Last Updated: May 10, 2026

Details for New Drug Application (NDA): 220095

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NDA 220095 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 220095

Tradename:	METRONIDAZOLE
Applicant:	Zydus Lifesciences
Ingredient:	metronidazole
Patents:	0

Pharmacology for NDA: 220095

Medical Subject Heading (MeSH) Categories for 220095

Anti-Infective Agents
Antiprotozoal Agents
Radiation-Sensitizing Agents

Suppliers and Packaging for NDA: 220095

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METRONIDAZOLE	metronidazole	GEL;TOPICAL	220095	ANDA	Zydus Lifesciences Limited	70771-1978	70771-1978-4	1 TUBE in 1 CARTON (70771-1978-4) / 45 g in 1 TUBE
METRONIDAZOLE	metronidazole	GEL;TOPICAL	220095	ANDA	Viona Pharmaceuticals Inc	72578-209	72578-209-04	1 TUBE in 1 CARTON (72578-209-04) / 45 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL;TOPICAL			Strength	0.75%
Approval Date:	Feb 13, 2026	TE:	AB	RLD:	No

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