APPLICATION
NDA019151
TYPE
NDA
ORIGINAL APPROVAL
1989-11-27
LATEST ACTION
2018-11-02
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
RYTHMOL · ReferenceDiscontinued
PROPAFENONE HYDROCHLORIDE 225MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
RYTHMOL · ReferenceDiscontinued
PROPAFENONE HYDROCHLORIDE 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
RYTHMOL · ReferenceDiscontinued
PROPAFENONE HYDROCHLORIDE 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
2014-07-11Manufacturing (CMC) · Supplement 13 · standardAP
2002-01-11Manufacturing (CMC) · Supplement 10 · standardAP
2000-12-21Manufacturing (CMC) · Supplement 8 · standardAP
2000-07-14Manufacturing (CMC) · Supplement 7 · standardAP
1999-09-24Manufacturing (CMC) · Supplement 6 · standardAP
1997-03-19Labeling · Supplement 4 · standardAP
1993-11-23Manufacturing (CMC) · Supplement 3 · standardAP
1992-11-20Manufacturing (CMC) · Supplement 1 · standardAP
1989-11-27Type 1 - New Molecular Entity · Original · standardAP
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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