Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 007110
Company: MERCK
Company: MERCK
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CORTONE | CORTISONE ACETATE | 25MG/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
CORTONE | CORTISONE ACETATE | 50MG/ML | INJECTABLE;INJECTION | 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 |
---|---|---|---|---|---|---|---|
06/13/1950 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
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-23 | Manufacturing (CMC) |
Label is not available on this site. |
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08/26/1993 | SUPPL-21 | Labeling |
Label is not available on this site. |
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04/20/1994 | SUPPL-20 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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05/16/1989 | SUPPL-15 | Labeling |
Label is not available on this site. |
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12/09/1982 | SUPPL-14 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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03/04/1982 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/15/1979 | SUPPL-9 | Labeling |
Label is not available on this site. |