Last Updated: May 3, 2026

Details for New Drug Application (NDA): 211033


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NDA 211033 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 211033
Tradename:CLONAZEPAM
Applicant:Alembic
Ingredient:clonazepam
Patents:0
Pharmacology for NDA: 211033
Medical Subject Heading (MeSH) Categories for 211033
Anticonvulsants
GABA Modulators
Suppliers and Packaging for NDA: 211033
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLONAZEPAM clonazepam TABLET, ORALLY DISINTEGRATING;ORAL 211033 ANDA Alembic Pharmaceuticals Limited 46708-364 46708-364-06 60 BLISTER PACK in 1 CARTON (46708-364-06) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
CLONAZEPAM clonazepam TABLET, ORALLY DISINTEGRATING;ORAL 211033 ANDA Alembic Pharmaceuticals Limited 46708-365 46708-365-06 60 BLISTER PACK in 1 CARTON (46708-365-06) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength0.125MG
Approval Date:Jun 28, 2019TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength0.25MG
Approval Date:Jun 28, 2019TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength0.5MG
Approval Date:Jun 28, 2019TE:ABRLD:No

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Preferred Citation:

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