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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 079067

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NDA 079067 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 079067

Tradename:	METRONIDAZOLE
Applicant:	Alembic Pharms Ltd
Ingredient:	metronidazole
Patents:	0

Pharmacology for NDA: 079067

Medical Subject Heading (MeSH) Categories for 079067

Anti-Infective Agents
Antiprotozoal Agents
Radiation-Sensitizing Agents

Suppliers and Packaging for NDA: 079067

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METRONIDAZOLE	metronidazole	TABLET;ORAL	079067	ANDA	Alembic Pharmaceuticals Limited	46708-428	46708-428-30	30 TABLET in 1 BOTTLE (46708-428-30)
METRONIDAZOLE	metronidazole	TABLET;ORAL	079067	ANDA	Alembic Pharmaceuticals Limited	46708-428	46708-428-31	100 TABLET in 1 BOTTLE (46708-428-31)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	250MG
Approval Date:	Mar 13, 2009	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Mar 13, 2009	TE:	AB	RLD:	No

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