Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 008506
Company: MERCK
Company: MERCK
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HYDROCORTONE | HYDROCORTISONE | 10MG | TABLET;ORAL | Discontinued | None | No | No |
| HYDROCORTONE | HYDROCORTISONE | 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 |
|---|---|---|---|---|---|---|---|
| 08/05/1952 | ORIG-1 | Approval | Type 2 New Active Ingredient and Type 4 New Combination | 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-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/23/1994 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/27/1993 | SUPPL-22 | Labeling |
Label is not available on this site. |
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| 05/16/1989 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 03/02/1982 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/06/1979 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 08/15/1979 | SUPPL-10 | Labeling |
Label is not available on this site. |