Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090868
Company: MYLAN PHARMS INC
Company: MYLAN PHARMS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SIMVASTATIN | SIMVASTATIN | 5MG | TABLET;ORAL | Discontinued | None | No | No |
SIMVASTATIN | SIMVASTATIN | 10MG | TABLET;ORAL | Discontinued | None | No | No |
SIMVASTATIN | SIMVASTATIN | 20MG | TABLET;ORAL | Discontinued | None | No | No |
SIMVASTATIN | SIMVASTATIN | 40MG | TABLET;ORAL | Discontinued | None | No | No |
SIMVASTATIN | SIMVASTATIN | 80MG | 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 |
---|---|---|---|---|---|---|---|
06/08/2010 | 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 |
---|---|---|---|---|---|
11/14/2016 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
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05/01/2012 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
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01/11/2012 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |