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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

Tradename:
TAMBOCOR
Applicant:
Cnty Line Pharms
Ingredient:
flecainide acetate
Patents:0
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
TAMBOCOR
flecainide acetate
TABLET;ORAL 018830 NDA County Line Pharmaceuticals, LLC 43199-056 43199-056-01 100 TABLET in 1 BOTTLE (43199-056-01)
TAMBOCOR
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: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:RXDosage:TABLET;ORALStrength150MG
Approval Date:Jun 3, 1988TE:ABRLD: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
TAMBOCOR
flecainide acetate
TABLET;ORAL018830-002Oct 31, 19853,900,481► subscribe
Cnty Line Pharms
TAMBOCOR
flecainide acetate
TABLET;ORAL018830-003Jun 3, 19883,900,481► subscribe
Cnty Line Pharms
TAMBOCOR
flecainide acetate
TABLET;ORAL018830-003Jun 3, 19884,005,209► subscribe
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