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Details for New Drug Application (NDA): 077018

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NDA 077018 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, 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-one NDAs. It is available from sixty-three 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: 077018

Fougera Pharms
Therapeutic Class:Antibacterials

Pharmacology for NDA: 077018


Suppliers and Packaging for NDA: 077018

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GEL;TOPICAL 077018 ANDA E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. 0168-0275 0168-0275-45 1 TUBE in 1 CARTON (0168-0275-45) > 45 g in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength0.75%
Approval Date:Jun 6, 2006TE:ABRLD:No

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