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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 077194


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NDA 077194 describes CLONAZEPAM, which is a drug marketed by Alembic, Barr, Par Pharm, Sun Pharm Inds Inc, Accord Hlthcare, Actavis Elizabeth, Aurobindo Pharma Usa, Chartwell Rx, Mylan Pharms Inc, Prinston Inc, Rubicon, Sandoz, Teva, and Watson Labs, and is included in sixteen NDAs. It is available from thirty-one 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-two suppliers are listed for this compound. Additional details are available on the clonazepam profile page.
Summary for 077194
Tradename:CLONAZEPAM
Applicant:Barr
Ingredient:clonazepam
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 077194
Medical Subject Heading (MeSH) Categories for 077194
Suppliers and Packaging for NDA: 077194
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLONAZEPAM clonazepam TABLET, ORALLY DISINTEGRATING;ORAL 077194 ANDA Teva Pharmaceuticals USA, Inc. 0093-9290 0093-9290-67 60 BLISTER PACK in 1 CARTON (0093-9290-67) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
CLONAZEPAM clonazepam TABLET, ORALLY DISINTEGRATING;ORAL 077194 ANDA Teva Pharmaceuticals USA, Inc. 0093-9291 0093-9291-67 60 BLISTER PACK in 1 CARTON (0093-9291-67) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength0.125MG
Approval Date:Aug 10, 2005TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength0.25MG
Approval Date:Aug 10, 2005TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength0.5MG
Approval Date:Aug 10, 2005TE:ABRLD:No

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