Details for New Drug Application (NDA): 019737

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NDA 019737 describes METROGEL, which is a drug marketed by Galderma Labs Lp and Bausch and is included in three NDAs. It is available from three suppliers. Additional details are available on the METROGEL profile page.

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

Summary for 019737

Tradename:	METROGEL
Applicant:	Galderma Labs Lp
Ingredient:	metronidazole
Patents:	0

Medical Subject Heading (MeSH) Categories for 019737

Anti-Infective Agents
Antiprotozoal Agents
Radiation-Sensitizing Agents

Suppliers and Packaging for NDA: 019737

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METROGEL	metronidazole	GEL;TOPICAL	019737	NDA AUTHORIZED GENERIC	Prasco Laboratories	66993-962	66993-962-45	1 TUBE in 1 CARTON (66993-962-45) / 45 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	GEL;TOPICAL			Strength	0.75%
Approval Date:	Nov 22, 1988	TE:		RLD:	Yes

Expired US Patents for NDA 019737

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Galderma Labs Lp	METROGEL	metronidazole	GEL;TOPICAL	019737-001	Nov 22, 1988	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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