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Serving leading biopharmaceutical companies globally:

Fish and Richardson
AstraZeneca
Farmers Insurance
Daiichi Sankyo
Argus Health
Cipla
Express Scripts
Medtronic
Boehringer Ingelheim
Cantor Fitzgerald

Generated: December 11, 2017

DrugPatentWatch Database Preview

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 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 018830

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

Pharmacology for NDA: 018830

Medical Subject Heading (MeSH) Categories for 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 **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
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 **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
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 PharmsTAMBOCORflecainide acetateTABLET;ORAL018830-003Jun 3, 1988► Subscribe► Subscribe
Cnty Line PharmsTAMBOCORflecainide acetateTABLET;ORAL018830-002Oct 31, 1985► Subscribe► Subscribe
Cnty Line PharmsTAMBOCORflecainide acetateTABLET;ORAL018830-004Aug 23, 1988► Subscribe► Subscribe
Cnty Line PharmsTAMBOCORflecainide acetateTABLET;ORAL018830-003Jun 3, 1988► Subscribe► Subscribe
Cnty Line PharmsTAMBOCORflecainide acetateTABLET;ORAL018830-003Jun 3, 1988► Subscribe► Subscribe
Cnty Line PharmsTAMBOCORflecainide acetateTABLET;ORAL018830-001Oct 31, 1985► Subscribe► Subscribe
Cnty Line PharmsTAMBOCORflecainide acetateTABLET;ORAL018830-001Oct 31, 1985► Subscribe► Subscribe
Cnty Line PharmsTAMBOCORflecainide acetateTABLET;ORAL018830-002Oct 31, 1985► Subscribe► Subscribe
Cnty Line PharmsTAMBOCORflecainide acetateTABLET;ORAL018830-001Oct 31, 1985► Subscribe► Subscribe
Cnty Line PharmsTAMBOCORflecainide acetateTABLET;ORAL018830-002Oct 31, 1985► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Colorcon
UBS
Dow
Queensland Health
QuintilesIMS
Harvard Business School
Julphar
Accenture
Deloitte
Fuji

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