Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017109
Company: ROXANE
Company: ROXANE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PREDNISONE | PREDNISONE | 20MG | 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 |
---|---|---|---|---|---|---|---|
06/28/1974 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/14/1980 | SUPPL-10 | Labeling |
Label is not available on this site. |
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11/01/1979 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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11/27/1978 | SUPPL-8 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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09/21/1977 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |