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Generated: April 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020531

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NDA 020531 describes METROCREAM, which is a drug marketed by Galderma Labs Lp and is included in one NDA. It is available from three suppliers. Additional details are available on the METROCREAM profile page.

The generic ingredient in METROCREAM is metronidazole. There are eighteen drug master file entries for this compound. Eighty-five suppliers are listed for this compound. Additional details are available on the metronidazole profile page.

Summary for 020531

Tradename:	METROCREAM
Applicant:	Galderma Labs Lp
Ingredient:	metronidazole
Patents:	0
Therapeutic Class:	Antibacterials
Formulation / Manufacturing:	see details

Pharmacology for NDA: 020531

Ingredient-type	Nitroimidazoles

Medical Subject Heading (MeSH) Categories for 020531

Anti-Infective Agents
Antiprotozoal Agents
Radiation-Sensitizing Agents

Suppliers and Packaging for NDA: 020531

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METROCREAM	metronidazole	CREAM;TOPICAL	020531	NDA	Galderma Laboratories, L.P.	0299-3836	N	0299-3836-45
METROCREAM	metronidazole	CREAM;TOPICAL	020531	NDA AUTHORIZED GENERIC	Prasco Laboratories	66993-960	N	66993-960-45

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;TOPICAL			Strength	0.75%
Approval Date:	Sep 20, 1995	TE:	AB	RLD:	Yes

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Cantor Fitzgerald

Dow

Harvard Business School

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