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Generated: July 20, 2017

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Details for New Drug Application (NDA): 071709

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NDA 071709 describes TEMAZEPAM, which is a drug marketed by Duramed Pharms Barr, Actavis Elizabeth, Mylan, Sandoz, Watson Labs, Novel Labs Inc, Sun Pharm Inds, Prinston Inc, Amneal Pharms, and Usl Pharma, and is included in nineteen NDAs. It is available from thirty-five 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-eight suppliers are listed for this compound. Additional details are available on the temazepam profile page.

Summary for NDA: 071709

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

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength30MG
Approval Date:Sep 29, 1988TE:RLD:No


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Serving 500+ biopharmaceutical companies globally:

Queensland Health
US Department of Justice
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AstraZeneca

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