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| ACTONEL | RISEDRONATE SODIUM | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 03/27/1998 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Letter
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20835_Actonel.htm https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20835_Actonel.cfm |
Supplements
| 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)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020835s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020835Orig1s052ltr.pdf | |
| 10/22/2015 | SUPPL-49 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/08/2015 | SUPPL-48 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020835s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020835Orig1s048ltr.pdf | |
| 03/26/2015 | SUPPL-47 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020835s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020835Orig1s047ltr.pdf | |
| 12/02/2014 | SUPPL-46 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/19/2013 | SUPPL-45 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020835s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020835Orig1s045ltr.pdf | |
| 08/22/2011 | SUPPL-44 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020835s044ltr.pdf |
| 01/25/2011 | SUPPL-43 | REMS-Proposal |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020835s042s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020835s042,s043ltr.pdf | |
| 01/25/2011 | SUPPL-42 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020835s042s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020835s042,s043ltr.pdf | |
| 12/31/2009 | SUPPL-36 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020835s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020835s036ltr.pdf | |
| 07/23/2009 | SUPPL-35 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020835s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020835s035ltr.pdf | |
| 04/22/2008 | SUPPL-30 | Efficacy-New Dosing Regimen |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020835s029, s030ltr.pdf |
| 04/22/2008 | SUPPL-29 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020835s029, s030ltr.pdf |
| 07/24/2007 | SUPPL-28 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020835s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020835s028ltr.pdf | |
| 04/16/2007 | SUPPL-25 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020835s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020835s025ltr.pdf | |
| 08/11/2006 | SUPPL-23 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020835s022s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020835s022, 020835s023LTR.pdf | |
| 08/11/2006 | SUPPL-22 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020835s022s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020835s022, 020835s023LTR.pdf | |
| 09/12/2005 | SUPPL-20 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020835s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020835s020ltr.pdf | |
| 01/24/2006 | SUPPL-19 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020835s019, 021823s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020835s019_021823s002ltr.pdf | |
| 05/06/2005 | SUPPL-18 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020835s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020835s018ltr.pdf | |
| 02/24/2004 | SUPPL-14 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20835slr014_actionel_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20835slr014ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020835_S014_ACTONEL TABLETS.pdf | |
| 12/10/2002 | SUPPL-12 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020835_S012_ACTONEL.pdf |
| 11/05/2002 | SUPPL-11 | Manufacturing (CMC)-Packaging |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020835_S011_ACTONEL.pdf |
| 09/26/2002 | SUPPL-10 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020835_S010_ACTENOL.pdf |
| 05/17/2002 | SUPPL-9 | Efficacy-New Dosing Regimen |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20835s008ltr.pdf |
| 05/17/2002 | SUPPL-8 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/020835s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20835s008ltr.pdf | |
| 12/21/2001 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/02/2001 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/14/2000 | SUPPL-4 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20835s1s2s3s4lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20835s1-2-3-4ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20835S001_Actonel.cfm | |
| 04/14/2000 | SUPPL-3 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20835s1s2s3s4lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20835s1-2-3-4ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20835S001_Actonel.cfm | |
| 04/14/2000 | SUPPL-2 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20835s1s2s3s4lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20835s1-2-3-4ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20835S001_Actonel.cfm | |
| 04/14/2000 | SUPPL-1 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20835s1s2s3s4lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20835s1-2-3-4ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20835S001_Actonel.cfm |
| 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 |
ACTONEL
TABLET;ORAL; 35MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ACTONEL | RISEDRONATE SODIUM | 35MG | TABLET;ORAL | Prescription | Yes | AB | 020835 | APIL |
| RISEDRONATE SODIUM | RISEDRONATE SODIUM | 35MG | TABLET;ORAL | Prescription | No | AB | 090877 | APOTEX |
| RISEDRONATE SODIUM | RISEDRONATE SODIUM | 35MG | TABLET;ORAL | Prescription | No | AB | 200296 | AUROBINDO PHARMA LTD |
| RISEDRONATE SODIUM | RISEDRONATE SODIUM | 35MG | TABLET;ORAL | Prescription | No | AB | 203533 | MACLEODS PHARMS LTD |
| RISEDRONATE SODIUM | RISEDRONATE SODIUM | 35MG | TABLET;ORAL | Prescription | No | AB | 205280 | ORBION PHARMS |
| RISEDRONATE SODIUM | RISEDRONATE SODIUM | 35MG | TABLET;ORAL | Prescription | No | AB | 090886 | SUN PHARM |
| RISEDRONATE SODIUM | RISEDRONATE SODIUM | 35MG | TABLET;ORAL | Prescription | No | AB | 077132 | TEVA PHARMS USA |
TABLET;ORAL; 150MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ACTONEL | RISEDRONATE SODIUM | 150MG | TABLET;ORAL | Prescription | Yes | AB | 020835 | APIL |
| RISEDRONATE SODIUM | RISEDRONATE SODIUM | 150MG | TABLET;ORAL | Prescription | No | AB | 090877 | APOTEX |
| RISEDRONATE SODIUM | RISEDRONATE SODIUM | 150MG | TABLET;ORAL | Prescription | No | AB | 206768 | AUROBINDO PHARMA |
| RISEDRONATE SODIUM | RISEDRONATE SODIUM | 150MG | TABLET;ORAL | Prescription | No | AB | 090886 | SUN PHARM |
| RISEDRONATE SODIUM | RISEDRONATE SODIUM | 150MG | TABLET;ORAL | Prescription | No | AB | 079215 | TEVA PHARMS USA |