Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020835
Company: APIL
Company: APIL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACTONEL | RISEDRONATE SODIUM | 30MG | TABLET;ORAL | Discontinued | None | Yes | No |
| ACTONEL | RISEDRONATE SODIUM | 5MG | TABLET;ORAL | Discontinued | None | Yes | No |
| ACTONEL | RISEDRONATE SODIUM | 35MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| ACTONEL | RISEDRONATE SODIUM | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| ACTONEL | RISEDRONATE SODIUM | 150MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/05/2019 | SUPPL-52 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020835s052lbl.pdf | |
| 04/08/2015 | SUPPL-48 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020835s048lbl.pdf | |
| 03/26/2015 | SUPPL-47 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020835s047lbl.pdf | |
| 04/19/2013 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020835s045lbl.pdf | |
| 01/25/2011 | SUPPL-43 | REMS-Proposal | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020835s042s043lbl.pdf | |
| 01/25/2011 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020835s042s043lbl.pdf | |
| 12/31/2009 | SUPPL-36 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020835s036lbl.pdf | |
| 07/23/2009 | SUPPL-35 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020835s035lbl.pdf | |
| 07/24/2007 | SUPPL-28 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020835s028lbl.pdf | |
| 04/16/2007 | SUPPL-25 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020835s025lbl.pdf | |
| 08/11/2006 | SUPPL-23 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020835s022s023lbl.pdf | |
| 08/11/2006 | SUPPL-22 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020835s022s023lbl.pdf | |
| 01/24/2006 | SUPPL-19 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020835s019, 021823s002lbl.pdf | |
| 09/12/2005 | SUPPL-20 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020835s020lbl.pdf | |
| 05/06/2005 | SUPPL-18 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020835s018lbl.pdf | |
| 02/24/2004 | SUPPL-14 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20835slr014_actionel_lbl.pdf | |
| 05/17/2002 | SUPPL-8 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/020835s008lbl.pdf | |
| 04/14/2000 | SUPPL-4 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20835s1s2s3s4lbl.pdf | |
| 04/14/2000 | SUPPL-3 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20835s1s2s3s4lbl.pdf | |
| 04/14/2000 | SUPPL-2 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20835s1s2s3s4lbl.pdf | |
| 04/14/2000 | SUPPL-1 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20835s1s2s3s4lbl.pdf |