Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 007750
Company: MERCK
Company: MERCK
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CORTONE | CORTISONE ACETATE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
12/04/1950 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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 |
---|---|---|---|---|---|
03/01/1996 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
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08/18/1994 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/27/1993 | SUPPL-25 | Labeling |
Label is not available on this site. |
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11/30/1989 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
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05/16/1989 | SUPPL-18 | Labeling |
Label is not available on this site. |
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03/02/1982 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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02/01/1980 | SUPPL-13 | Labeling |
Label is not available on this site. |
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09/25/1979 | SUPPL-12 | Labeling |
Label is not available on this site. |
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08/01/1979 | SUPPL-11 | Labeling |
Label is not available on this site. |