Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 019151
Company: GLAXOSMITHKLINE LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RYTHMOL PROPAFENONE HYDROCHLORIDE 150MG TABLET;ORAL Discontinued None Yes No
RYTHMOL PROPAFENONE HYDROCHLORIDE 300MG TABLET;ORAL Discontinued None Yes No
RYTHMOL PROPAFENONE HYDROCHLORIDE 225MG TABLET;ORAL Discontinued None Yes No
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.

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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English