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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 040586

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NDA 040586 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 040586

Tradename:	PRIMIDONE
Applicant:	Oxford Pharms
Ingredient:	primidone
Patents:	0

Pharmacology for NDA: 040586

Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Medical Subject Heading (MeSH) Categories for 040586

Anticonvulsants

Suppliers and Packaging for NDA: 040586

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PRIMIDONE	primidone	TABLET;ORAL	040586	ANDA	Oxford Pharmaceuticals, LLC	69584-684	69584-684-10	100 TABLET in 1 BOTTLE, PLASTIC (69584-684-10)
PRIMIDONE	primidone	TABLET;ORAL	040586	ANDA	Oxford Pharmaceuticals, LLC	69584-684	69584-684-50	500 TABLET in 1 BOTTLE, PLASTIC (69584-684-50)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Feb 24, 2005	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	250MG
Approval Date:	Feb 24, 2005	TE:	AB	RLD:	No

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