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ACTIVE PHARMA INGREDIENTS

75 API Suppliers, 24 USDMF, 21 CEP/COS, 5 JDMF, 17 EU WC, 15 KDMF, 18 NDC API, 46 Listed Suppliers, $ API Reference Price

75 API Suppliers
24 USDMF
21 CEP/COS
5 JDMF
17 EU WC
15 KDMF
18 NDC API
46 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

INTERMEDIATES

4 Intermediates Suppliers

4 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

91 FDF Dossiers, 28 FDA Orange Book, 28 Europe, 16 Canada, 2 South Africa, 17 Listed Dossiers

91 FDF Dossiers
28 FDA Orange Book
28 Europe
16 Canada
2 South Africa
17 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INTRAVENOUS - 400MG/250ML (1.6MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION/DROPS;OPHTHALMIC - EQ 0.5% BASE

drugProductComposition
TABLET;ORAL - EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
SOLUTION;INTRAVENOUS - 400MG/250ML (1.6MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
SOLUTION/DROPS;OPHTHALMIC - EQ 0.5% BASE

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

EXCIPIENTS BY APPLICATIONS

74 Fillers, Diluents & Binders, 54 Coating Systems & Additives, 33 Direct Compression, 32 Disintegrants & Superdisintegrants, 29 Controlled & Modified Release, 27 Thickeners and Stabilizers, 22 Lubricants & Glidants, 22 Film Formers & Plasticizers, 22 Solubilizers, 18 Parenteral, 17 Co-Processed Excipients, 17 Granulation, 17 Topical, 12 Taste Masking, 10 Chewable & Orodispersible Aids, 9 Emulsifying Agents, 8 API Stability Enhancers, 7 Rheology Modifiers, 5 Empty Capsules, 5 Coloring Agents, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 1 Soft Gelatin

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 18 NEWS #PharmaBuzz

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1 DATA COMPILATION #PharmaFlow
18 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 18 Finished Drug Prices, 4 Annual Reports

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3 US Medicaid Prescriptions
18 Finished Drug Prices
4 Annual Reports

MARKET PLACE

28 APIs, 1 FDF Dossiers

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28 APIs
1 FDF Dossiers

PATENTS & EXCLUSIVITIES

2 US Patents, 18 Health Canada Patents

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2 US Patents
18 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM , 1 USP , 3 Others

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1 USP
3 Others

ANALYTICAL

1 BioAnalytical Methods

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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)

$ 383

MARKET PLACE

API

FDF

4INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

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)

3,263,466

Annual Reports (USD Million)

1,195

Finished Drug Prices

266 RELATED EXCIPIENT COMPANIES

449EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 186826-86-8, Moxifloxacin hcl, Avelox, Avalox, Vigamox, Moxifloxacin (hydrochloride)

Molecular Formula

C₂₁H₂₅ClFN₃O₄

Molecular Weight

437.9 g/mol

InChI Key

IDIIJJHBXUESQI-DFIJPDEKSA-N

FDA UNII

C53598599T

A fluoroquinolone that acts as an inhibitor of DNA TOPOISOMERASE II and is used as a broad-spectrum antibacterial agent.

1 2D Structure

Moxifloxacin Hydrochloride

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

7-[(4aS,7aS)-1,2,3,4,4a,5,7,7a-octahydropyrrolo[3,4-b]pyridin-6-yl]-1-cyclopropyl-6-fluoro-8-methoxy-4-oxoquinoline-3-carboxylic acid;hydrochloride

2.1.2 InChI

InChI=1S/C21H24FN3O4.ClH/c1-29-20-17-13(19(26)14(21(27)28)9-25(17)12-4-5-12)7-15(22)18(20)24-8-11-3-2-6-23-16(11)10-24;/h7,9,11-12,16,23H,2-6,8,10H2,1H3,(H,27,28);1H/t11-,16+;/m0./s1

2.1.3 InChI Key

IDIIJJHBXUESQI-DFIJPDEKSA-N

2.1.4 Canonical SMILES

COC1=C2C(=CC(=C1N3CC4CCCNC4C3)F)C(=O)C(=CN2C5CC5)C(=O)O.Cl

2.1.5 Isomeric SMILES

COC1=C2C(=CC(=C1N3C[C@@H]4CCCN[C@@H]4C3)F)C(=O)C(=CN2C5CC5)C(=O)O.Cl

2.2 Other Identifiers

2.2.1 UNII

C53598599T

2.3 Synonyms

2.3.1 MeSH Synonyms

1. 1-cyclopropyl--7-(2,8-diazabicyclo(4.3.0)non-8-yl)-6-fluoro-8-methoxy-1,4-dihydro-4-oxo-3-quinolinecarboxylic Acid

2. Actira

3. Avalox

4. Avelox

5. Bay 12 8039

6. Bay 12-8039

7. Bay 128039

8. Bay-12-8039

9. Bay-128039

10. Bay128039

11. Izilox

12. Moxifloxacin

13. Octegra

14. Proflox

2.3.2 Depositor-Supplied Synonyms

1. 186826-86-8

2. Moxifloxacin Hcl

3. Avelox

4. Avalox

5. Vigamox

6. Moxifloxacin (hydrochloride)

7. Bay 12-8039

8. Bay-12-8039

9. Actira

10. Izilox

11. Moxifloxacine Hydrochloride

12. Chebi:7008

13. Moxifloxacin (as Hydrochloride)

14. Bay12-8039 Hcl

15. Moxeza

16. Al-15469a

17. Nsc-758875

18. (4as-cis)-1-cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-(octahydro-6h-pyrrolol(3,4-b)pyridin-6-yl)-4-oxo-3-quinolinecarboxylic Acid, Monohydrochloride

19. 1-cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-((4as,7as)-octahydro-6h-pyrrolo(3,4-b)pyridin-6-yl)-4-oxo-3-quinolinecarboxylic Acid, Monohydrochloride

20. C53598599t

21. Bay-128039

22. Dsstox_cid_25921

23. Dsstox_rid_81224

24. Dsstox_gsid_45921

25. 7-[(4as,7as)-1,2,3,4,4a,5,7,7a-octahydropyrrolo[3,4-b]pyridin-6-yl]-1-cyclopropyl-6-fluoro-8-methoxy-4-oxoquinoline-3-carboxylic Acid Hydrochloride

26. 7-[(4as,7as)-octahydro-1h-pyrrolo[3,4-b]pyridin-6-yl]-1-cyclopropyl-6-fluoro-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic Acid Hydrochloride

27. 186826-86-8 (hcl); 354812-41-2 (free Base)

28. Octegra

29. Vigamox (tn)

30. Avelox (tn)

31. Mflx

32. 1-cyclopropyl-6-fluoro-7-((4as,7as)-hexahydro-1h-pyrrolo[3,4-b]pyridin-6(2h)-yl)-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic Acid Hydrochloride

33. 1-cyclopropyl-6-fluoro-8-methoxy-4-oxo-7-((4as,7as)-tetrahydro-1h-pyrrolo[3,4-b]pyridin-6(2h,7h,7ah)-yl)-1,4-dihydroquinoline-3-carboxylic Acid Hydrochloride

34. 7-[(4as,7as)-1,2,3,4,4a,5,7,7a-octahydropyrrolo[3,4-b]pyridin-6-yl]-1-cyclopropyl-6-fluoro-8-methoxy-4-oxoquinoline-3-carboxylic Acid;hydrochloride

35. Cas-186826-86-8

36. Moxifloxacin Hydrochloride [usan]

37. Moxivig

38. Vegamox

39. Actura

40. Moxifloxacin, Hcl

41. Unii-c53598599t

42. Ncgc00095130-01

43. 1-cyclopropyl-6-fluoro-8-methoxy-7-((4as,7as)-octahydro-6h-pyrrolo[3,4-b]pyridin-6-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic Acid Hydrochloride

44. 1-cyclopropyl-6-fluoro-8-methoxy-7-[(4as,7as)-octahydro-6h-pyrrolo[3,4-b]pyridin-6-yl]-4-oxo-1,4-dihydroquinoline-3-carboxylic Acid Hydrochloride

45. Mfcd00949117

46. Bay12-8039

47. Moxifloxacin Hydrochloride [usan:usp]

48. Avelox In Sodium Chloride 0.8% In Plastic Container

49. Cpd000469185

50. 1-cyclopropyl-6-fluoro-8-methoxy-7-((4as,7as)-octahydropyrrolo[3,4-b]pyridin-6-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic Acid Hydrochloride

51. Schembl37285

52. Mls001401368

53. Chembl1200735

54. Dtxsid4045921

55. Moxifloxacin Hcl [vandf]

56. Act02692

57. Amy25227

58. Bcp03623

59. Tox21_111439

60. Moxifloxacin Hydrochloride (jan/usp)

61. Akos015920132

62. Akos016015225

63. Tox21_111439_1

64. Ac-1275

65. Bcp9000963

66. Ccg-100924

67. Cs-1063

68. Ks-1181

69. Moxifloxacin Hydrochloride [mi]

70. Nc00174

71. Nsc 758875

72. Moxifloxacin Hydrochloride [jan]

73. Ncgc00271749-02

74. 3-quinolinecarboxylic Acid, 1-cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-((4as,7as)-octahydro-6h-pyrrolo(3,4-b)pyridin-6-yl)-4-oxo-, Monohydrochloride

75. Hy-66011

76. Moxifloxacin Hydrochloride [mart.]

77. Smr000469185

78. Bcp0726000173

79. Moxifloxacin Hydrochloride [usp-rs]

80. Moxifloxacin Hydrochloride [who-dd]

81. Moxifloxacin Hydrochloride, >=98% (hplc)

82. M2479

83. S1465

84. Sw197554-3

85. D00874

86. Moxifloxacin Hydrochloride [orange Book]

87. Moxifloxacin Hydrochloride [ep Monograph]

88. 826m868

89. Moxifloxacin Hydrochloride [usp Monograph]

90. Q27107395

91. 186826-86-8 151096-09-2(base)

92. Moxifloxacin Hydrochloride, Vetranal(tm), Analytical Standard

93. Moxifloxacin Hydrochloride, European Pharmacopoeia (ep) Reference Standard

94. Moxifloxacin For Peak Identification, European Pharmacopoeia (ep) Reference Standard

95. Moxifloxacin Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material

96. Moxifloxacin Hydrochloride, United States Pharmacopeia (usp) Reference Standard

97. 1-cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-[(4as,7as)-octahydro-1h-pyrrolo[3,4-b]pyridin-6-yl]-4-oxo-3-quinolinecarboxylic Acid Hydrochloride

98. 1-cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-[(4as,7as)-octahydro-6h-pyrrolo[3,4-b]pyridin-6-yl]-4-oxo-3-quinolinecarboxylic Acid Hydrochloride (1:1)

99. 1-cyclopropyl-6-fluoro-7-((4as,7as)-hexahydro-1h-pyrrolo[3,4-b]pyridin-6(2h)-yl)-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic Acid Hcl

100. 1-cyclopropyl-6-fluoro-7-((4as,7as)-hexahydro-1h-pyrrolo[3,4-b]pyridin-6(2h)-yl)-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylicacidhydrochloride

101. 7-[[(4as,8as)-2,3,4,4a,5,6,8,8a-octahydro-1h-1,7-naphthyridin-7-yl]methyl]-1-cyclopropyl-6-fluoro-8-methoxy-4-oxoquinoline-3-carboxylic Acid;hydrochloride

2.4 Create Date

2005-08-08

3 Chemical and Physical Properties

Molecular Formula	C₂₁H₂₅ClFN₃O₄
Molecular Weight	437.9 g/mol
Hydrogen Bond Donor Count	3
Hydrogen Bond Acceptor Count	8
Rotatable Bond Count	4
Exact Mass	437.1517621 g/mol
Monoisotopic Mass	437.1517621 g/mol
Topological Polar Surface Area	82.1 Å²
Heavy Atom Count	30
Formal Charge	0
Complexity	727
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 8
Drug Name	Avelox
Drug Label	DESCRIPTIONAVELOX (moxifloxacin hydrochloride) is a synthetic broad spectrum antibacterial agent and is available as AVELOX Tablets for oral administration and as AVELOX I.V. for intravenous administration. Moxifloxacin, a fluoroquinolone, is availab...
Active Ingredient	Moxifloxacin hydrochloride
Dosage Form	Tablet
Route	oral; Oral
Strength	eq 400mg base; 400mg
Market Status	Prescription
Company	Bayer Pharms; Bayer Hlthcare

2 of 8
Drug Name	Moxeza
PubMed Health	Moxifloxacin
Drug Classes	Antibiotic
Drug Label	MOXEZA is a sterile solution for topical ophthalmic use.Moxifloxacin hydrochloride is an 8-methoxy fluoroquinolone anti-infective, with a diazabicyclononyl ring at the C7 position. C21H24FN3O4HClMol Wt 437.9...
Active Ingredient	Moxifloxacin hydrochloride
Dosage Form	Solution/drops
Route	Ophthalmic
Strength	eq 0.5% base
Market Status	Prescription
Company	Alcon Pharms

3 of 8
Drug Name	Moxifloxacin hydrochloride
PubMed Health	Moxifloxacin
Drug Classes	Antibiotic
Drug Label	DESCRIPTIONAVELOX (moxifloxacin hydrochloride) is a synthetic broad spectrum antibacterial agent and is available as AVELOX Tablets for oral administration and as AVELOX I.V. for intravenous administration. Moxifloxacin, a fluoroquinolone, is availab...
Active Ingredient	Moxifloxacin hydrochloride
Dosage Form	Solution/drops; Tablet; Solution
Route	Ophthalmic; Oral; ophthalmic
Strength	0.5%; eq 0.5% base; eq 400mg base
Market Status	Tentative Approval; Prescription
Company	Apotex; Aurobindo Pharma; Teva Pharms Usa; Torrent Pharms; Lupin; Teva Pharms; Dr Reddys Labs

4 of 8
Drug Name	Vigamox
PubMed Health	Moxifloxacin
Drug Classes	Antibiotic
Drug Label	VIGAMOX (moxifloxacin HCl ophthalmic solution) 0.5% is a sterile ophthalmic solution. It is an 8-methoxy fluoroquinolone anti-infective for topical ophthalmic use.Chemical Name:1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-[(4aS,7aS)-octahydro-6H-...
Active Ingredient	Moxifloxacin hydrochloride
Dosage Form	Solution/drops
Route	Ophthalmic
Strength	eq 0.5% base
Market Status	Prescription
Company	Alcon Pharms

5 of 8
Drug Name	Avelox
Drug Label	DESCRIPTIONAVELOX (moxifloxacin hydrochloride) is a synthetic broad spectrum antibacterial agent and is available as AVELOX Tablets for oral administration and as AVELOX I.V. for intravenous administration. Moxifloxacin, a fluoroquinolone, is availab...
Active Ingredient	Moxifloxacin hydrochloride
Dosage Form	Tablet
Route	oral; Oral
Strength	eq 400mg base; 400mg
Market Status	Prescription
Company	Bayer Pharms; Bayer Hlthcare

6 of 8
Drug Name	Moxeza
PubMed Health	Moxifloxacin
Drug Classes	Antibiotic
Drug Label	MOXEZA is a sterile solution for topical ophthalmic use.Moxifloxacin hydrochloride is an 8-methoxy fluoroquinolone anti-infective, with a diazabicyclononyl ring at the C7 position. C21H24FN3O4HClMol Wt 437.9...
Active Ingredient	Moxifloxacin hydrochloride
Dosage Form	Solution/drops
Route	Ophthalmic
Strength	eq 0.5% base
Market Status	Prescription
Company	Alcon Pharms

7 of 8
Drug Name	Moxifloxacin hydrochloride
PubMed Health	Moxifloxacin
Drug Classes	Antibiotic
Drug Label	DESCRIPTIONAVELOX (moxifloxacin hydrochloride) is a synthetic broad spectrum antibacterial agent and is available as AVELOX Tablets for oral administration and as AVELOX I.V. for intravenous administration. Moxifloxacin, a fluoroquinolone, is availab...
Active Ingredient	Moxifloxacin hydrochloride
Dosage Form	Solution/drops; Tablet; Solution
Route	Ophthalmic; Oral; ophthalmic
Strength	0.5%; eq 0.5% base; eq 400mg base
Market Status	Tentative Approval; Prescription
Company	Apotex; Aurobindo Pharma; Teva Pharms Usa; Torrent Pharms; Lupin; Teva Pharms; Dr Reddys Labs

8 of 8
Drug Name	Vigamox
PubMed Health	Moxifloxacin
Drug Classes	Antibiotic
Drug Label	VIGAMOX (moxifloxacin HCl ophthalmic solution) 0.5% is a sterile ophthalmic solution. It is an 8-methoxy fluoroquinolone anti-infective for topical ophthalmic use.Chemical Name:1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-[(4aS,7aS)-octahydro-6H-...
Active Ingredient	Moxifloxacin hydrochloride
Dosage Form	Solution/drops
Route	Ophthalmic
Strength	eq 0.5% base
Market Status	Prescription
Company	Alcon Pharms

4.2 Drug Indication

Acute Exacerbation of Chronic Bronchitis, Community Acquired Pneumonia, Complicated Intra-Abdominal Infection, Complicated Skin and Skin Structure Infections, Pelvic Inflammatory Disease, Treatment of acute bacterial sinusitis

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Topoisomerase II Inhibitors

Compounds that inhibit the activity of DNA TOPOISOMERASE II. Included in this category are a variety of ANTINEOPLASTIC AGENTS which target the eukaryotic form of topoisomerase II and ANTIBACTERIAL AGENTS which target the prokaryotic form of topoisomerase II. (See all compounds classified as Topoisomerase II Inhibitors.)

Anti-Bacterial Agents

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

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Quinolones [CS]; Quinolone Antimicrobial [EPC]

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API Reference Price

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Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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DOSAGE - TABLET;ORAL - EQ 400MG BASE **Federa...DOSAGE - TABLET;ORAL - EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 21085

DOSAGE - SOLUTION;INTRAVENOUS - 400MG/250ML (...DOSAGE - SOLUTION;INTRAVENOUS - 400MG/250ML (1.6MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 21277

DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 0.5% ...DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 0.5% BASE

USFDA APPLICATION NUMBER - 21598

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TABLET;ORAL - EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

SOLUTION;INTRAVENOUS - 400MG/250ML (1.6MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

SOLUTION/DROPS;OPHTHALMIC - EQ 0.5% BASE

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TABLET;ORAL - EQ 400MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

SOLUTION;INTRAVENOUS - 400MG/250ML (1.6MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons