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Generated: May 26, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 083551

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

Summary for NDA: 083551

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details

Pharmacology for NDA: 083551

Physiological EffectDecreased Central Nervous System Disorganized Electrical Activity

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 0591-5321-01 100 TABLET in 1 BOTTLE, PLASTIC (0591-5321-01)
PRIMIDONE
primidone
 TABLET;ORAL 083551 ANDA Actavis Pharma, Inc. 0591-5321 0591-5321-10 1000 TABLET in 1 BOTTLE, PLASTIC (0591-5321-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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