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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 078581

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NDA 078581 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-five 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-seven suppliers are listed for this compound. Additional details are available on the temazepam profile page.

Summary for 078581

Tradename:	TEMAZEPAM
Applicant:	Sun Pharm Industries
Ingredient:	temazepam
Patents:	0

Pharmacology for NDA: 078581

Medical Subject Heading (MeSH) Categories for 078581

Anti-Anxiety Agents
GABA Modulators
Hypnotics and Sedatives

Suppliers and Packaging for NDA: 078581

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TEMAZEPAM	temazepam	CAPSULE;ORAL	078581	ANDA	Sun Pharmaceutical Industries, Inc.	53489-648	53489-648-01	100 CAPSULE in 1 BOTTLE, PLASTIC (53489-648-01)
TEMAZEPAM	temazepam	CAPSULE;ORAL	078581	ANDA	Sun Pharmaceutical Industries, Inc.	53489-648	53489-648-03	250 CAPSULE in 1 BOTTLE, PLASTIC (53489-648-03)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	7.5MG
Approval Date:	Sep 8, 2009	TE:	AB	RLD:	No

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