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US Department of Justice
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Generated: February 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078654

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NDA 078654 describes CLONAZEPAM, which is a drug marketed by Barr, Par Pharm, Sun Pharm Inds Inc, Accord Hlthcare, Actavis Elizabeth, Apotex Inc, Mylan, Mylan Pharms Inc, Prinston Inc, Sandoz, Teva, and Watson Labs, and is included in fifteen NDAs. It is available from forty-seven suppliers. Additional details are available on the CLONAZEPAM profile page.

The generic ingredient in CLONAZEPAM is clonazepam. There are ten drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the clonazepam profile page.
Summary for 078654
Applicant:Sun Pharm Inds Inc
Formulation / Manufacturing:see details
Pharmacology for NDA: 078654
Medical Subject Heading (MeSH) Categories for 078654
Suppliers and Packaging for NDA: 078654
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLONAZEPAM clonazepam TABLET, ORALLY DISINTEGRATING;ORAL 078654 ANDA Sun Pharmaceutical Industries, Inc. 57664-783 N 57664-783-88
CLONAZEPAM clonazepam TABLET, ORALLY DISINTEGRATING;ORAL 078654 ANDA Sun Pharmaceutical Industries, Inc. 57664-783 N 57664-783-86

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength0.125MG
Approval Date:Aug 27, 2014TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength0.25MG
Approval Date:Aug 27, 2014TE:ABRLD:No

Profile for product number 003

Approval Date:Aug 27, 2014TE:ABRLD:No

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