← FDA DRUG APPROVALS

FDA NDA · NDA021416

RYTHMOL SR

Sponsor: GLAXOSMITHKLINE LLC

APPLICATION
NDA021416
TYPE
NDA
ORIGINAL APPROVAL
2003-09-04
LATEST ACTION
2018-11-02
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

RYTHMOL SR · ReferenceDiscontinued
PROPAFENONE HYDROCHLORIDE 325MG · CAPSULE, EXTENDED RELEASE · ORAL
RYTHMOL SR · ReferenceDiscontinued
PROPAFENONE HYDROCHLORIDE 425MG · CAPSULE, EXTENDED RELEASE · ORAL
RYTHMOL SR · ReferenceDiscontinued
PROPAFENONE HYDROCHLORIDE 225MG · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2018-11-02Labeling · Supplement 15 · standard — Label ↗AP
2014-07-11Manufacturing (CMC) · Supplement 13 · standardAP
2013-09-09Manufacturing (CMC) · Supplement 12 · standardAP
2013-02-14Labeling · Supplement 11 · unknown — Label ↗AP
2011-04-13Labeling · Supplement 10 · unknown — Label ↗AP
2010-10-29Labeling · Supplement 7 · standard — Letter ↗AP
2004-09-13Labeling · Supplement 1 · standard — Letter ↗AP
2003-09-04Type 3 - New Dosage Form · 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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