APPLICATION
ANDA075203
TYPE
ANDA
ORIGINAL APPROVAL
2000-10-24
LATEST ACTION
2019-11-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
PROPAFENONE HYDROCHLORIDEDiscontinued
PROPAFENONE HYDROCHLORIDE 150MG · TABLET · ORAL
PROPAFENONE HYDROCHLORIDEDiscontinued
PROPAFENONE HYDROCHLORIDE 225MG · TABLET · ORAL
Approval history
2019-11-13Labeling · Supplement 17 · standardAP
2015-08-13Labeling · Supplement 15 · standardAP
2015-08-13Labeling · Supplement 12AP
2003-09-24Labeling · Supplement 5AP
2002-11-07Manufacturing (CMC) · Supplement 3AP
2002-05-24Labeling · Supplement 2AP
2002-02-19Manufacturing (CMC) · Supplement 1AP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.