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 |
| 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 |