Last Updated: September 24, 2026

Details for New Drug Application (NDA): 204651

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NDA 204651 describes METRONIDAZOLE, which is a drug marketed by Able, Alembic, Chartwell Rx, Aurobindo Pharma Ltd, Cosette Pharms Nc, Fougera Pharms, Zydus Lifesciences, Encube, Taro, Glenmark Pharms Ltd, Padagis Israel, Sciegen Pharms, Solaris Pharma Corp, Abbott, Abraxis Pharm, Hikma, Intl Medication, Watson Labs, Alembic Pharms Ltd, Cadila, Cadila Pharms Ltd, Chartwell Molecules, Flamingo Pharms, Fosun Pharma, Halsey, Innogenix, Ivax Sub Teva Pharms, LNK, Lupin, Mutual Pharm, Novitium Pharma, Pliva, Somerset Theraps Llc, Strides Pharma, Superpharm, Teva Pharms Usa, Unichem, Watson Labs Inc, Amneal, Baxter Hlthcare Corp, Gland, Hospira, Inforlife, and Rising, and is included in seventy-two NDAs. It is available from forty-nine suppliers. Additional details are available on the METRONIDAZOLE profile page.

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

Summary for 204651

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

Pharmacology for NDA: 204651

Medical Subject Heading (MeSH) Categories for 204651

Anti-Infective Agents
Antiprotozoal Agents
Radiation-Sensitizing Agents

Suppliers and Packaging for NDA: 204651

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METRONIDAZOLE	metronidazole	GEL;TOPICAL	204651	ANDA	Sun Pharmaceutical Industries, Inc.	51672-4164	51672-4164-3	1 TUBE in 1 CARTON (51672-4164-3) / 60 g in 1 TUBE
METRONIDAZOLE	metronidazole	GEL;TOPICAL	204651	ANDA	Sun Pharmaceutical Industries, Inc.	51672-4164	51672-4164-6	1 TUBE in 1 CARTON (51672-4164-6) / 45 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL;TOPICAL			Strength	1%
Approval Date:	Mar 14, 2017	TE:	AB	RLD:	No

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