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Serving leading biopharmaceutical companies globally:

Queensland Health
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Generated: December 14, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202821

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NDA 202821 describes FLECAINIDE ACETATE, which is a drug marketed by Amneal Pharm, Ani Pharms Inc, Apotex Inc, Aurobindo Pharma Ltd, Idt Australia Ltd, Sun Pharm Inds Ltd, and West-ward Pharms Int, and is included in seven NDAs. It is available from fifteen 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. Sixteen suppliers are listed for this compound. Additional details are available on the flecainide acetate profile page.

Summary for 202821

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

Pharmacology for NDA: 202821

Medical Subject Heading (MeSH) Categories for 202821

Suppliers and Packaging for NDA: 202821

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLECAINIDE ACETATE flecainide acetate TABLET;ORAL 202821 ANDA Citron Pharma LLC 57237-063 57237-063-01 100 TABLET in 1 BOTTLE (57237-063-01)
FLECAINIDE ACETATE flecainide acetate TABLET;ORAL 202821 ANDA Citron Pharma LLC 57237-064 57237-064-01 100 TABLET in 1 BOTTLE (57237-064-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Nov 3, 2017TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Nov 3, 2017TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Nov 3, 2017TE: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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