Last Updated: May 21, 2026

Details for New Drug Application (NDA): 074569


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NDA 074569 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 074569
Tradename:CLONAZEPAM
Applicant:Teva
Ingredient:clonazepam
Patents:0
Pharmacology for NDA: 074569
Medical Subject Heading (MeSH) Categories for 074569
Anticonvulsants
GABA Modulators
Suppliers and Packaging for NDA: 074569
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLONAZEPAM clonazepam TABLET;ORAL 074569 ANDA Teva Pharmaceuticals USA, Inc. 0093-0832 0093-0832-01 100 TABLET in 1 BOTTLE (0093-0832-01)
CLONAZEPAM clonazepam TABLET;ORAL 074569 ANDA Teva Pharmaceuticals USA, Inc. 0093-0832 0093-0832-05 500 TABLET in 1 BOTTLE (0093-0832-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG
Approval Date:Sep 10, 1996TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Sep 10, 1996TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Sep 10, 1996TE:ABRLD:No

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Preferred Citation:

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