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Last Updated: December 15, 2025

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-one 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-three 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

Medical Subject Heading (MeSH) Categories for 070920

Anti-Anxiety Agents
GABA Modulators
Hypnotics and Sedatives

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	30MG
Approval Date:	Jul 10, 1986	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	7.5MG
Approval Date:	May 21, 2010	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	22.5MG
Approval Date:	Jun 12, 2009	TE:		RLD:	No

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