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Serving leading biopharmaceutical companies globally:

US Department of Justice
Johnson and Johnson

Generated: December 14, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075423

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NDA 075423 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 075423

Formulation / Manufacturing:see details

Pharmacology for NDA: 075423


Medical Subject Heading (MeSH) Categories for 075423

Suppliers and Packaging for NDA: 075423

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLONAZEPAM clonazepam TABLET;ORAL 075423 ANDA Caraco Pharmaceutical Laboratories, Ltd. 57664-273 57664-273-08 100 TABLET in 1 BOTTLE (57664-273-08)
CLONAZEPAM clonazepam TABLET;ORAL 075423 ANDA Caraco Pharmaceutical Laboratories, Ltd. 57664-273 57664-273-18 1000 TABLET in 1 BOTTLE (57664-273-18)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG
Approval Date:Apr 27, 2001TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Apr 27, 2001TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Apr 27, 2001TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

US Department of Justice
Argus Health
Queensland Health

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