Drugs@FDA: FDA-Approved Drugs
Company: TEVA PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MYCOPHENOLATE MOFETIL | MYCOPHENOLATE MOFETIL | 500MG | TABLET;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 |
---|---|---|---|---|---|---|---|
05/04/2009 | 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 |
---|---|---|---|---|---|
08/13/2024 | SUPPL-18 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
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08/11/2021 | SUPPL-17 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
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04/21/2021 | SUPPL-16 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
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01/15/2021 | SUPPL-13 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
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10/30/2015 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
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11/13/2015 | SUPPL-9 | REMS-Proposal |
Label is not available on this site. |
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09/27/2013 | SUPPL-6 | Labeling-Medication Guide, REMS-Modified, Labeling-Package Insert |
Label is not available on this site. |
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07/25/2012 | 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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02/04/2010 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
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02/02/2010 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |