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Last Updated: August 9, 2020

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Details for New Drug Application (NDA): 208162

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NDA 208162 describes METRONIDAZOLE, which is a drug marketed by Able, Alembic Pharms Ltd, Par Pharm, Cosette, 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-six 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 208162
Tradename:METRONIDAZOLE
Applicant:Strides Pharma
Ingredient:metronidazole
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 208162
Medical Subject Heading (MeSH) Categories for 208162
Suppliers and Packaging for NDA: 208162
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METRONIDAZOLE metronidazole TABLET;ORAL 208162 ANDA Strides Pharma Science Limited 64380-779 64380-779-06 100 TABLET in 1 BOTTLE (64380-779-06)
METRONIDAZOLE metronidazole TABLET;ORAL 208162 ANDA Strides Pharma Science Limited 64380-779 64380-779-07 500 TABLET in 1 BOTTLE (64380-779-07)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:May 25, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:May 25, 2016TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
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Johnson and Johnson

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