BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Cantor Fitzgerald
Fuji
QuintilesIMS
Baxter
UBS
Teva
Johnson and Johnson
Julphar
Deloitte

Generated: January 16, 2018

DrugPatentWatch Database Preview

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, 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 seventy 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
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 208162
Ingredient-typeNitroimidazoles
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 Shasun Limited 64380-779 64380-779-06 100 TABLET in 1 BOTTLE (64380-779-06)
METRONIDAZOLE metronidazole TABLET;ORAL 208162 ANDA Strides Shasun Limited 64380-779 64380-779-38 250 TABLET in 1 BOTTLE (64380-779-38)

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:

Mallinckrodt
Healthtrust
Chinese Patent Office
Julphar
Cantor Fitzgerald
Daiichi Sankyo
Medtronic
Fish and Richardson
Farmers Insurance

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