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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 077819

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NDA 077819 describes METRONIDAZOLE, which is a drug marketed by Able, Alembic, Chartwell Rx, Aurobindo Pharma Ltd, Cosette, Fougera Pharms, Zydus Lifesciences, Encube, Taro, Glenmark Pharms Ltd, Padagis Israel, Sciegen Pharms Inc, Solaris Pharma Corp, Abbott, Abraxis Pharm, Hikma, Intl Medication, Watson Labs, Alembic Pharms Ltd, Appco, Cadila, Cadila Pharms Ltd, Chartwell Molecules, Flamingo Pharms, Fosun Pharma, Halsey, Innogenix, Ivax Sub Teva Pharms, LNK, Lupin Ltd, Mutual Pharm, Novitium Pharma, Pliva, Strides Pharma, Superpharm, Teva Pharms Usa, Unichem, Watson Labs Inc, Amneal, Baxter Hlthcare Corp, Gland, Hospira, Inforlife, and Rising, and is included in seventy-one NDAs. It is available from fifty-one suppliers. Additional details are available on the METRONIDAZOLE profile page.

The generic ingredient in METRONIDAZOLE is metronidazole hydrochloride. There are eighteen drug master file entries for this compound. Additional details are available on the metronidazole hydrochloride profile page.

Summary for 077819

Tradename:	METRONIDAZOLE
Applicant:	Taro
Ingredient:	metronidazole
Patents:	0

Pharmacology for NDA: 077819

Medical Subject Heading (MeSH) Categories for 077819

Anti-Infective Agents
Antiprotozoal Agents
Radiation-Sensitizing Agents

Suppliers and Packaging for NDA: 077819

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METRONIDAZOLE	metronidazole	GEL;TOPICAL	077819	ANDA	Taro Pharmaceuticals U.S.A., Inc.	51672-4116	51672-4116-2	1 TUBE in 1 CARTON (51672-4116-2) / 30 g in 1 TUBE
METRONIDAZOLE	metronidazole	GEL;TOPICAL	077819	ANDA	Taro Pharmaceuticals U.S.A., Inc.	51672-4116	51672-4116-5	5 g in 1 TUBE (51672-4116-5)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL;TOPICAL			Strength	0.75%
Approval Date:	Jul 18, 2006	TE:	AB	RLD:	No

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