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Serving hundreds of leading biopharmaceutical companies globally:

Merck
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Johnson and Johnson
Express Scripts
Citi
Cipla
QuintilesIMS
US Army
Teva

Generated: April 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077264

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NDA 077264 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 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 077264
Tradename:METRONIDAZOLE
Applicant:Tolmar
Ingredient:metronidazole
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 077264
Ingredient-typeNitroimidazoles
Medical Subject Heading (MeSH) Categories for 077264
Suppliers and Packaging for NDA: 077264
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METRONIDAZOLE metronidazole GEL;VAGINAL 077264 ANDA Sandoz Inc. 0781-7077 N 0781-7077-87
METRONIDAZOLE metronidazole GEL;VAGINAL 077264 ANDA A-S Medication Solutions 50090-1012 N 50090-1012-0

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;VAGINALStrength0.75%
Approval Date:Oct 31, 2006TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Colorcon
US Army
Fish and Richardson
Daiichi Sankyo
Chubb
Boehringer Ingelheim
Deloitte
Healthtrust

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