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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 207309

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NDA 207309 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 207309

Tradename:	METRONIDAZOLE
Applicant:	Flamingo Pharms
Ingredient:	metronidazole
Patents:	0

Medical Subject Heading (MeSH) Categories for 207309

Anti-Infective Agents
Antiprotozoal Agents
Radiation-Sensitizing Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	250MG
Approval Date:	May 16, 2016	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	May 16, 2016	TE:		RLD:	No

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