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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 203458

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NDA 203458 describes METRONIDAZOLE, which is a drug marketed by Able, Alembic, Chartwell Rx, Cosette, Fougera Pharms, Zydus Lifesciences, Encube, Taro, Glenmark Pharms Ltd, Padagis Israel, Solaris Pharma Corp, Abbott, Abraxis Pharm, Hikma, Intl Medication, Watson Labs, Alembic Pharms Ltd, Aurobindo Pharma Ltd, Cadila, Cadila Pharms Ltd, Chartwell Molecules, Flamingo Pharms, Fosun Pharma, Halsey, Heritage Pharms Inc, 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-eight 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 203458

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

Pharmacology for NDA: 203458

Medical Subject Heading (MeSH) Categories for 203458

Anti-Infective Agents
Antiprotozoal Agents
Radiation-Sensitizing Agents

Suppliers and Packaging for NDA: 203458

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METRONIDAZOLE	metronidazole	TABLET;ORAL	203458	ANDA	Unichem Pharmaceuticals (USA), Inc.	29300-226	29300-226-01	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-226-01)
METRONIDAZOLE	metronidazole	TABLET;ORAL	203458	ANDA	Unichem Pharmaceuticals (USA), Inc.	29300-226	29300-226-05	500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-226-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	250MG
Approval Date:	Jan 22, 2014	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Jan 22, 2014	TE:	AB	RLD:	No

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