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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
QuintilesIMS
Johnson and Johnson
Chinese Patent Office
US Department of Justice
Citi
Cantor Fitzgerald
US Army
Harvard Business School

Generated: April 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077549

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NDA 077549 describes METRONIDAZOLE, which is a drug marketed by Able, Alembic Pharms Ltd, Par Pharm, Fougera Pharms, G And W Labs, G And W Labs Inc, Taro, Taro Pharm, Tolmar, Abbott, Abraxis Pharm, Intl Medication, Watson Labs, West-ward Pharms Int, Appco Pharma Llc, Aurobindo Pharma Ltd, Cadila Pharms Ltd, Chartwell Molecules, Flamingo Pharms, Fosun Pharma, Halsey, Innogenix, Ivax Sub Teva Pharms, LNK, Lupin Ltd, Mutual Pharm, Orit Labs Llc, Pliva, Strides Pharma, Superpharm, Teva Pharms Usa, Unichem Labs Ltd, Vivimed Global, Watson Labs Inc, Zydus Pharms Usa Inc, Baxter Hlthcare Corp, Hospira, and Mylan Labs Ltd, and is included in fifty-six NDAs. It is available from sixty-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 077549
Tradename:METRONIDAZOLE
Applicant:G And W Labs
Ingredient:metronidazole
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 077549
Ingredient-typeNitroimidazoles
Medical Subject Heading (MeSH) Categories for 077549
Suppliers and Packaging for NDA: 077549
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METRONIDAZOLE metronidazole CREAM;TOPICAL 077549 ANDA G&W Laboratories, Inc. 0713-0633 N 0713-0633-37
METRONIDAZOLE metronidazole CREAM;TOPICAL 077549 ANDA Medimetriks Pharmaceuticals, Inc. 43538-180 N 43538-180-45

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength0.75%
Approval Date:Dec 19, 2007TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Baxter
Harvard Business School
McKinsey
US Army
AstraZeneca
Express Scripts
Deloitte
Accenture

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