Drugs@FDA: FDA-Approved Drugs
Company: WATSON LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HYDROCORTISONE ACETATE | HYDROCORTISONE ACETATE | 25MG/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 |
|---|---|---|---|---|---|---|---|
| 02/27/1979 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/19/1999 | SUPPL-68 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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| 02/02/1999 | SUPPL-67 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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| 06/09/1998 | SUPPL-66 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/16/1997 | SUPPL-65 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/03/1996 | SUPPL-64 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/30/1994 | SUPPL-63 | Labeling |
Label is not available on this site. |
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| 02/24/1994 | SUPPL-62 | Labeling |
Label is not available on this site. |
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| 10/29/1992 | SUPPL-61 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/26/1993 | SUPPL-60 | Bioequivalence |
Label is not available on this site. |
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| 04/01/1991 | SUPPL-59 | Labeling |
Label is not available on this site. |
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| 05/22/1992 | SUPPL-58 | Labeling |
Label is not available on this site. |
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| 11/15/1989 | SUPPL-57 | Labeling |
Label is not available on this site. |
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| 02/11/1991 | SUPPL-56 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/11/1991 | SUPPL-55 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/30/1992 | SUPPL-54 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/23/1988 | SUPPL-53 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/23/1988 | SUPPL-52 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/23/1988 | SUPPL-51 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/23/1988 | SUPPL-50 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/16/1986 | SUPPL-47 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/27/1983 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/30/1982 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |