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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 071813

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NDA 071813 describes OXAZEPAM, which is a drug marketed by Actavis Elizabeth, Am Therap, Epic Pharma Llc, Ivax Sub Teva Pharms, Mylan, Trupharma, Watson Labs, Watson Labs Teva, Parke Davis, and Sun Pharm Industries, and is included in twenty NDAs. It is available from four 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. Four suppliers are listed for this compound. Additional details are available on the oxazepam profile page.

Summary for 071813

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

Pharmacology for NDA: 071813

Medical Subject Heading (MeSH) Categories for 071813

Anti-Anxiety Agents
GABA Modulators
Hypnotics and Sedatives

Suppliers and Packaging for NDA: 071813

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OXAZEPAM	oxazepam	CAPSULE;ORAL	071813	ANDA	Aphena Pharma Solutions - Tennessee, LLC	43353-965	43353-965-30	30 CAPSULE in 1 BOTTLE (43353-965-30)
OXAZEPAM	oxazepam	CAPSULE;ORAL	071813	ANDA	Aphena Pharma Solutions - Tennessee, LLC	43353-965	43353-965-53	60 CAPSULE in 1 BOTTLE (43353-965-53)

Profile for product number 001

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

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