN 4 IRELAND","customerAddress":"OLD NO.1\/63, NEW NO.1\/58 PUDUPAKKAM"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1721586600,"product":"FLUVOXAMINE MALEATE USP (RE-IMP)(EXP VIDE SB NO.7807100\/28.01.2022)","address":"TYPE-C,PLOT NO.10,ROAD NO.8","city":"HYD-A.P.","supplier":"APOTEX INC","supplierCountry":"INDIA","foreign_port":"TORONTO","customer":"SRINI PHARMACEUTICALS","customerCountry":"INDIA","quantity":"106.22","actualQuantity":"106.22","unit":"KGS","unitRateFc":"475","totalValueFC":"51884.6","currency":"USD","unitRateINR":"40831.2","date":"22-Jul-2024","totalValueINR":"4337090.59","totalValueInUsd":"51884.6","indian_port":"Hyderabad Air","hs_no":"29280090","bill_no":"4643523","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"TORONTO","supplierAddress":"50 STEINWAY DRIVE ETOBICOKE-ONTARIOCANADA MSW 6Y3SDNF Canada","customerAddress":"TYPE-C,PLOT NO.10,ROAD NO.8"}]

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

USFDA APPLICATION NUMBER - 22033

DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 150...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 22033

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

CAPSULE, EXTENDED RELEASE;ORAL - 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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CAPSULE, EXTENDED RELEASE;ORAL - 100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

CAPSULE, EXTENDED RELEASE;ORAL - 150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons