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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 075287

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NDA 075287 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 075287

Tradename:	PEMOLINE
Applicant:	Watson Labs
Ingredient:	pemoline
Patents:	0

Medical Subject Heading (MeSH) Categories for 075287

Central Nervous System Stimulants

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	18.75MG
Approval Date:	Jun 13, 2001	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	37.5MG
Approval Date:	Sep 18, 2000	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	75MG
Approval Date:	Sep 18, 2000	TE:		RLD:	No

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