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Last Updated: December 12, 2024

Details for New Drug Application (NDA): 215794

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NDA 215794 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 215794

Tradename:	METRONIDAZOLE
Applicant:	Glenmark Pharms Ltd
Ingredient:	metronidazole
Patents:	0

Pharmacology for NDA: 215794

Medical Subject Heading (MeSH) Categories for 215794

Anti-Infective Agents
Antiprotozoal Agents
Radiation-Sensitizing Agents

Suppliers and Packaging for NDA: 215794

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METRONIDAZOLE	metronidazole	GEL;VAGINAL	215794	ANDA	Northstar Rx LLC	16714-557	16714-557-01	1 TUBE, WITH APPLICATOR in 1 CARTON (16714-557-01) / 70 g in 1 TUBE, WITH APPLICATOR
METRONIDAZOLE	metronidazole	GEL;VAGINAL	215794	ANDA	A-S Medication Solutions	50090-7160	50090-7160-0	1 TUBE, WITH APPLICATOR in 1 CARTON (50090-7160-0) / 70 g in 1 TUBE, WITH APPLICATOR

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL;VAGINAL			Strength	0.75%
Approval Date:	Jan 27, 2022	TE:	AB	RLD:	No

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