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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017577
Company: JANSSEN PHARMS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DITROPAN OXYBUTYNIN CHLORIDE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No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
07/16/1975 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/22/2012 SUPPL-38 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017577s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017577s038ltr.pdf
12/15/2011 SUPPL-37 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017577s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017577s037ltr.pdf
08/08/2011 SUPPL-36 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017577s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017577s036ltr.pdf
07/13/2009 SUPPL-35 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017577s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017577s035ltr.pdf
02/06/2008 SUPPL-34 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/2008/017577s034ltr.pdf
04/15/2003 SUPPL-33 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
Review (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 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/017577_s032&s033_DITROPAN TABS.pdf
04/15/2003 SUPPL-32 Efficacy-Labeling Change With Clinical Data Label (PDF)
Review (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/nda/2003/017577_s032&s033_DITROPAN TABS.pdf
02/20/1998 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.
11/13/1997 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.
07/09/1996 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.
05/31/1996 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.
12/26/1991 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.
03/19/1991 SUPPL-24 Labeling

Label is not available on this site.
11/27/1990 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.
02/10/1989 SUPPL-21 Labeling

Label is not available on this site.
04/29/1988 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.
02/25/1988 SUPPL-19 Labeling

Label is not available on this site.
10/23/1986 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.
08/08/1986 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.
06/11/1986 SUPPL-16 Labeling

Label is not available on this site.
06/19/1985 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.
01/07/1983 SUPPL-13 Manufacturing (CMC)-Packaging

Label is not available on this site.
01/07/1983 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.
01/07/1983 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.
09/20/1982 SUPPL-10 Labeling

Label is not available on this site.
12/22/1980 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.
06/25/1979 SUPPL-8 Labeling

Label is not available on this site.
12/05/1977 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.
04/01/1977 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.
10/21/1976 SUPPL-4 Labeling

Label is not available on this site.
03/01/1977 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.
04/02/1976 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.
04/16/1976 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
03/22/2012 SUPPL-38 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017577s038lbl.pdf
12/15/2011 SUPPL-37 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017577s037lbl.pdf
08/08/2011 SUPPL-36 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017577s036lbl.pdf
07/13/2009 SUPPL-35 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017577s035lbl.pdf
02/06/2008 SUPPL-34 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017577s034,018211s017,020897s018lbl.pdf
04/15/2003 SUPPL-33 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17577se8-033,18211se8-016,20897slr010_ditropan_lbl.pdf
04/15/2003 SUPPL-32 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17577se8-033,18211se8-016,20897slr010_ditropan_lbl.pdf
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