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Generated: September 20, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076421

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NDA 076421 describes FLECAINIDE ACETATE, which is a drug marketed by Sun Pharm Inds Ltd, Idt Australia Ltd, Amneal Pharm, Apotex Inc, West-ward Pharms Int, and Ani Pharms Inc, and is included in six NDAs. It is available from twelve suppliers. Additional details are available on the FLECAINIDE ACETATE profile page.

The generic ingredient in FLECAINIDE ACETATE is flecainide acetate. There are ten drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the flecainide acetate profile page.

Summary for NDA: 076421

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 076421

Suppliers and Packaging for NDA: 076421

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLECAINIDE ACETATE
flecainide acetate
TABLET;ORAL 076421 ANDA Ranbaxy Pharmaceuticals Inc. 63304-794 63304-794-01 100 TABLET in 1 BOTTLE, UNIT-DOSE (63304-794-01)
FLECAINIDE ACETATE
flecainide acetate
TABLET;ORAL 076421 ANDA Ranbaxy Pharmaceuticals Inc. 63304-795 63304-795-01 100 TABLET in 1 BOTTLE, UNIT-DOSE (63304-795-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Mar 28, 2003TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Mar 28, 2003TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Mar 28, 2003TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Cantor Fitzgerald
Colorcon
Accenture
Farmers Insurance
McKesson
Novartis
Julphar
Queensland Health
US Army
Covington

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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