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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 071026

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NDA 071026 describes OXAZEPAM, which is a drug marketed by Actavis Elizabeth, Am Therap, Epic Pharma Llc, Ivax Sub Teva Pharms, Leading, Mylan, Tp Anda Holdings, Watson Labs, Watson Labs Teva, Parke Davis, and Sun Pharm Industries, and is included in nineteen NDAs. It is available from five suppliers. Additional details are available on the OXAZEPAM profile page.

The generic ingredient in OXAZEPAM is oxazepam. There are eight drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the oxazepam profile page.

Summary for 071026

Tradename:	OXAZEPAM
Applicant:	Tp Anda Holdings
Ingredient:	oxazepam
Patents:	0

Pharmacology for NDA: 071026

Medical Subject Heading (MeSH) Categories for 071026

Anti-Anxiety Agents
GABA Modulators
Hypnotics and Sedatives

Suppliers and Packaging for NDA: 071026

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OXAZEPAM	oxazepam	CAPSULE;ORAL	071026	ANDA	TruPharma, LLC	52817-290	52817-290-10	100 CAPSULE in 1 BOTTLE (52817-290-10)
OXAZEPAM	oxazepam	CAPSULE;ORAL	071026	ANDA	TruPharma, LLC	52817-291	52817-291-10	100 CAPSULE in 1 BOTTLE (52817-291-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	30MG
Approval Date:	Aug 10, 1987	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	10MG
Approval Date:	Aug 10, 1987	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	15MG
Approval Date:	Aug 10, 1987	TE:	AB	RLD:	No

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