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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 213648

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NDA 213648 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 213648

Tradename:	METRONIDAZOLE
Applicant:	Solaris Pharma Corp
Ingredient:	metronidazole
Patents:	0

Pharmacology for NDA: 213648

Medical Subject Heading (MeSH) Categories for 213648

Anti-Infective Agents
Antiprotozoal Agents
Radiation-Sensitizing Agents

Suppliers and Packaging for NDA: 213648

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METRONIDAZOLE	metronidazole	GEL;VAGINAL	213648	ANDA	REMEDYREPACK INC.	70518-4495	70518-4495-0	1 TUBE, WITH APPLICATOR in 1 CARTON (70518-4495-0) / 70 g in 1 TUBE, WITH APPLICATOR
METRONIDAZOLE	metronidazole	GEL;VAGINAL	213648	ANDA	Solaris Pharma Corporation	73473-303	73473-303-70	1 TUBE, WITH APPLICATOR in 1 CARTON (73473-303-70) / 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:	Oct 14, 2021	TE:	AB	RLD:	No

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