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Serving leading biopharmaceutical companies globally:

Covington
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Medtronic
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Generated: December 12, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077194

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NDA 077194 describes CLONAZEPAM, which is a drug marketed by Barr, Par Pharm, Sun Pharm Inds Inc, Accord Hlthcare, Actavis Elizabeth, Apotex Inc, Mylan, Mylan Pharms Inc, Prinston Inc, Sandoz, Teva, and Watson Labs, and is included in fifteen NDAs. It is available from forty-six 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. Forty-eight suppliers are listed for this compound. Additional details are available on the clonazepam profile page.

Summary for 077194

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 077194

Ingredient-typeBenzodiazepines

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 0555-0094 0555-0094-96 10 BLISTER PACK in 1 CARTON (0555-0094-96) > 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
CLONAZEPAM clonazepam TABLET, ORALLY DISINTEGRATING;ORAL 077194 ANDA Teva Pharmaceuticals USA, Inc 0555-0095 0555-0095-96 10 BLISTER PACK in 1 CARTON (0555-0095-96) > 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

Summary for product number 001

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

Summary for product number 002

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

Summary 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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US Department of Justice
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