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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 203482

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NDA 203482 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 203482

Tradename:	TEMAZEPAM
Applicant:	Amneal Pharms
Ingredient:	temazepam
Patents:	0

Pharmacology for NDA: 203482

Medical Subject Heading (MeSH) Categories for 203482

Anti-Anxiety Agents
GABA Modulators
Hypnotics and Sedatives

Suppliers and Packaging for NDA: 203482

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TEMAZEPAM	temazepam	CAPSULE;ORAL	203482	ANDA	Amneal Pharmaceuticals of New York LLC	53746-556	53746-556-01	100 CAPSULE in 1 BOTTLE (53746-556-01)
TEMAZEPAM	temazepam	CAPSULE;ORAL	203482	ANDA	Amneal Pharmaceuticals of New York LLC	53746-556	53746-556-05	500 CAPSULE in 1 BOTTLE (53746-556-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	7.5MG
Approval Date:	May 23, 2016	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	15MG
Approval Date:	May 23, 2016	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	22.5MG
Approval Date:	May 23, 2016	TE:		RLD:	No

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