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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 077239

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NDA 077239 describes ZALEPLON, which is a drug marketed by Aurobindo Pharma, Chartwell Molecular, Hikma, Hikma Pharms, Natco Pharma, Orbion Pharms, Teva Pharms, Unichem, and Upsher Smith Labs, and is included in ten NDAs. It is available from nine suppliers. Additional details are available on the ZALEPLON profile page.

The generic ingredient in ZALEPLON is zaleplon. There are twelve drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the zaleplon profile page.

Summary for 077239

Tradename:	ZALEPLON
Applicant:	Teva Pharms
Ingredient:	zaleplon
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	5MG
Approval Date:	Jun 6, 2008	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	10MG
Approval Date:	Jun 6, 2008	TE:		RLD:	No

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