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Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 070040

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NDA 070040 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 070040

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

Pharmacology for NDA: 070040

Ingredient-typeNitroimidazoles

Suppliers and Packaging for NDA: 070040

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METRONIDAZOLE metronidazole TABLET;ORAL 070040 ANDA Heritage Pharmaceuticals Inc. 23155-568 23155-568-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (23155-568-01)
METRONIDAZOLE metronidazole TABLET;ORAL 070040 ANDA Heritage Pharmaceuticals Inc. 23155-568 23155-568-10 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (23155-568-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Jan 29, 1985TE:ABRLD:No


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