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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 075678

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NDA 075678 describes PEMOLINE, which is a drug marketed by Actavis Elizabeth, Teva Pharms, Fosun Pharma, Mallinckrodt, Vintage Pharms, and Watson Labs, and is included in eight NDAs. Additional details are available on the PEMOLINE profile page.

The generic ingredient in PEMOLINE is pemoline. There are seven drug master file entries for this compound. Additional details are available on the pemoline profile page.

Summary for 075678

Tradename:	PEMOLINE
Applicant:	Actavis Elizabeth
Ingredient:	pemoline
Patents:	0

Medical Subject Heading (MeSH) Categories for 075678

Central Nervous System Stimulants

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, CHEWABLE;ORAL			Strength	37.5MG
Approval Date:	Jul 26, 2000	TE:		RLD:	No

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