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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 040717

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NDA 040717 describes PRIMIDONE, which is a drug marketed by Amneal Pharm, Anda Repository, Carnegie, Dr Reddys Labs Ltd, Hikma Intl Pharms, Impax Labs, Lannett, Oxford Pharms, Rubicon, 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 040717

Tradename:	PRIMIDONE
Applicant:	Impax Labs
Ingredient:	primidone
Patents:	0

Medical Subject Heading (MeSH) Categories for 040717

Anticonvulsants

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Feb 12, 2008	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	250MG
Approval Date:	Feb 12, 2008	TE:		RLD:	No

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