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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 079065

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NDA 079065 describes METRONIDAZOLE, which is a drug marketed by Able, Alembic, Chartwell Rx, Cosette, Fougera Pharms, Zydus Lifesciences, Aurobindo Pharma Ltd, Encube, Taro, Glenmark Pharms Ltd, Padagis Israel, Solaris Pharma Corp, Abbott, Abraxis Pharm, Hikma, Intl Medication, Watson Labs, Alembic Pharms Ltd, Appco, Cadila, Cadila Pharms Ltd, Chartwell Molecules, Esjay Pharma, Flamingo Pharms, Fosun Pharma, Halsey, Innogenix, Ivax Sub Teva Pharms, LNK, Lupin Ltd, Mutual Pharm, Pliva, Strides Pharma, Superpharm, Teva Pharms Usa, Unichem, Watson Labs Inc, Amneal, Baxter Hlthcare Corp, Gland Pharma Ltd, Hospira, Inforlife, and Rising, and is included in sixty-nine NDAs. It is available from fifty-four 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 079065

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

Pharmacology for NDA: 079065

Medical Subject Heading (MeSH) Categories for 079065

Anti-Infective Agents
Antiprotozoal Agents
Radiation-Sensitizing Agents

Suppliers and Packaging for NDA: 079065

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METRONIDAZOLE	metronidazole	CAPSULE;ORAL	079065	ANDA	Alembic Pharmaceuticals Limited	46708-435	46708-435-30	30 CAPSULE in 1 BOTTLE (46708-435-30)
METRONIDAZOLE	metronidazole	CAPSULE;ORAL	079065	ANDA	Alembic Pharmaceuticals Limited	46708-435	46708-435-31	100 CAPSULE in 1 BOTTLE (46708-435-31)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	375MG
Approval Date:	Jun 23, 2009	TE:	AB	RLD:	No

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