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Details for New Drug Application (NDA): 018830

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NDA 018830 describes TAMBOCOR, which is a drug marketed by Cnty Line Pharms and is included in one NDA. It is available from one supplier. Additional details are available on the TAMBOCOR profile page.

The generic ingredient in TAMBOCOR is flecainide acetate. There are nine drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the flecainide acetate profile page.

Summary for NDA: 018830

Cnty Line Pharms
flecainide acetate
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 018830

Suppliers and Packaging for NDA: 018830

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
flecainide acetate
TABLET;ORAL 018830 NDA County Line Pharmaceuticals, LLC 43199-056 43199-056-01 100 TABLET in 1 BOTTLE (43199-056-01)
flecainide acetate
TABLET;ORAL 018830 NDA County Line Pharmaceuticals, LLC 43199-057 43199-057-01 100 TABLET in 1 BOTTLE (43199-057-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Oct 31, 1985TE:ABRLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength200MG
Approval Date:Oct 31, 1985TE:RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Jun 3, 1988TE:ABRLD:Yes

Expired Orange Book Patents for NDA: 018830

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cnty Line Pharms
flecainide acetate
TABLET;ORAL018830-004Aug 23, 19883,800,481► subscribe
Cnty Line Pharms
flecainide acetate
TABLET;ORAL018830-001Oct 31, 19853,900,481► subscribe
Cnty Line Pharms
flecainide acetate
TABLET;ORAL018830-003Jun 3, 19884,642,384► subscribe
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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.