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Generated: December 13, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077197

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NDA 077197 describes METRONIDAZOLE, which is a drug marketed by Able, Alembic Pharms Ltd, Par Pharm, Fougera Pharms, G And W Labs, G And W Labs Inc, Taro, Taro Pharm, Tolmar, Abbott, Abraxis Pharm, Intl Medication, Watson Labs, West-ward Pharms Int, Appco Pharma Llc, Aurobindo Pharma Ltd, Chartwell Molecules, Flamingo Pharms, Halsey, Innogenix, Ivax Sub Teva Pharms, LNK, Lupin Ltd, Mutual Pharm, Orit Labs Llc, Pliva, Sandoz, Strides Pharma, Superpharm, Teva Pharms Usa, Unichem Labs Ltd, Vivimed Global, Watson Labs Inc, Zydus Pharms Usa Inc, Baxter Hlthcare Corp, Hospira, and Mylan Labs Ltd, and is included in fifty-six NDAs. It is available from sixty-nine 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 077197

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

Pharmacology for NDA: 077197

Ingredient-typeNitroimidazoles

Suppliers and Packaging for NDA: 077197

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METRONIDAZOLE metronidazole LOTION;TOPICAL 077197 ANDA E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. 0168-0383 0168-0383-60 59 mL in 1 BOTTLE, PLASTIC (0168-0383-60)
METRONIDAZOLE metronidazole LOTION;TOPICAL 077197 ANDA Physicians Total Care, Inc. 54868-5882 54868-5882-0 59 mL in 1 BOTTLE, PLASTIC (54868-5882-0)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:LOTION;TOPICALStrength0.75%
Approval Date:May 24, 2006TE:ABRLD:No


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