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Serving hundreds of leading biopharmaceutical companies globally:

Generated: April 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078095

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NDA 078095 describes ZALEPLON, which is a drug marketed by Aurobindo Pharma, Cipla Ltd, Hikma Pharms, Mylan, Orchid Hlthcare, Teva Pharms, Unichem, Upsher-smith Labs, and West-ward Pharms Int, and is included in ten NDAs. It is available from thirteen 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. Fifteen suppliers are listed for this compound. Additional details are available on the zaleplon profile page.

Summary for 078095

Tradename:	ZALEPLON
Applicant:	Upsher-smith Labs
Ingredient:	zaleplon
Patents:	0
Therapeutic Class:	Sedatives/Hypnotics
Formulation / Manufacturing:	see details

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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