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Generated: April 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 083551

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NDA 083551 describes PRIMIDONE, which is a drug marketed by Amneal Pharm, Anda Repository, Dr Reddys Labs Ltd, Hikma Intl Pharms, Impax Labs, Lannett, Vintage Pharms, and Watson Labs, and is included in nine NDAs. It is available from sixteen 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. Seventeen suppliers are listed for this compound. Additional details are available on the primidone profile page.

Summary for 083551

Tradename:	PRIMIDONE
Applicant:	Watson Labs
Ingredient:	primidone
Patents:	0
Therapeutic Class:	Anticonvulsants
Formulation / Manufacturing:	see details

Pharmacology for NDA: 083551

Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Medical Subject Heading (MeSH) Categories for 083551

Anticonvulsants

Suppliers and Packaging for NDA: 083551

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PRIMIDONE	primidone	TABLET;ORAL	083551	ANDA	Actavis Pharma, Inc.	0591-5321	N	0591-5321-01
PRIMIDONE	primidone	TABLET;ORAL	083551	ANDA	Actavis Pharma, Inc.	0591-5321	N	0591-5321-10

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	250MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	No

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