Metronidazole

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ACTIVE PHARMA INGREDIENTS

59 API Suppliers, 16 USDMF, 13 CEP/COS, 1 JDMF, 3 EU WC, 15 KDMF, 11 NDC API, 19 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

87 Drugs in Development

87 Drugs in Development

FINISHED DOSAGE FORMULATIONS

465 FDF Dossiers, 119 FDA Orange Book, 143 Europe, 16 Canada, 14 Australia, 50 South Africa, 123 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - 500MG/100ML, INJECTABLE;INJECTION - 500MG/100ML, GEL;TOPICAL - 0.75% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, GEL;VAGINAL - 0.75%, GEL;VAGINAL - 1.3%, CREAM;TOPICAL - 0.75%, SUSPENSION;ORAL - 500MG/5ML, GEL;TOPICAL - 1%

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 1 Rochem International Inc, 6 SPI Pharma, 13 DKSH, 5 Boai NKY Pharmaceuticals Ltd, 6 Gangwal Healthcare, 7 Nanjing Well Pharmaceutical, 7 Kirsch Pharma, 4 ACG Worldwide, 12 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 2 Ashland, 29 BASF, 2 CD Formulation, 1 Clariant, 17 Corel Pharma Chem, 6 DFE Pharma, 1 Esteem Industries, 3 Finar, 11 Gangwal Chemicals, 4 Ideal Cures, 3 Ingredion Pharma Solutions, 24 Kerry, 2 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 8 Lubrizol Life Science Health, 15 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 3 Novo Excipients, 4 Pharmatrans-Sanaq, 5 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 32 Roquette, 14 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 3 Silverline Chemicals, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 3 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

63 Fillers, Diluents & Binders, 49 Thickeners and Stabilizers, 45 Coating Systems & Additives, 40 Solubilizers, 37 Direct Compression, 36 Topical, 32 Granulation, 31 Disintegrants & Superdisintegrants, 30 Controlled & Modified Release, 26 Parenteral, 22 Film Formers & Plasticizers, 19 Lubricants & Glidants, 18 Taste Masking, 13 Chewable & Orodispersible Aids, 12 Co-Processed Excipients, 9 Empty Capsules, 9 Emulsifying Agents, 7 Rheology Modifiers, 6 API Stability Enhancers, 5 Coloring Agents, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 1 Soft Gelatin

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33 US Medicaid Prescriptions, 65 Regulatory FDF Prices

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79 APIs, 40 FDF Dossiers

PATENTS & EXCLUSIVITIES

11 US Patents, 3 Health Canada Patents

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4 EDQM, 18 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

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USFDA APPLICATION NUMBER - 19737 / DOSAGE - GEL;TOPICAL - 0.75% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
METRONIDAZOLE(UNII: 140QMO216E) (Metronidazole - UNII:140QMO216E)	METRONIDAZOLE	7.5mg in 1

Inactive Ingredients

Ingredient Name	Owen Laboratories
CARBOMER 940(4Q93RCW27E)
EDETATE DISODIUM(7FLD91C86K)
METHYLPARABEN(A2I8C7HI9T)
PROPYLENE GLYCOL(6DC9Q167V3)
PROPYLPARABEN(Z8IX2SC1OH)
SODIUM HYDROXIDE(55X04QC32I)
WATER(059QF0KO0R)

Setid 35bbbdc7 A8c5 4207 B671 2b1d2920df93 Applno 19737 Form Gel Topical Dosage 0 75 - Drug Product Composition: Metronidazole

Metronidazole

Metronidazole

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CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

59 API Suppliers

16 USDMF

13 CEP/COS

1 JDMF

3 EU WC

15 KDMF

11 NDC API

19 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

87 Drugs in Development

FINISHED DOSAGE FORMULATIONS

465 FDF Dossiers

119 FDA Orange Book

143 Europe

16 Canada

14 Australia

50 South Africa

123 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 250MG **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**

INJECTABLE;INJECTION - 500MG/100ML

INJECTABLE;INJECTION - 500MG/100ML

GEL;TOPICAL - 0.75% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

GEL;VAGINAL - 0.75%

GEL;VAGINAL - 1.3%

CREAM;TOPICAL - 0.75%

SUSPENSION;ORAL - 500MG/5ML

GEL;TOPICAL - 1%

RELATED EXCIPIENT COMPANIES

2 EUROAPI

1 Rochem International Inc

6 SPI Pharma

13 DKSH

5 Boai NKY Pharmaceuticals Ltd

6 Gangwal Healthcare

7 Nanjing Well Pharmaceutical

7 Kirsch Pharma

4 ACG Worldwide

12 Actylis

1 Aeon Procare

1 Alcedo Pharmachem

9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

2 Ashland

29 BASF

2 CD Formulation

1 Clariant

17 Corel Pharma Chem

6 DFE Pharma

1 Esteem Industries

3 Finar

11 Gangwal Chemicals

4 Ideal Cures

3 Ingredion Pharma Solutions

24 Kerry

2 Keval Exports

3 Kima Chemical

6 Lonza Capsugel

8 Lubrizol Life Science Health

15 Microlex e.U

1 Nanjing Bold Chemical

2 Nitika Pharmaceutical Specialities

2 Nomisma Healthcare

3 Novo Excipients

4 Pharmatrans-Sanaq

5 Pluviaendo

3 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

2 Qualicaps

32 Roquette

14 Seppic

TABLET;ORAL - 250MG 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

GEL;TOPICAL - 0.75% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons