Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076644
Company: NORVIUM BIOSCIENCE
Company: NORVIUM BIOSCIENCE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | 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 |
---|---|---|---|---|---|---|---|
11/09/2006 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/076644s000LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2005/076644Orig1s000.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/05/2016 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
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01/05/2016 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
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07/26/2013 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
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04/29/2013 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
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03/01/2011 | SUPPL-11 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
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03/20/2009 | SUPPL-9 | Labeling |
Label is not available on this site. |