Last Updated: May 3, 2026

Details for New Drug Application (NDA): 070564

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NDA 070564 describes TEMAZ, which is a drug marketed by Quantum Pharmics, 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-three NDAs. Additional details are available on the TEMAZ profile page.

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

Summary for 070564

Tradename:	TEMAZ
Applicant:	Quantum Pharmics
Ingredient:	temazepam
Patents:	0

Medical Subject Heading (MeSH) Categories for 070564

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:	Oct 15, 1985	TE:		RLD:	No

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