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Generated: June 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 018764

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NDA 018764 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, 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, Abbott, Mylan Labs Ltd, Claris, and Hospira, and is included in fifty-four 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: 018764

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

Pharmacology for NDA: 018764

Ingredient-typeNitroimidazoles

Suppliers and Packaging for NDA: 018764

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METRONIDAZOLE
metronidazole
TABLET;ORAL 018764 NDA Physicians Total Care, Inc. 54868-0108 54868-0108-1 21 TABLET in 1 BOTTLE, PLASTIC (54868-0108-1)
METRONIDAZOLE
metronidazole
TABLET;ORAL 018764 NDA Physicians Total Care, Inc. 54868-0108 54868-0108-2 10 TABLET in 1 BOTTLE, PLASTIC (54868-0108-2)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength250MG
Approval Date:Sep 17, 1982TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength500MG
Approval Date:Dec 20, 1982TE:RLD:No


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Serving 500+ biopharmaceutical companies globally:

Boehringer Ingelheim
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Fish and Richardson
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Chubb
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Queensland Health

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