Last Updated: August 9, 2026

Details for New Drug Application (NDA): 206560

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NDA 206560 describes METRONIDAZOLE, which is a drug marketed by Able, Alembic, Chartwell Rx, Aurobindo Pharma Ltd, Cosette Pharms Nc, 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, 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-nine 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 206560

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

Pharmacology for NDA: 206560

Medical Subject Heading (MeSH) Categories for 206560

Anti-Infective Agents
Antiprotozoal Agents
Radiation-Sensitizing Agents

Suppliers and Packaging for NDA: 206560

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METRONIDAZOLE	metronidazole	TABLET;ORAL	206560	ANDA	ST. MARY'S MEDICAL PARK PHARMACY	60760-539	60760-539-14	14 TABLET in 1 BOTTLE, PLASTIC (60760-539-14)
METRONIDAZOLE	metronidazole	TABLET;ORAL	206560	ANDA	NuCare Pharmaceuticals,Inc.	68071-2409	68071-2409-1	4 TABLET in 1 BOTTLE (68071-2409-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	250MG
Approval Date:	Nov 16, 2016	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Nov 16, 2016	TE:	AB	RLD:	No

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