Last Updated: October 26, 2026

Details for New Drug Application (NDA): 078147

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NDA 078147 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 is one drug master file entry for this compound. Nine suppliers are listed for this compound. Additional details are available on the zaleplon profile page.

Summary for 078147

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	5MG
Approval Date:	Nov 25, 2008	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	10MG
Approval Date:	Nov 25, 2008	TE:		RLD:	No

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