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Last Updated: December 12, 2024

Details for New Drug Application (NDA): 203974

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NDA 203974 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 203974

Tradename:	METRONIDAZOLE
Applicant:	Aurobindo Pharma Ltd
Ingredient:	metronidazole
Patents:	0

Pharmacology for NDA: 203974

Medical Subject Heading (MeSH) Categories for 203974

Anti-Infective Agents
Antiprotozoal Agents
Radiation-Sensitizing Agents

Suppliers and Packaging for NDA: 203974

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METRONIDAZOLE	metronidazole	TABLET;ORAL	203974	ANDA	Rising Pharma Holdings, Inc.	16571-664	16571-664-01	100 TABLET in 1 BOTTLE (16571-664-01)
METRONIDAZOLE	metronidazole	TABLET;ORAL	203974	ANDA	Rising Pharma Holdings, Inc.	16571-664	16571-664-50	500 TABLET in 1 BOTTLE (16571-664-50)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	250MG
Approval Date:	May 29, 2015	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	May 29, 2015	TE:	AB	RLD:	No

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