Last Updated: September 24, 2026

Details for New Drug Application (NDA): 070383

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NDA 070383 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 suppliers. Additional details are available on the TEMAZEPAM profile page.

The generic ingredient in TEMAZEPAM is temazepam. There is one drug master file entry for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the temazepam profile page.

Summary for 070383

Tradename:	TEMAZEPAM
Applicant:	Watson Labs
Ingredient:	temazepam
Patents:	0

Medical Subject Heading (MeSH) Categories for 070383

Anti-Anxiety Agents
GABA Modulators
Hypnotics and Sedatives

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	15MG
Approval Date:	Mar 23, 1987	TE:		RLD:	No

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