Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018211
Company: ORTHO MCNEIL JANSSEN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DITROPAN OXYBUTYNIN CHLORIDE 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SYRUP;ORAL Discontinued None Yes No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
11/29/1979 ORIG-1 Approval Type 3 - New Dosage Form 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
02/06/2008 SUPPL-17 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/2008/018211s017ltr.pdf
04/15/2003 SUPPL-16 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/2003/018211_s014&s016_DITROPAN TABLETS.pdf
11/06/2000 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

04/15/2003 SUPPL-14 Labeling 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/2003/018211_s014&s016_DITROPAN TABLETS.pdf
08/08/2000 SUPPL-13 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/12/1999 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

02/20/1998 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

02/21/1997 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

04/04/1996 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

01/26/1996 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

03/19/1991 SUPPL-6 Labeling

Label is not available on this site.

02/25/1988 SUPPL-5 Labeling

Label is not available on this site.

08/08/1986 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

06/11/1986 SUPPL-3 Labeling

Label is not available on this site.

03/13/2009 SUPPL-2 Labeling

Label is not available on this site.

05/22/1981 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/06/2008 SUPPL-17 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017577s034,018211s017,020897s018lbl.pdf
04/15/2003 SUPPL-16 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-14 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17577se8-033,18211se8-016,20897slr010_ditropan_lbl.pdf

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