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Generated: August 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 079067

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NDA 079067 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: 079067

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 079067

Ingredient-typeNitroimidazoles

Suppliers and Packaging for NDA: 079067

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METRONIDAZOLE
metronidazole
TABLET;ORAL 079067 ANDA Heritage Pharmaceuticals Inc. 23155-064 23155-064-01 100 TABLET in 1 BOTTLE (23155-064-01)
METRONIDAZOLE
metronidazole
TABLET;ORAL 079067 ANDA Heritage Pharmaceuticals Inc. 23155-064 23155-064-03 30 TABLET in 1 BOTTLE (23155-064-03)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Mar 13, 2009TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Mar 13, 2009TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

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Chinese Patent Office
Fish and Richardson
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