Rythmol Sr

NDA 21416, held by Glaxosmithkline LLC. Propafenone Hydrochloride.

As of Nov 14, 2026, NDA 21416 (Rythmol Sr), held by Glaxosmithkline LLC, was first approved by FDA on Sep 4, 2003, with 7 approved supplements and 0 published complete response letters.

First approved: Sep 4, 2003
Review: Standard
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Sep 4, 2003	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Products

3 strengths and forms


Rythmol Sr225MG · capsule, extended release;oral	Propafenone Hydrochloride	DiscontinuedReference drug
Rythmol Sr325MG · capsule, extended release;oral	Propafenone Hydrochloride	DiscontinuedReference drug
Rythmol Sr425MG · capsule, extended release;oral	Propafenone Hydrochloride	DiscontinuedReference drug

All 8 submissions, including labeling and manufacturing supplements


Nov 2, 2018	Supplement 15Labeling · Standard review	Approved	Letter Label
Jul 11, 2014	Supplement 13Manufacturing · Standard review	Approved	None posted
Sep 9, 2013	Supplement 12Manufacturing · Standard review	Approved	None posted
Feb 14, 2013	Supplement 11Labeling	Approved	Label
Apr 13, 2011	Supplement 10Labeling	Approved	Letter Label
Oct 29, 2010	Supplement 7Labeling · Standard review	Approved	Letter Label
Sep 13, 2004	Supplement 1Labeling · Standard review	Approved	Letter
Sep 4, 2003	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21416
Drugs@FDA: Overview at FDA
Company: GlaxoSmithKline LLC

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters