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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Daiichi Sankyo
Cantor Fitzgerald
Chinese Patent Office
Moodys
Mallinckrodt
Cerilliant
Novartis
Johnson and Johnson
Medtronic

Generated: February 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077197

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NDA 077197 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 seventy-one 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 077197
Tradename:METRONIDAZOLE
Applicant:Fougera Pharms
Ingredient:metronidazole
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 077197
Ingredient-typeNitroimidazoles
Medical Subject Heading (MeSH) Categories for 077197
Suppliers and Packaging for NDA: 077197
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METRONIDAZOLE metronidazole LOTION;TOPICAL 077197 ANDA E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. 0168-0383 N 0168-0383-60
METRONIDAZOLE metronidazole LOTION;TOPICAL 077197 ANDA Physicians Total Care, Inc. 54868-5882 E 54868-5882-0

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:LOTION;TOPICALStrength0.75%
Approval Date:May 24, 2006TE:ABRLD:No

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Harvard Business School
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US Department of Justice
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