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Generated: March 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 071620

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NDA 071620 describes TEMAZEPAM, which is a drug marketed by Actavis Elizabeth, Amneal Pharms, Duramed Pharms Barr, Mylan, Novel Labs Inc, Prinston Inc, Sandoz, Sun Pharm Industries, Usl Pharma, and Watson Labs, and is included in nineteen NDAs. It is available from thirty-six suppliers. Additional details are available on the TEMAZEPAM profile page.

The generic ingredient in TEMAZEPAM is temazepam. There are seven drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the temazepam profile page.
Summary for 071620
Applicant:Actavis Elizabeth
Formulation / Manufacturing:see details
Pharmacology for NDA: 071620
Medical Subject Heading (MeSH) Categories for 071620
Suppliers and Packaging for NDA: 071620
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TEMAZEPAM temazepam CAPSULE;ORAL 071620 ANDA Actavis Pharma, Inc. 0228-2076 N 0228-2076-50
TEMAZEPAM temazepam CAPSULE;ORAL 071620 ANDA Actavis Pharma, Inc. 0228-2076 N 0228-2076-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength30MG
Approval Date:Aug 7, 1987TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength15MG
Approval Date:Aug 7, 1987TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Argus Health
Federal Trade Commission

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