Last Updated: May 11, 2026

Details for New Drug Application (NDA): 216795

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NDA 216795 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, 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 Ltd, 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-eight 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 216795

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

Pharmacology for NDA: 216795

Medical Subject Heading (MeSH) Categories for 216795

Anti-Infective Agents
Antiprotozoal Agents
Radiation-Sensitizing Agents

Suppliers and Packaging for NDA: 216795

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METRONIDAZOLE	metronidazole	GEL;VAGINAL	216795	ANDA	Encube Ethicals, Inc.	21922-046	21922-046-41	1 APPLICATOR in 1 CARTON (21922-046-41) / 5 g in 1 APPLICATOR

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	GEL;VAGINAL			Strength	1.3%
Approval Date:	Mar 18, 2024	TE:		RLD:	No

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