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Details for New Drug Application (NDA): 076408

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NDA 076408 describes METRONIDAZOLE, which is a drug marketed by Tolmar, Intl Medication, Able, Eurohlth Intl Sarl, Fougera Pharms, Superpharm, Flamingo Pharms, Ivax Sub Teva Pharms, Mutual Pharm, Taro, Sandoz, Halsey, Par Pharm, Alembic Ltd, Teva Pharms Usa, LNK, Pliva, Watson Labs, Vivimed Labs, Watson Labs Inc, Appco Pharma Llc, G And W Labs, Unichem Labs Ltd, Zydus Pharms Usa Inc, Strides Pharma, Alembic Pharms Ltd, Abraxis Pharm, Nostrum Labs Inc, Aurobindo Pharma Ltd, G And W Labs Inc, Abbott, Claris, and Hospira, and is included in fifty-two NDAs. It is available from sixty-four 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: 076408

Tradename:
METRONIDAZOLE
Applicant:
Fougera Pharms
Ingredient:
metronidazole
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 076408

Ingredient-typeNitroimidazoles

Suppliers and Packaging for NDA: 076408

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METRONIDAZOLE
metronidazole
CREAM;TOPICAL 076408 ANDA E.FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. 0168-0323 0168-0323-46 45 g in 1 TUBE (0168-0323-46)
METRONIDAZOLE
metronidazole
CREAM;TOPICAL 076408 ANDA Physicians Total Care, Inc. 54868-5655 54868-5655-0 1 TUBE in 1 CARTON (54868-5655-0) > 45 g in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength0.75%
Approval Date:May 28, 2004TE:ABRLD:No


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