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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 070920


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NDA 070920 describes TEMAZEPAM, which is a drug marketed by Actavis Elizabeth, Alembic, Alkem Labs Ltd, Amneal Pharms, Aurobindo Pharma Usa, Chartwell Rx, Duramed Pharms Barr, Novel Labs Inc, Prinston Inc, Sun Pharm Industries, Usl Pharma, and Watson Labs, and is included in twenty-one NDAs. It is available from twenty-four 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. Twenty-six suppliers are listed for this compound. Additional details are available on the temazepam profile page.
Summary for 070920
Tradename:TEMAZEPAM
Applicant:Aurobindo Pharma Usa
Ingredient:temazepam
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 070920

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:DISCNDosage:CAPSULE;ORALStrength7.5MG
Approval Date:May 21, 2010TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength22.5MG
Approval Date:Jun 12, 2009TE:RLD:No

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