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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 211542

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NDA 211542 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 211542

Tradename:	TEMAZEPAM
Applicant:	Alembic
Ingredient:	temazepam
Patents:	0

Pharmacology for NDA: 211542

Medical Subject Heading (MeSH) Categories for 211542

Anti-Anxiety Agents
GABA Modulators
Hypnotics and Sedatives

Suppliers and Packaging for NDA: 211542

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TEMAZEPAM	temazepam	CAPSULE;ORAL	211542	ANDA	Alembic Pharmaceuticals Limited	46708-379	46708-379-30	30 CAPSULE in 1 BOTTLE (46708-379-30)
TEMAZEPAM	temazepam	CAPSULE;ORAL	211542	ANDA	Alembic Pharmaceuticals Limited	46708-379	46708-379-31	100 CAPSULE in 1 BOTTLE (46708-379-31)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	7.5MG
Approval Date:	Nov 23, 2018	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	15MG
Approval Date:	Nov 23, 2018	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	22.5MG
Approval Date:	Nov 23, 2018	TE:	AB	RLD:	No

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