Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076644
Company: MYLAN PHARMS INC
Company: MYLAN PHARMS INC
| 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. |
||
| 01/05/2016 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/26/2013 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/29/2013 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/01/2011 | SUPPL-11 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 03/20/2009 | SUPPL-9 | Labeling |
Label is not available on this site. |