Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 012052
Company: MERCK
Company: MERCK
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HYDROCORTONE | HYDROCORTISONE SODIUM PHOSPHATE | EQ 50MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 06/08/1960 | 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 |
|---|---|---|---|---|---|
| 12/01/1997 | SUPPL-51 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/02/1997 | SUPPL-49 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 01/16/1997 | SUPPL-48 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/01/1996 | SUPPL-45 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/29/1996 | SUPPL-44 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/26/1993 | SUPPL-42 | Labeling |
Label is not available on this site. |
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| 09/10/1993 | SUPPL-41 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/06/1989 | SUPPL-40 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 03/08/1985 | SUPPL-34 | Labeling |
Label is not available on this site. |
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| 02/23/1984 | SUPPL-33 | Labeling |
Label is not available on this site. |
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| 01/15/1986 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 10/16/1981 | SUPPL-29 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 03/04/1982 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 01/14/1980 | SUPPL-27 | Labeling |
Label is not available on this site. |
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| 06/27/1977 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |