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QuintilesIMS
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US Department of Justice
US Army
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Generated: February 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201781

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NDA 201781 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 201781
Tradename:TEMAZEPAM
Applicant:Prinston Inc
Ingredient:temazepam
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 201781
Ingredient-typeBenzodiazepines
Medical Subject Heading (MeSH) Categories for 201781
Suppliers and Packaging for NDA: 201781
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TEMAZEPAM temazepam CAPSULE;ORAL 201781 ANDA Qualitest Pharmaceuticals 0603-5892 N 0603-5892-32
TEMAZEPAM temazepam CAPSULE;ORAL 201781 ANDA Qualitest Pharmaceuticals 0603-5892 N 0603-5892-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength7.5MG
Approval Date:Jun 4, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength15MG
Approval Date:Jun 4, 2015TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength22.5MG
Approval Date:Jun 4, 2015TE:ABRLD:No

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