Last Updated: June 17, 2026

Details for New Drug Application (NDA): 021789

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NDA 021789 describes METROGEL, which is a drug marketed by Galderma Labs Lp and Bausch and is included in three NDAs. It is available from two 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. Sixty-seven suppliers are listed for this compound. Additional details are available on the metronidazole profile page.

Summary for 021789

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

Medical Subject Heading (MeSH) Categories for 021789

Anti-Infective Agents
Antiprotozoal Agents
Radiation-Sensitizing Agents

Suppliers and Packaging for NDA: 021789

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METROGEL	metronidazole	GEL;TOPICAL	021789	NDA AUTHORIZED GENERIC	Prasco Laboratories	66993-936	66993-936-61	60 g in 1 TUBE (66993-936-61)
METROGEL	metronidazole	GEL;TOPICAL	021789	NDA AUTHORIZED GENERIC	Mayne Pharma Inc.	68308-663	68308-663-55	1 BOTTLE, PUMP in 1 CARTON (68308-663-55) / 55 g in 1 BOTTLE, PUMP

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL;TOPICAL			Strength	1%
Approval Date:	Jun 30, 2005	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021789

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Galderma Labs Lp	METROGEL	metronidazole	GEL;TOPICAL	021789-001	Jun 30, 2005	⤷ Start Trial	⤷ Start Trial
Galderma Labs Lp	METROGEL	metronidazole	GEL;TOPICAL	021789-001	Jun 30, 2005	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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