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Last Updated: July 4, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 211786


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NDA 211786 describes METRONIDAZOLE, which is a drug marketed by Able, Alembic Pharms Ltd, Par Pharm, Acp Nimble, Fougera Pharms, Taro, Tolmar, Perrigo Uk Finco, Abbott, Abraxis Pharm, Intl Medication, Watson Labs, West-ward Pharms Int, Aurobindo Pharma Ltd, Cadila, Cadila Pharms Ltd, Chartwell Molecules, Flamingo Pharms, Fosun Pharma, Halsey, Heritage Pharms Inc, Innogenix, Ivax Sub Teva Pharms, LNK, Lupin Ltd, Mutual Pharm, Orit Labs Llc, Pliva, Strides Pharma, Superpharm, Teva Pharms Usa, Unichem Labs Ltd, Watson Labs Inc, Baxter Hlthcare Corp, Hospira, Inforlife, and Mylan Labs Ltd, and is included in fifty-eight NDAs. It is available from forty-seven 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 211786
Tradename:METRONIDAZOLE
Applicant:Perrigo Uk Finco
Ingredient:metronidazole
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 211786
Medical Subject Heading (MeSH) Categories for 211786
Suppliers and Packaging for NDA: 211786
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METRONIDAZOLE metronidazole GEL;VAGINAL 211786 ANDA Perrigo New York Inc 45802-139 45802-139-70 1 TUBE in 1 CARTON (45802-139-70) > 70 g in 1 TUBE
METRONIDAZOLE metronidazole GEL;VAGINAL 211786 ANDA A-S Medication Solutions 50090-4809 50090-4809-0 1 TUBE in 1 CARTON (50090-4809-0) > 70 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;VAGINALStrength0.75%
Approval Date:Jul 2, 2019TE:ABRLD:No

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