Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077013
Company: NORVIUM BIOSCIENCE
Company: NORVIUM BIOSCIENCE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 10MG | TABLET;ORAL | Discontinued | None | No | No |
PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 20MG | TABLET;ORAL | Discontinued | None | No | No |
PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 40MG | TABLET;ORAL | Discontinued | None | No | No |
PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | 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 |
---|---|---|---|---|---|---|---|
10/23/2006 | 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 |
---|---|---|---|---|---|
06/18/2024 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
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08/18/2021 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
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06/04/2020 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
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12/28/2007 | SUPPL-2 | Labeling |
Label is not available on this site. |
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12/28/2007 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |