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Details for New Drug Application (NDA): 077549

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NDA 077549 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: 077549

Tradename:
METRONIDAZOLE
Applicant:
G And W Labs
Ingredient:
metronidazole
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 077549

Ingredient-typeNitroimidazoles

Suppliers and Packaging for NDA: 077549

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METRONIDAZOLE
metronidazole
CREAM;TOPICAL 077549 ANDA G&W Laboratories, Inc. 0713-0633 0713-0633-37 45 g in 1 TUBE (0713-0633-37)
METRONIDAZOLE
metronidazole
CREAM;TOPICAL 077549 ANDA Medimetriks Pharmaceuticals, Inc. 43538-180 43538-180-45 45 g in 1 TUBE (43538-180-45)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength0.75%
Approval Date:Dec 19, 2007TE:ABRLD:No


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