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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. 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. Sixteen 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

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength100MG
Approval Date:Oct 31, 1985TE:RLD:No

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:DISCNDosage:TABLET;ORALStrength150MG
Approval Date:Jun 3, 1988TE:RLD:No

Expired Orange Book Patents for NDA: 018830

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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;ORAL018830-002Oct 31, 19853,900,481► subscribe
Cnty Line Pharms
flecainide acetate
TABLET;ORAL018830-003Jun 3, 19883,900,481► subscribe
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