Drugs@FDA: FDA-Approved Drugs
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DITROPAN | OXYBUTYNIN CHLORIDE | 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP;ORAL | Discontinued | None | Yes | No |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. |
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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. |
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03/12/1999 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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02/20/1998 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/21/1997 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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04/04/1996 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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01/26/1996 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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03/19/1991 | SUPPL-6 | Labeling |
Label is not available on this site. |
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02/25/1988 | SUPPL-5 | Labeling |
Label is not available on this site. |
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08/08/1986 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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06/11/1986 | SUPPL-3 | Labeling |
Label is not available on this site. |
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03/13/2009 | SUPPL-2 | Labeling |
Label is not available on this site. |
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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 |