Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020897
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 Prescription AB Yes No
DITROPAN XL OXYBUTYNIN CHLORIDE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription AB Yes No
DITROPAN XL OXYBUTYNIN CHLORIDE 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, EXTENDED RELEASE;ORAL Discontinued None Yes No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
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
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

DITROPAN XL

TABLET, EXTENDED RELEASE;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DITROPAN XL OXYBUTYNIN CHLORIDE 5MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 020897 JANSSEN PHARMS
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 207138 ACCORD HLTHCARE
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211655 AJANTA PHARMA LTD
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204010 AMNEAL PHARMS
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 076745 IMPAX PHARMS
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 076702 MYLAN
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 078503 OSMOTICA PHARM US
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 206121 UNIQUE PHARM LABS
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202332 ZYDUS PHARMS

TABLET, EXTENDED RELEASE;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DITROPAN XL OXYBUTYNIN CHLORIDE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 020897 JANSSEN PHARMS
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 207138 ACCORD HLTHCARE
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211655 AJANTA PHARMA LTD
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204010 AMNEAL PHARMS
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 076745 IMPAX PHARMS
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 076644 MYLAN PHARMS INC
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 078503 OSMOTICA PHARM US
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 206121 UNIQUE PHARM LABS
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202332 ZYDUS PHARMS

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