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Last Updated: April 2, 2026

Details for New Drug Application (NDA): 077856


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NDA 077856 describes CLONAZEPAM, which is a drug marketed by Alembic, Barr, Ph Health, Sun Pharm Inds Inc, Accord Hlthcare, Actavis Elizabeth, Aurobindo Pharma Usa, Chartwell Rx, Pharmobedient, Prinston Inc, Rubicon Research, Sandoz, Teva, and Watson Labs, and is included in sixteen NDAs. It is available from twenty-nine 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. Thirty suppliers are listed for this compound. Additional details are available on the clonazepam profile page.
Summary for 077856
Tradename:CLONAZEPAM
Applicant:Prinston Inc
Ingredient:clonazepam
Patents:0
Pharmacology for NDA: 077856
Medical Subject Heading (MeSH) Categories for 077856
Anticonvulsants
GABA Modulators
Suppliers and Packaging for NDA: 077856
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLONAZEPAM clonazepam TABLET;ORAL 077856 ANDA Major Pharmaceuticals 0904-7227 0904-7227-61 100 BLISTER PACK in 1 CARTON (0904-7227-61) / 1 TABLET in 1 BLISTER PACK
CLONAZEPAM clonazepam TABLET;ORAL 077856 ANDA Major Pharmaceuticals 0904-7728 0904-7728-61 100 BLISTER PACK in 1 CARTON (0904-7728-61) / 1 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG
Approval Date:Jun 28, 2006TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Jun 28, 2006TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Jun 28, 2006TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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