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Serving leading biopharmaceutical companies globally:

Express Scripts
Cantor Fitzgerald
AstraZeneca
Argus Health
Fish and Richardson
Chubb
McKesson
Daiichi Sankyo
Queensland Health
Cerilliant

Generated: January 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090903

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NDA 090903 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, Chartwell Molecules, Flamingo Pharms, Halsey, Innogenix, Ivax Sub Teva Pharms, LNK, Lupin Ltd, Mutual Pharm, Orit Labs Llc, Pliva, Sandoz, 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 090903
Tradename:METRONIDAZOLE
Applicant:Tolmar
Ingredient:metronidazole
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 090903
Ingredient-typeNitroimidazoles
Medical Subject Heading (MeSH) Categories for 090903
Suppliers and Packaging for NDA: 090903
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METRONIDAZOLE metronidazole GEL;TOPICAL 090903 ANDA Sandoz Inc. 0781-7080 0781-7080-35 1 TUBE in 1 CARTON (0781-7080-35) > 60 g in 1 TUBE
METRONIDAZOLE metronidazole GEL;TOPICAL 090903 ANDA Sandoz Inc. 0781-7080 0781-7080-55 1 BOTTLE, PUMP in 1 CARTON (0781-7080-55) > 55 g in 1 BOTTLE, PUMP

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength1%
Approval Date:Jul 22, 2011TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

US Department of Justice
Cantor Fitzgerald
Johnson and Johnson
Daiichi Sankyo
Chinese Patent Office
UBS
Moodys
Baxter
Mallinckrodt

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