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FDA NDA · NDA018830

TAMBOCOR

Sponsor: ALVOGEN

APPLICATION
NDA018830
TYPE
NDA
ORIGINAL APPROVAL
1985-10-31
LATEST ACTION
2016-09-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

TAMBOCOR · ReferenceDiscontinued
FLECAINIDE ACETATE 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
TAMBOCOR · ReferenceDiscontinued
FLECAINIDE ACETATE 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
TAMBOCOR · ReferenceDiscontinued
FLECAINIDE ACETATE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
TAMBOCORDiscontinued
FLECAINIDE ACETATE 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2016-09-22Manufacturing (CMC) · Supplement 24 · standard — Letter ↗AP
2000-04-28Manufacturing (CMC) · Supplement 20 · standardAP
1999-09-03Manufacturing (CMC) · Supplement 19 · standardAP
1985-10-31Type 1 - New Molecular Entity · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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