Metronidazole HCl

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ACTIVE PHARMA INGREDIENTS

35 API Suppliers, 16 USDMF, 11 CEP/COS, 1 JDMF, 1 EU WC, 14 KDMF, 11 NDC API, 17 Listed Suppliers, $ API Reference Price

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16 Drugs in Development

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DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 250MG, TABLET;ORAL - 500MG, INJECTABLE;INJECTION - 500MG/100ML, INJECTABLE;INJECTION - 500MG/100ML, GEL;TOPICAL - 0.75%, GEL;VAGINAL - 0.75%, GEL;VAGINAL - 1.3%, CREAM;TOPICAL - 0.75%, SUSPENSION;ORAL - 500MG/5ML, GEL;TOPICAL - 1%

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GLOBAL SALES INFORMATION

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PATENTS & EXCLUSIVITIES

9 US Patents, 5 Health Canada Patents

REF. STANDARDS & IMPURITIES

4 EDQM, 2 USP, 11 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

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USFDA APPLICATION NUMBER - 20531 / DOSAGE - CREAM;TOPICAL - 0.75%

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	Cosette Pharmaceuticals, Inc.	Harris Pharmaceutical, Inc.	Medimetriks Pharmaceuticals, Inc.	Owen Laboratories
Benzyl Alcohol(LKG8494WBH)
Glycerin(PDC6A3C0OX)
isopropyl palmitate(8CRQ2TH63M)
Lactic Acid(33X04XA5AT)
lactic acid, unspecified form(33X04XA5AT)
sodium hydroxide(55X04QC32I)
SORBITOL(506T60A25R)
WATER(059QF0KO0R)

Drug Product Composition: Metronidazole HCl