List of Europe Written Confirmation (EU WC) issued for VIMOVO Active Pharmaceutical Ingredient listed on PharmaCompass.com

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ACTIVE PHARMA INGREDIENTS

136 API Suppliers, 65 USDMF, 47 CEP/COS, 6 JDMF, 37 EU WC, 79 KDMF, 45 NDC API, 66 Listed Suppliers, $ API Reference Price

136 API Suppliers
65 USDMF
47 CEP/COS
6 JDMF
37 EU WC
79 KDMF
45 NDC API
66 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

4 Drugs in Development

4 Drugs in Development

INTERMEDIATES

14 Intermediates Suppliers

14 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

900 FDF Dossiers, 92 FDA Orange Book, 464 Europe, 23 Canada, 86 Australia, 62 South Africa, 173 Listed Dossiers

900 FDF Dossiers
92 FDA Orange Book
464 Europe
23 Canada
86 Australia
62 South Africa
173 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE, DELAYED RELEASE;ORAL - EQ 20MG BASE, CAPSULE, DELAYED REL PELLETS;ORAL - EQ 20MG BASE, CAPSULE, DELAYED REL PELLETS;ORAL - EQ 40MG BASE, FOR SUSPENSION, DELAYED RELEASE;ORAL - EQ 2.5MG BASE/PACKET, FOR SUSPENSION, DELAYED RELEASE;ORAL - EQ 20MG BASE/PACKET, FOR SUSPENSION, DELAYED RELEASE;ORAL - EQ 40MG BASE/PACKET, FOR SUSPENSION, DELAYED RELEASE;ORAL - EQ 5MG BASE/PACKET, TABLET, DELAYED RELEASE;ORAL - EQ 20MG BASE;375MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, DELAYED RELEASE;ORAL - EQ 20MG BASE;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

drugProductComposition
CAPSULE, DELAYED RELEASE;ORAL - EQ 20MG BASE
CAPSULE, DELAYED REL PELLETS;ORAL - EQ 20MG BASE
CAPSULE, DELAYED REL PELLETS;ORAL - EQ 40MG BASE
FOR SUSPENSION, DELAYED RELEASE;ORAL - EQ 2.5MG BASE/PACKET
FOR SUSPENSION, DELAYED RELEASE;ORAL - EQ 20MG BASE/PACKET
FOR SUSPENSION, DELAYED RELEASE;ORAL - EQ 40MG BASE/PACKET
FOR SUSPENSION, DELAYED RELEASE;ORAL - EQ 5MG BASE/PACKET
TABLET, DELAYED RELEASE;ORAL - EQ 20MG BASE;375MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, DELAYED RELEASE;ORAL - EQ 20MG BASE;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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, 3 Jai Radhe Sales, 3 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 12 Gangwal Healthcare, 4 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 4 ACG Worldwide, 6 Actylis, 1 Aeon Procare, 2 Alcedo Pharmachem, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 30 BASF, 15 Corel Pharma Chem, 3 DFE Pharma, 3 Doshion Polyscience, 2 Finar, 11 Gangwal Chemicals, 13 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 19 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 11 Microlex e.U, 2 Nanjing Bold Chemical, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 2 Novo Excipients, 3 Pharmatrans-Sanaq, 6 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 18 Roquette, 14 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 3 The Dow Chemical Company, 2 Ulanqab Kema New Material, 2 Valens Pharmachem, 3 Vasa Pharmachem, 1 Vertellus

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

EXCIPIENTS BY APPLICATIONS

70 Fillers, Diluents & Binders, 69 Coating Systems & Additives, 43 Controlled & Modified Release, 38 Direct Compression, 32 Thickeners and Stabilizers, 30 Solubilizers, 26 Taste Masking, 25 Granulation, 24 Disintegrants & Superdisintegrants, 21 Lubricants & Glidants, 19 Co-Processed Excipients, 18 Film Formers & Plasticizers, 17 Chewable & Orodispersible Aids, 16 Topical, 16 Parenteral, 9 Emulsifying Agents, 9 Empty Capsules, 6 API Stability Enhancers, 5 Coloring Agents, 4 Rheology Modifiers, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents

DIGITAL CONTENT

16 DATA COMPILATION #PharmaFlow, 152 NEWS #PharmaBuzz

media
16 DATA COMPILATION #PharmaFlow
152 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 395 Finished Drug Prices, 16 Annual Reports

globalSalesInformation
3 US Medicaid Prescriptions
395 Finished Drug Prices
16 Annual Reports

MARKET PLACE

67 APIs, 35 FDF Dossiers

marketPlace
67 APIs
35 FDF Dossiers

PATENTS & EXCLUSIVITIES

2 US Patents, 44 Health Canada Patents

patents
2 US Patents
44 Health Canada Patents

REF. STANDARDS & IMPURITIES

5 EDQM , 1 USP , 21 Others

otherSolutions
5 EDQM
1 USP
21 Others

ANALYTICAL

2 BioAnalytical Methods

otherMethods
2 BioAnalytical Methods

Esomeprazole Magnesium

Synopsis

ACTIVE PHARMA INGREDIENTS

136

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 203

MARKET PLACE

API

FDF

14INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

900

FDF Dossiers

FDA Orange Book

464

Europe

Canada

Australia

South Africa

173

Listed Dossiers

4DRUGS 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

152

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

325,992,062

Annual Reports (USD Million)

19,438

Finished Drug Prices

282 RELATED EXCIPIENT COMPANIES

505EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: Omeprazole magnesium, 161973-10-0, Prilosec otc, H 168/68 magnesium, 95382-33-5, Omeprazole (as magnesium)

Molecular Formula

C₃₄H₃₆MgN₆O₆S₂

Molecular Weight

713.1 g/mol

InChI Key

KWORUUGOSLYAGD-UHFFFAOYSA-N

FDA UNII

426QFE7XLK

The S-isomer of omeprazole.

1 2D Structure

Esomeprazole Magnesium

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

magnesium;5-methoxy-2-[(4-methoxy-3,5-dimethylpyridin-2-yl)methylsulfinyl]benzimidazol-1-ide

2.1.2 InChI

InChI=1S/2C17H18N3O3S.Mg/c2*1-10-8-18-15(11(2)16(10)23-4)9-24(21)17-19-13-6-5-12(22-3)7-14(13)20-17;/h2*5-8H,9H2,1-4H3;/q2*-1;+2

2.1.3 InChI Key

KWORUUGOSLYAGD-UHFFFAOYSA-N

2.1.4 Canonical SMILES

CC1=CN=C(C(=C1OC)C)CS(=O)C2=NC3=C([N-]2)C=CC(=C3)OC.CC1=CN=C(C(=C1OC)C)CS(=O)C2=NC3=C([N-]2)C=CC(=C3)OC.[Mg+2]

2.2 Other Identifiers

2.2.1 UNII

426QFE7XLK

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Esomeprazole

2. Esomeprazole Potassium

3. Esomeprazole Sodium

4. Esomeprazole Strontium

5. Esomeprazole Strontium Anhydrous

6. Nexium

7. Strontium, Esomeprazole

2.3.2 Depositor-Supplied Synonyms

1. Omeprazole Magnesium

2. 161973-10-0

3. Prilosec Otc

4. H 168/68 Magnesium

5. 95382-33-5

6. Omeprazole (as Magnesium)

7. 426qfe7xlk

8. Magnesium;5-methoxy-2-[(4-methoxy-3,5-dimethylpyridin-2-yl)methylsulfinyl]benzimidazol-1-ide

9. Esomeprazole Magnesium Salt

10. Unii-426qfe7xlk

11. Omeprazole Magnesium [usan]

12. Omeprazole Magnesium [usan:usp]

13. Prilosec Otc (tn)

14. Esomeprazole(magnesium)

15. Omeprazole Magnesium Salt

16. Omeprazole Magnesium (usp)

17. Mls001165732

18. Schembl722792

19. Esomeprazole Magnesium (nexium)

20. Chembl1567328

21. Chebi:94401

22. H-168/68 Magnesium

23. Hms2878h13

24. Omeprazole Magnesium [vandf]

25. Mfcd06798050

26. Omeprazole Magnesium [mart.]

27. Omeprazole Magnesium [usp-rs]

28. Omeprazole Magnesium [who-dd]

29. Akos015896379

30. Akos025402081

31. Omeprazole Magnesium Salt [mi]

32. As-75082

33. Omeprazole Magnesium [orange Book]

34. Smr000550477

35. Omeprazole Magnesium [ep Monograph]

36. Omeprazole Magnesium [usp Impurity]

37. Omeprazole Magnesium [usp Monograph]

38. Ft-0657297

39. Sw220306-1

40. Talicia Component Omeprazole Magnesium

41. D05259

42. Omeprazole Magnesium Component Of Talicia

43. A810316

44. J-014249

45. Q-100195

46. Q27166253

47. 5-methoxy-1h-1,3-benzimidazol-2-yl (4-methoxy-3,5-dimethyl-2-pyridinyl)methyl Sulfoxide

48. (rs)-5-methoxy-2-(((4-methoxy-3,5-dimethyl-2-pyridinyl)methyl)sulfinyl)-1h-benzimidazole, Magnesium Salt (2:1)

49. 5-methoxy-2-(((4-methoxy-3,5-dimethyl-2-pyridinyl)methyl)sulfinyl)-1h-benzimidazole, Magnesium Salt

50. 5-methoxy-2-(((4-methoxy-3,5-dimethyl-2-pyridyl)methyl)sulfinyl)benzimidazole, Magnesium Salt (2:1)

51. Magnesium 5-methoxy-2-[(4-methoxy-3,5-dimethyl-2-pyridyl)methylsulfinyl]benzimidazol-1-ide;esomeprazole Magnesium(random Configuration)

52. Magnesium(2+) 5-methoxy-2-[(4-methoxy-3,5-dimethylpyridin-2-yl)methanesulfinyl]-1h-1,3-benzodiazol-1-ide 6-methoxy-2-[(4-methoxy-3,5-dimethylpyridin-2-yl)methanesulfinyl]-1h-1,3-benzodiazol-1-ide

53. Magnesium, Bis(6-methoxy-2-(((4-methoxy-3,5-dimethyl-2-pyridinyl)methyl)sulfinyl-.kappa.o)-1h-benzimidazolato-.kappa.n3)-, (t-4)-

2.4 Create Date

2005-08-08

3 Chemical and Physical Properties

Molecular Formula	C₃₄H₃₆MgN₆O₆S₂
Molecular Weight	713.1 g/mol
Hydrogen Bond Donor Count	0
Hydrogen Bond Acceptor Count	14
Rotatable Bond Count	10
Exact Mass	712.1988169 g/mol
Monoisotopic Mass	712.1988169 g/mol
Topological Polar Surface Area	163 Å²
Heavy Atom Count	49
Formal Charge	0
Complexity	453
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	2
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	3

4 Drug and Medication Information

4.1 Drug Information

1 of 6
Drug Name	Esomeprazole magnesium
PubMed Health	Esomeprazole
Drug Classes	Gastric Acid Secretion Inhibitor, Gastrointestinal Agent
Drug Label	The active ingredient in NEXIUM (esomeprazole magnesium) Delayed-Release Capsules and NEXIUM (esomeprazole magnesium) For Delayed-Release Oral Suspension is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole...
Active Ingredient	Esomeprazole magnesium
Dosage Form	Capsule, delayed release
Route	oral
Strength	40mg; 20mg
Market Status	Tentative Approval
Company	Ranbaxy

2 of 6
Drug Name	Nexium
Drug Label	The active ingredient in NEXIUM (esomeprazole magnesium) Delayed-Release Capsules and NEXIUM (esomeprazole magnesium) For Delayed-Release Oral Suspension is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole...
Active Ingredient	Esomeprazole magnesium
Dosage Form	Capsule, delayed rel pellets; For suspension, delayed release
Route	Oral
Strength	eq 5mg base/packet; eq 20mg base/packet; eq 20mg base; eq 40mg base; eq 10mg base/packet; eq 40mg base/packet; eq 2.5mg base/packet
Market Status	Prescription
Company	Astrazeneca

3 of 6
Drug Name	Omeprazole magnesium
Drug Label	The active ingredient in NEXIUM (esomeprazole magnesium) Delayed-Release Capsules and NEXIUM (esomeprazole magnesium) For Delayed-Release Oral Suspension is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole...
Active Ingredient	Omeprazole magnesium
Dosage Form	Capsule, delayed release
Route	Oral
Strength	eq 20mg base
Market Status	Over the Counter
Company	Dr Reddys Labs

4 of 6
Drug Name	Esomeprazole magnesium
PubMed Health	Esomeprazole
Drug Classes	Gastric Acid Secretion Inhibitor, Gastrointestinal Agent
Drug Label	The active ingredient in NEXIUM (esomeprazole magnesium) Delayed-Release Capsules and NEXIUM (esomeprazole magnesium) For Delayed-Release Oral Suspension is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole...
Active Ingredient	Esomeprazole magnesium
Dosage Form	Capsule, delayed release
Route	oral
Strength	40mg; 20mg
Market Status	Tentative Approval
Company	Ranbaxy

5 of 6
Drug Name	Nexium
Drug Label	The active ingredient in NEXIUM (esomeprazole magnesium) Delayed-Release Capsules and NEXIUM (esomeprazole magnesium) For Delayed-Release Oral Suspension is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole...
Active Ingredient	Esomeprazole magnesium
Dosage Form	Capsule, delayed rel pellets; For suspension, delayed release
Route	Oral
Strength	eq 5mg base/packet; eq 20mg base/packet; eq 20mg base; eq 40mg base; eq 10mg base/packet; eq 40mg base/packet; eq 2.5mg base/packet
Market Status	Prescription
Company	Astrazeneca

6 of 6
Drug Name	Omeprazole magnesium
Drug Label	The active ingredient in NEXIUM (esomeprazole magnesium) Delayed-Release Capsules and NEXIUM (esomeprazole magnesium) For Delayed-Release Oral Suspension is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole...
Active Ingredient	Omeprazole magnesium
Dosage Form	Capsule, delayed release
Route	Oral
Strength	eq 20mg base
Market Status	Over the Counter
Company	Dr Reddys Labs

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Anti-Ulcer Agents

Various agents with different action mechanisms used to treat or ameliorate PEPTIC ULCER or irritation of the gastrointestinal tract. This has included ANTIBIOTICS to treat HELICOBACTER INFECTIONS; HISTAMINE H2 ANTAGONISTS to reduce GASTRIC ACID secretion; and ANTACIDS for symptomatic relief. (See all compounds classified as Anti-Ulcer Agents.)

Proton Pump Inhibitors

Compounds that inhibit H(+)-K(+)-EXCHANGING ATPASE. They are used as ANTI-ULCER AGENTS and sometimes in place of HISTAMINE H2 ANTAGONISTS for GASTROESOPHAGEAL REFLUX. (See all compounds classified as Proton Pump Inhibitors.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Proton Pump Inhibitor [EPC]; Proton Pump Inhibitors [MoA]; Cytochrome P450 2C19 Inhibitors [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 - CAPSULE, DELAYED RELEASE;ORAL - EQ 2...DOSAGE - CAPSULE, DELAYED RELEASE;ORAL - EQ 20MG BASE

USFDA APPLICATION NUMBER - 204655

DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - ...DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - EQ 20MG BASE

USFDA APPLICATION NUMBER - 21153

DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - ...DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - EQ 40MG BASE

USFDA APPLICATION NUMBER - 21153

DOSAGE - FOR SUSPENSION, DELAYED RELEASE;ORAL...DOSAGE - FOR SUSPENSION, DELAYED RELEASE;ORAL - EQ 2.5MG BASE/PACKET

USFDA APPLICATION NUMBER - 21957

DOSAGE - FOR SUSPENSION, DELAYED RELEASE;ORAL...DOSAGE - FOR SUSPENSION, DELAYED RELEASE;ORAL - EQ 20MG BASE/PACKET

USFDA APPLICATION NUMBER - 21957

DOSAGE - FOR SUSPENSION, DELAYED RELEASE;ORAL...DOSAGE - FOR SUSPENSION, DELAYED RELEASE;ORAL - EQ 40MG BASE/PACKET

USFDA APPLICATION NUMBER - 21957

DOSAGE - FOR SUSPENSION, DELAYED RELEASE;ORAL...DOSAGE - FOR SUSPENSION, DELAYED RELEASE;ORAL - EQ 5MG BASE/PACKET

USFDA APPLICATION NUMBER - 21957

DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 20...DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 20MG BASE;375MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 22511

DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 20...DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 20MG BASE;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 22511

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List of Europe Written Confirmation (EU WC) issued for VIMOVO Active Pharmaceutical Ingredient listed on PharmaCompass.com

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

136 API Suppliers

65 USDMF

47 CEP/COS

6 JDMF

37 EU WC

79 KDMF

45 NDC API

66 Listed Suppliers

$ API Reference Price

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DRUG PRODUCT COMPOSITIONS

CAPSULE, DELAYED RELEASE;ORAL - EQ 20MG BASE

CAPSULE, DELAYED REL PELLETS;ORAL - EQ 20MG BASE

CAPSULE, DELAYED REL PELLETS;ORAL - EQ 40MG BASE

FOR SUSPENSION, DELAYED RELEASE;ORAL - EQ 2.5MG BASE/PACKET

FOR SUSPENSION, DELAYED RELEASE;ORAL - EQ 20MG BASE/PACKET

FOR SUSPENSION, DELAYED RELEASE;ORAL - EQ 40MG BASE/PACKET

FOR SUSPENSION, DELAYED RELEASE;ORAL - EQ 5MG BASE/PACKET

TABLET, DELAYED RELEASE;ORAL - EQ 20MG BASE;375MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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

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TABLET, DELAYED RELEASE;ORAL - EQ 20MG BASE;375MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

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