An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 019151
Company: GLAXOSMITHKLINE LLC

Products on NDA 019151

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RYTHMOL	PROPAFENONE HYDROCHLORIDE	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
RYTHMOL	PROPAFENONE HYDROCHLORIDE	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
RYTHMOL	PROPAFENONE HYDROCHLORIDE	225MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019151

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/27/1989	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/02/2018	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019151s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019151Orig1s015Ltr.pdf
07/11/2014	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
03/20/2013	SUPPL-12	Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019151s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019151Orig1s012ltr.pdf
01/11/2002	SUPPL-10	Manufacturing (CMC)-Control		Label is not available on this site.
12/05/2002	SUPPL-9	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19151slr005slr009ltr.pdf
12/21/2000	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
07/14/2000	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
09/24/1999	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
12/05/2002	SUPPL-5	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19151slr005slr009ltr.pdf
03/19/1997	SUPPL-4	Labeling		Label is not available on this site.
11/23/1993	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
12/23/1997	SUPPL-2	Efficacy-New Indication	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/19151.pdf
11/20/1992	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 019151

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/02/2018	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019151s015lbl.pdf
03/20/2013	SUPPL-12	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019151s012lbl.pdf

Top