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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 040626

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NDA 040626 describes PRIMIDONE, which is a drug marketed by Amneal Pharm, Chartwell Rx, Hikma Intl Pharms, Impax Labs, Lannett, Oxford Pharms, Pharmobedient, Rubicon Research, Tp Anda Holdings, and Watson Labs, and is included in eleven NDAs. It is available from twenty suppliers. Additional details are available on the PRIMIDONE profile page.

The generic ingredient in PRIMIDONE is primidone. There are seven drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the primidone profile page.

Summary for 040626

Tradename:	PRIMIDONE
Applicant:	Tp Anda Holdings
Ingredient:	primidone
Patents:	0

Medical Subject Heading (MeSH) Categories for 040626

Anticonvulsants

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Sep 29, 2005	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	250MG
Approval Date:	Sep 29, 2005	TE:	AB	RLD:	No

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