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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 218261

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NDA 218261 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 218261

Tradename:	OXAZEPAM
Applicant:	Leading
Ingredient:	oxazepam
Patents:	0

Pharmacology for NDA: 218261

Medical Subject Heading (MeSH) Categories for 218261

Anti-Anxiety Agents
GABA Modulators
Hypnotics and Sedatives

Suppliers and Packaging for NDA: 218261

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OXAZEPAM	oxazepam	CAPSULE;ORAL	218261	ANDA	Leading Pharma, LLC	69315-911	69315-911-01	100 CAPSULE in 1 BOTTLE (69315-911-01)
OXAZEPAM	oxazepam	CAPSULE;ORAL	218261	ANDA	Leading Pharma, LLC	69315-912	69315-912-01	100 CAPSULE in 1 BOTTLE (69315-912-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	10MG
Approval Date:	Mar 3, 2025	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	15MG
Approval Date:	Mar 3, 2025	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	30MG
Approval Date:	Mar 3, 2025	TE:	AB	RLD:	No

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