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Last Updated: November 22, 2024

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, 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 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	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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