Drugs@FDA: FDA-Approved Drugs
Company: HIKMA INTL PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HYDROCORTISONE | HYDROCORTISONE | 20MG | TABLET;ORAL | Discontinued | None | No | No |
| HYDROCORTISONE | HYDROCORTISONE | 5MG | TABLET;ORAL | Discontinued | None | No | No |
| HYDROCORTISONE | HYDROCORTISONE | 10MG | 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 |
|---|---|---|---|---|---|---|---|
| 06/18/1973 | 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 |
|---|---|---|---|---|---|
| 06/28/2017 | SUPPL-46 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/28/2017 | SUPPL-45 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 06/28/2017 | SUPPL-43 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/13/2015 | SUPPL-42 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/28/2017 | SUPPL-41 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/23/2015 | SUPPL-40 | Labeling |
Label is not available on this site. |
||
| 07/15/2002 | SUPPL-36 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/16/2002 | SUPPL-35 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/01/2000 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/21/1999 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/01/1998 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/07/1997 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/08/1995 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 05/23/1994 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 04/22/1994 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/05/1991 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 04/03/1991 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/03/1991 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/07/1988 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/09/1990 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 10/14/1988 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/05/1986 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/14/1988 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/14/1988 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/13/1985 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/13/1985 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/13/1982 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/13/1982 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |