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Serving 500+ biopharmaceutical companies globally:

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Colorcon

Generated: July 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090222

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NDA 090222 describes METRONIDAZOLE, which is a drug marketed by Tolmar, Intl Medication, Able, West-ward Pharms Int, Fougera Pharms, Superpharm, Flamingo Pharms, Ivax Sub Teva Pharms, Mutual Pharm, Taro, Sandoz, Halsey, Par Pharm, Alembic Pharms Ltd, Teva Pharms Usa, LNK, Chartwell Molecules, Pliva, Watson Labs, Vivimed Labs, Watson Labs Inc, Appco Pharma Llc, G And W Labs, Taro Pharm, Unichem Labs Ltd, Zydus Pharms Usa Inc, Strides Pharma, Abraxis Pharm, Allied Pharma Inc, Aurobindo Pharma Ltd, G And W Labs Inc, Orit Labs Llc, Abbott, Mylan Labs Ltd, Claris, and Hospira, and is included in fifty-five NDAs. It is available from sixty-six 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 NDA: 090222

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 090222

Ingredient-typeNitroimidazoles

Suppliers and Packaging for NDA: 090222

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METRONIDAZOLE
metronidazole
TABLET, EXTENDED RELEASE;ORAL 090222 ANDA Alembic Pharmaceuticals Limited 46708-021 46708-021-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-021-30)
METRONIDAZOLE
metronidazole
TABLET, EXTENDED RELEASE;ORAL 090222 ANDA Alembic Pharmaceuticals Limited 46708-021 46708-021-31 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-021-31)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength750MG
Approval Date:May 5, 2010TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Colorcon
US Department of Justice
Dow
Novartis
QuintilesIMS
Citi
Express Scripts
Accenture
Farmers Insurance
Queensland Health

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