Last Updated: June 24, 2026

Details for New Drug Application (NDA): 217128

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NDA 217128 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, 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 217128

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

Pharmacology for NDA: 217128

Medical Subject Heading (MeSH) Categories for 217128

Anti-Infective Agents
Antiprotozoal Agents
Radiation-Sensitizing Agents

Suppliers and Packaging for NDA: 217128

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METRONIDAZOLE	metronidazole	CREAM;TOPICAL	217128	ANDA	Preferred Pharmaceuticals Inc.	68788-8552	68788-8552-4	1 TUBE in 1 CARTON (68788-8552-4) / 45 g in 1 TUBE
METRONIDAZOLE	metronidazole	CREAM;TOPICAL	217128	ANDA	Zydus Lifesciences Limited	70771-1834	70771-1834-4	1 TUBE in 1 CARTON (70771-1834-4) / 45 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;TOPICAL			Strength	0.75%
Approval Date:	Apr 21, 2023	TE:	BX	RLD:	No

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