Drugs@FDA: FDA-Approved Drugs
Company: STRIDES PHARMA
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 |
---|---|---|---|---|---|---|---|
12/22/2009 | 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 |
---|---|---|---|---|---|
08/13/2024 | SUPPL-15 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
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06/06/2023 | SUPPL-14 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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06/06/2023 | SUPPL-13 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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08/11/2021 | SUPPL-12 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
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04/21/2021 | SUPPL-11 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
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01/15/2021 | SUPPL-10 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
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07/27/2016 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
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11/13/2015 | SUPPL-8 | REMS-Proposal |
Label is not available on this site. |
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09/27/2013 | SUPPL-7 | REMS-Modified |
Label is not available on this site. |
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08/01/2012 | SUPPL-5 | Labeling-Medication Guide, 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. |