Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020897
Company: JANSSEN PHARMS
Company: JANSSEN PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DITROPAN XL | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
| DITROPAN XL | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
| DITROPAN XL | OXYBUTYNIN CHLORIDE | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 12/16/1998 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20897lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20897ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20897.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/29/2021 | SUPPL-38 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020897s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020897Orig1s038ltr.pdf | |
| 09/12/2019 | SUPPL-37 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020897s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020897Orig1s037ltr.pdf | |
| 10/26/2018 | SUPPL-36 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020897s036lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020897Orig1s036ltr.pdf | |
| 09/13/2016 | SUPPL-35 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020897s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020897Orig1s035ltr.pdf | |
| 02/27/2015 | SUPPL-33 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020897s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020897Orig1s033ltr.pdf | |
| 08/01/2013 | SUPPL-32 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020897s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020897Orig1s032ltr.pdf | |
| 11/13/2012 | SUPPL-31 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020897s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020897Orig1s031ltr.pdf | |
| 03/23/2012 | SUPPL-30 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020897s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020897s030ltr.pdf | |
| 12/15/2011 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020897s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020897s029ltr.pdf | |
| 06/28/2011 | SUPPL-28 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020897s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020897s028ltr.pdf | |
| 07/13/2009 | SUPPL-24 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020897s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020897s024ltr.pdf | |
| 02/06/2008 | SUPPL-18 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017577s034,018211s017,020897s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020897s018ltr.pdf | |
| 06/30/2004 | SUPPL-13 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20897se8-013_Ditropan_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20897se8-013ltr.pdf | |
| 04/15/2003 | SUPPL-10 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17577se8-033,18211se8-016,20897slr010_ditropan_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17577se8-033,18211se8-016,20897slr010ltr.pdf | |
| 04/15/2003 | SUPPL-9 | Efficacy-New Patient Population |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17577se8-033,18211se8-016,20897slr010_ditropan_lbl.pdf | |
| 04/17/2000 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 09/29/1999 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/20/1999 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/28/1999 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/30/1999 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/25/1999 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/22/1999 | SUPPL-2 | Manufacturing (CMC)-Formulation |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020897_S002_DITROPAN_AP.pdf |
| 06/09/1999 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/29/2021 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020897s038lbl.pdf | |
| 09/12/2019 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020897s037lbl.pdf | |
| 10/26/2018 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020897s036lbledt.pdf | |
| 09/13/2016 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020897s035lbl.pdf | |
| 02/27/2015 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020897s033lbl.pdf | |
| 08/01/2013 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020897s032lbl.pdf | |
| 11/13/2012 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020897s031lbl.pdf | |
| 03/23/2012 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020897s030lbl.pdf | |
| 12/15/2011 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020897s029lbl.pdf | |
| 06/28/2011 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020897s028lbl.pdf | |
| 07/13/2009 | SUPPL-24 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020897s024lbl.pdf | |
| 02/06/2008 | SUPPL-18 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017577s034,018211s017,020897s018lbl.pdf | |
| 06/30/2004 | SUPPL-13 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20897se8-013_Ditropan_lbl.pdf | |
| 04/15/2003 | SUPPL-10 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17577se8-033,18211se8-016,20897slr010_ditropan_lbl.pdf | |
| 04/15/2003 | SUPPL-9 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17577se8-033,18211se8-016,20897slr010_ditropan_lbl.pdf | |
| 12/16/1998 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20897lbl.pdf |