Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090419
Company: APOTEX CORP
Company: APOTEX CORP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MYCOPHENOLATE MOFETIL | MYCOPHENOLATE MOFETIL | 250MG | CAPSULE;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 |
---|---|---|---|---|---|---|---|
04/22/2009 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/06/2015 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
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11/13/2015 | SUPPL-9 | REMS-Modified |
Label is not available on this site. |
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10/06/2015 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
09/27/2013 | SUPPL-7 | Labeling-Package Insert, REMS-Modified |
Label is not available on this site. |
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08/31/2012 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
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09/25/2012 | SUPPL-4 | REMS-Proposal |
Label is not available on this site. |
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04/16/2010 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
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04/15/2010 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |