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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
Healthtrust
Deloitte
Boehringer Ingelheim
QuintilesIMS
US Army
Merck
Federal Trade Commission
McKinsey

Generated: June 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 070044

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NDA 070044 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-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 070044
Tradename:METRONIDAZOLE
Applicant:Watson Labs Inc
Ingredient:metronidazole
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 070044
Ingredient-typeNitroimidazoles
Medical Subject Heading (MeSH) Categories for 070044
Suppliers and Packaging for NDA: 070044
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METRONIDAZOLE metronidazole TABLET;ORAL 070044 ANDA Actavis Pharma, Inc. 0591-5215 N 0591-5215-05
METRONIDAZOLE metronidazole TABLET;ORAL 070044 ANDA Actavis Pharma, Inc. 0591-5215 N 0591-5215-50

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Feb 8, 1985TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Argus Health
Johnson and Johnson
Fish and Richardson
Cerilliant
Cantor Fitzgerald
Merck
Farmers Insurance
Teva

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