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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 205245

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NDA 205245 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 205245

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

Pharmacology for NDA: 205245

Medical Subject Heading (MeSH) Categories for 205245

Anti-Infective Agents
Antiprotozoal Agents
Radiation-Sensitizing Agents

Suppliers and Packaging for NDA: 205245

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METRONIDAZOLE	metronidazole	TABLET;ORAL	205245	ANDA	Major Pharmaceuticals	0904-7126	0904-7126-61	100 BLISTER PACK in 1 CARTON (0904-7126-61) / 1 TABLET in 1 BLISTER PACK
METRONIDAZOLE	metronidazole	TABLET;ORAL	205245	ANDA	Major Pharmaceuticals	0904-7156	0904-7156-61	100 BLISTER PACK in 1 CARTON (0904-7156-61) / 1 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	250MG
Approval Date:	Sep 23, 2015	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Sep 23, 2015	TE:	AB	RLD:	No

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