Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021416
Company: GLAXOSMITHKLINE LLC
Company: GLAXOSMITHKLINE LLC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
RYTHMOL SR | PROPAFENONE HYDROCHLORIDE | 225MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
RYTHMOL SR | PROPAFENONE HYDROCHLORIDE | 325MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
RYTHMOL SR | PROPAFENONE HYDROCHLORIDE | 425MG | CAPSULE, EXTENDED RELEASE;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 |
---|---|---|---|---|---|---|---|
09/04/2003 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21416_rythmol_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21416ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-416_Rythmol.cfm |
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/2018/021416s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021416Orig1s015Ltr.pdf | |
07/11/2014 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/09/2013 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/14/2013 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021416s011lbl.pdf | |
04/13/2011 | SUPPL-10 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021416s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021416s010ltr.pdf | |
10/29/2010 | SUPPL-7 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021416s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021416s007ltr.pdf | |
09/13/2004 | SUPPL-1 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21416s001ltr.pdf |
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/2018/021416s015lbl.pdf | |
02/14/2013 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021416s011lbl.pdf | |
04/13/2011 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021416s010lbl.pdf | |
10/29/2010 | SUPPL-7 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021416s007lbl.pdf | |
09/04/2003 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21416_rythmol_lbl.pdf |