Last Updated: May 21, 2026

Details for New Drug Application (NDA): 077147


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NDA 077147 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 077147
Tradename:CLONAZEPAM
Applicant:Accord Hlthcare
Ingredient:clonazepam
Patents:0
Pharmacology for NDA: 077147
Medical Subject Heading (MeSH) Categories for 077147
Anticonvulsants
GABA Modulators
Suppliers and Packaging for NDA: 077147
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLONAZEPAM clonazepam TABLET;ORAL 077147 ANDA Accord Healthcare Inc. 16729-136 16729-136-00 100 TABLET in 1 BOTTLE, PLASTIC (16729-136-00)
CLONAZEPAM clonazepam TABLET;ORAL 077147 ANDA Accord Healthcare Inc. 16729-136 16729-136-16 500 TABLET in 1 BOTTLE, PLASTIC (16729-136-16)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG
Approval Date:May 2, 2005TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:May 2, 2005TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:May 2, 2005TE:ABRLD:No

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Preferred Citation:

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