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McKinsey
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Dow
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Covington

Generated: April 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 071175

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NDA 071175 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 twenty-eight 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-one suppliers are listed for this compound. Additional details are available on the temazepam profile page.
Summary for 071175
Tradename:TEMAZEPAM
Applicant:Sun Pharm Industries
Ingredient:temazepam
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 071175
Ingredient-typeBenzodiazepines
Medical Subject Heading (MeSH) Categories for 071175
Suppliers and Packaging for NDA: 071175
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TEMAZEPAM temazepam CAPSULE;ORAL 071175 ANDA Sun Pharmaceutical Industries, Inc. 53489-649 N 53489-649-10
TEMAZEPAM temazepam CAPSULE;ORAL 071175 ANDA Sun Pharmaceutical Industries, Inc. 53489-649 N 53489-649-05

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength30MG
Approval Date:Jul 10, 1986TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength22.5MG
Approval Date:Sep 14, 2009TE:ABRLD:No

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