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Generated: November 13, 2018

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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 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:TAMBOCOR
Applicant:Cnty Line Pharms
Ingredient:flecainide acetate
Patents:0
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)

Profile 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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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

Profile for product number 002

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

Profile 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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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 US Patents for NDA 018830

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cnty Line Pharms TAMBOCOR flecainide acetate TABLET;ORAL 018830-003 Jun 3, 1988 ➤ Try a Free Trial ➤ Try a Free Trial
Cnty Line Pharms TAMBOCOR flecainide acetate TABLET;ORAL 018830-004 Aug 23, 1988 ➤ Try a Free Trial ➤ Try a Free Trial
Cnty Line Pharms TAMBOCOR flecainide acetate TABLET;ORAL 018830-001 Oct 31, 1985 ➤ Try a Free Trial ➤ Try a Free Trial
Cnty Line Pharms TAMBOCOR flecainide acetate TABLET;ORAL 018830-002 Oct 31, 1985 ➤ Try a Free Trial ➤ Try a Free Trial
Cnty Line Pharms TAMBOCOR flecainide acetate TABLET;ORAL 018830-002 Oct 31, 1985 ➤ Try a Free Trial ➤ Try a Free Trial
Cnty Line Pharms TAMBOCOR flecainide acetate TABLET;ORAL 018830-001 Oct 31, 1985 ➤ Try a Free Trial ➤ Try a Free Trial
Cnty Line Pharms TAMBOCOR flecainide acetate TABLET;ORAL 018830-004 Aug 23, 1988 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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