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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Harvard Business School
Chinese Patent Office
Daiichi Sankyo

Generated: March 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 070772

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NDA 070772 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 070772
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 070772
Medical Subject Heading (MeSH) Categories for 070772
Suppliers and Packaging for NDA: 070772
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METRONIDAZOLE metronidazole TABLET;ORAL 070772 ANDA Sun Pharmaceutical Industries, Inc. 57664-653 E 57664-653-10
METRONIDAZOLE metronidazole TABLET;ORAL 070772 ANDA Sun Pharmaceutical Industries, Inc. 57664-653 E 57664-653-88

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Jul 16, 1986TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Jul 16, 1986TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
US Army
Argus Health
Cantor Fitzgerald

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