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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 075030

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NDA 075030 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 075030

Tradename:	PEMOLINE
Applicant:	Teva Pharms
Ingredient:	pemoline
Patents:	0

Medical Subject Heading (MeSH) Categories for 075030

Central Nervous System Stimulants

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	37.5MG
Approval Date:	Jan 29, 1999	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	75MG
Approval Date:	Jan 29, 1999	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	18.75MG
Approval Date:	Feb 22, 2000	TE:		RLD:	No

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