Details for New Drug Application (NDA): 040862

NDA 040862 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 040862

Tradename:	PRIMIDONE
Applicant:	Dr Reddys Labs Ltd
Ingredient:	primidone
Patents:	0

Pharmacology for NDA: 040862

Physiological Effect

Decreased Central Nervous System Disorganized Electrical Activity

Medical Subject Heading (MeSH) Categories for 040862

Anticonvulsants

Suppliers and Packaging for NDA: 040862

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PRIMIDONE	primidone	TABLET;ORAL	040862	ANDA	Dr. Reddy's Laboratories Limited	55111-476	55111-476-01	100 TABLET in 1 BOTTLE (55111-476-01)
PRIMIDONE	primidone	TABLET;ORAL	040862	ANDA	Dr. Reddy's Laboratories Limited	55111-476	55111-476-05	500 TABLET in 1 BOTTLE (55111-476-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Oct 3, 2008	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	250MG
Approval Date:	Oct 3, 2008	TE:		RLD:	No

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