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Last Updated: May 30, 2020

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Details for New Drug Application (NDA): 209808


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NDA 209808 describes CLOBAZAM, which is a drug marketed by Amneal Pharms Llc, Bionpharma Inc, Hetero Labs Ltd Iii, Hikma, Lupin Ltd, Mylan, Taro, Teva Pharms Usa, Upsher Smith Labs, Vistapharm, Accord Hlthcare, Alkem Labs Ltd, Amneal Pharms Co, Breckenridge, Lannett Co Inc, Micro Labs, Piramal Hlthcare Uk, and Zydus Pharms, and is included in twenty-four NDAs. It is available from eighteen suppliers. Additional details are available on the CLOBAZAM profile page.

The generic ingredient in CLOBAZAM is clobazam. There are ten drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the clobazam profile page.
Summary for 209808
Tradename:CLOBAZAM
Applicant:Piramal Hlthcare Uk
Ingredient:clobazam
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 209808
Suppliers and Packaging for NDA: 209808
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLOBAZAM clobazam TABLET;ORAL 209808 ANDA Sandoz Inc. 0781-8013 0781-8013-01 100 TABLET in 1 BOTTLE, PLASTIC (0781-8013-01)
CLOBAZAM clobazam TABLET;ORAL 209808 ANDA Sandoz Inc. 0781-8014 0781-8014-01 100 TABLET in 1 BOTTLE, PLASTIC (0781-8014-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Oct 22, 2018TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Oct 22, 2018TE:ABRLD:No

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