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Last Updated: April 1, 2026

Details for New Drug Application (NDA): 071456

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NDA 071456 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 071456

Tradename:	TEMAZEPAM
Applicant:	Novel Labs Inc
Ingredient:	temazepam
Patents:	0

Pharmacology for NDA: 071456

Medical Subject Heading (MeSH) Categories for 071456

Anti-Anxiety Agents
GABA Modulators
Hypnotics and Sedatives

Suppliers and Packaging for NDA: 071456

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TEMAZEPAM	temazepam	CAPSULE;ORAL	071456	ANDA	Aphena Pharma Solutions - Tennessee, LLC	43353-312	43353-312-10	10 CAPSULE in 1 BOTTLE (43353-312-10)
TEMAZEPAM	temazepam	CAPSULE;ORAL	071456	ANDA	Aphena Pharma Solutions - Tennessee, LLC	43353-312	43353-312-15	15 CAPSULE in 1 BOTTLE (43353-312-15)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	15MG
Approval Date:	Apr 21, 1987	TE:	AB	RLD:	No

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