Last Updated: May 4, 2026

Details for New Drug Application (NDA): 216750

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NDA 216750 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, Solaris Pharma Corp, Abbott, Abraxis Pharm, Hikma, Intl Medication, Watson Labs, Alembic Pharms Ltd, Cadila, Cadila Pharms Ltd, Chartwell Molecules, Flamingo Pharms, Fosun Pharma, Halsey, Innogenix, Ivax Sub Teva Pharms, LNK, Lupin Ltd, Mutual Pharm, Novitium Pharma, Pliva, Somerset Theraps Llc, Strides Pharma, Superpharm, Teva Pharms Usa, Unichem, Watson Labs Inc, Amneal, Baxter Hlthcare Corp, Gland, Hospira, Inforlife, and Rising, and is included in seventy-two NDAs. It is available from forty-eight 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 216750

Tradename:	METRONIDAZOLE
Applicant:	Sciegen Pharms
Ingredient:	metronidazole
Patents:	0

Pharmacology for NDA: 216750

Medical Subject Heading (MeSH) Categories for 216750

Anti-Infective Agents
Antiprotozoal Agents
Radiation-Sensitizing Agents

Suppliers and Packaging for NDA: 216750

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METRONIDAZOLE	metronidazole	GEL;VAGINAL	216750	ANDA	REMEDYREPACK INC.	70518-4572	70518-4572-0	1 TUBE, WITH APPLICATOR in 1 CARTON (70518-4572-0) / 70 g in 1 TUBE, WITH APPLICATOR
METRONIDAZOLE	metronidazole	GEL;VAGINAL	216750	ANDA	Saptalis Pharmaceuticals LLC	71656-067	71656-067-70	1 TUBE, WITH APPLICATOR in 1 CARTON (71656-067-70) / 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:	Dec 31, 2024	TE:	AB	RLD:	No

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