Last Updated: November 13, 2026

Details for New Drug Application (NDA): 071756

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NDA 071756 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 six suppliers. Additional details are available on the OXAZEPAM profile page.

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

Summary for 071756

Tradename:	OXAZEPAM
Applicant:	Epic Pharma Llc
Ingredient:	oxazepam
Patents:	0

Pharmacology for NDA: 071756

Medical Subject Heading (MeSH) Categories for 071756

Anti-Anxiety Agents
GABA Modulators
Hypnotics and Sedatives

Suppliers and Packaging for NDA: 071756

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OXAZEPAM	oxazepam	CAPSULE;ORAL	071756	ANDA	Epic Pharma, LLC	42806-572	42806-572-01	100 CAPSULE in 1 BOTTLE (42806-572-01)
OXAZEPAM	oxazepam	CAPSULE;ORAL	071756	ANDA	Epic Pharma, LLC	42806-573	42806-573-01	100 CAPSULE in 1 BOTTLE (42806-573-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	15MG
Approval Date:	Apr 19, 1988	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	10MG
Approval Date:	Apr 19, 1988	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	30MG
Approval Date:	Apr 19, 1988	TE:	AB	RLD:	No

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