Details for New Drug Application (NDA): 040866

NDA 040866 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 040866

Tradename:	PRIMIDONE
Applicant:	Amneal Pharm
Ingredient:	primidone
Patents:	0

Pharmacology for NDA: 040866

Physiological Effect

Decreased Central Nervous System Disorganized Electrical Activity

Medical Subject Heading (MeSH) Categories for 040866

Anticonvulsants

Suppliers and Packaging for NDA: 040866

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PRIMIDONE	primidone	TABLET;ORAL	040866	ANDA	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8206	0615-8206-39	30 TABLET in 1 BLISTER PACK (0615-8206-39)
PRIMIDONE	primidone	TABLET;ORAL	040866	ANDA	AvKARE	42291-509	42291-509-01	100 TABLET in 1 BOTTLE (42291-509-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Apr 23, 2008	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	250MG
Approval Date:	Apr 23, 2008	TE:	AB	RLD:	No

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