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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 070033

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NDA 070033 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-three 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 070033

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

Pharmacology for NDA: 070033

Medical Subject Heading (MeSH) Categories for 070033

Anti-Infective Agents
Antiprotozoal Agents
Radiation-Sensitizing Agents

Suppliers and Packaging for NDA: 070033

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METRONIDAZOLE	metronidazole	TABLET;ORAL	070033	ANDA	Teva Pharmaceuticals USA, Inc.	50111-334	50111-334-01	100 TABLET in 1 BOTTLE (50111-334-01)
METRONIDAZOLE	metronidazole	TABLET;ORAL	070033	ANDA	Teva Pharmaceuticals USA, Inc.	50111-334	50111-334-02	500 TABLET in 1 BOTTLE (50111-334-02)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Dec 6, 1984	TE:	AB	RLD:	No

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