Last Updated: June 2, 2026

Details for New Drug Application (NDA): 071427

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NDA 071427 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 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 071427

Tradename:	TEMAZEPAM
Applicant:	Chartwell Rx
Ingredient:	temazepam
Patents:	0

Medical Subject Heading (MeSH) Categories for 071427

Anti-Anxiety Agents
GABA Modulators
Hypnotics and Sedatives

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	15MG
Approval Date:	Jan 12, 1988	TE:	AB	RLD:	No

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