Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076745
Company: IMPAX PHARMS
Company: IMPAX PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 10MG | 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/2006/076745s000LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2006/076745Orig1s000.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/02/2015 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/02/2015 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
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| 08/29/2013 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
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| 07/19/2010 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
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| 05/09/2007 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |