Drugs@FDA: FDA-Approved Drugs
Company: PHARMACIA AND UPJOHN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SOLU-CORTEF | HYDROCORTISONE SODIUM SUCCINATE | EQ 100MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | None | Yes | Yes |
SOLU-CORTEF | HYDROCORTISONE SODIUM SUCCINATE | EQ 250MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | None | Yes | Yes |
SOLU-CORTEF | HYDROCORTISONE SODIUM SUCCINATE | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | None | Yes | Yes |
SOLU-CORTEF | HYDROCORTISONE SODIUM SUCCINATE | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
04/27/1955 | ORIG-1 | Approval | Type 2 - New Active Ingredient | 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 |
---|---|---|---|---|---|
12/20/2023 | SUPPL-119 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/009866s119lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/009866Orig1s119ltr.pdf | |
05/27/2021 | SUPPL-115 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/009866s115lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/09866Orig1s115; 11856Orig1s136; 11757Origs120ltr.pdf | |
11/21/2019 | SUPPL-113 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/009866s113lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/009866Orig1s113ltr.pdf | |
02/25/2016 | SUPPL-108 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/08/2016 | SUPPL-105 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/009866s98_105lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/008697Orig1s032,s033,009866Orig1s098,s105ltr.pdf | |
07/03/2014 | SUPPL-104 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/009866s104lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/009866Orig1s104ltr.pdf | |
06/24/2014 | SUPPL-103 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/09/2014 | SUPPL-102 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/22/2014 | SUPPL-101 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/28/2014 | SUPPL-99 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/08/2016 | SUPPL-98 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/009866s98_105lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/008697Orig1s032,s033,009866Orig1s098,s105ltr.pdf | |
09/27/2013 | SUPPL-97 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/08/2013 | SUPPL-96 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/04/2014 | SUPPL-95 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/06/2014 | SUPPL-92 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/23/2015 | SUPPL-90 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/16/2010 | SUPPL-80 | Manufacturing (CMC) |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/009866s080lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/009866s080ltr.pdf | |
09/01/2009 | SUPPL-79 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/009866s77s79lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/009866s077s079ltr.pdf | |
09/01/2009 | SUPPL-77 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/009866s77s79lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/009866s077s79ltr.pdf | |
10/21/2002 | SUPPL-72 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/04/2000 | SUPPL-71 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/25/1999 | SUPPL-70 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
09/15/1994 | SUPPL-67 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/25/1994 | SUPPL-65 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
12/06/1994 | SUPPL-62 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
12/28/1993 | SUPPL-61 | Labeling |
Label is not available on this site. |
||
04/01/1991 | SUPPL-59 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
01/16/1990 | SUPPL-57 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/29/1990 | SUPPL-56 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
05/13/1988 | SUPPL-55 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/02/1987 | SUPPL-54 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
07/23/1987 | SUPPL-52 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
07/24/1985 | SUPPL-51 | Labeling |
Label is not available on this site. |
||
03/22/1989 | SUPPL-50 | Labeling |
Label is not available on this site. |
||
12/15/1981 | SUPPL-47 | Labeling |
Label is not available on this site. |
||
12/15/1981 | SUPPL-46 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
04/14/1980 | SUPPL-45 | Labeling |
Label is not available on this site. |
||
09/24/1979 | SUPPL-44 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
06/18/1979 | SUPPL-43 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
12/20/2023 | SUPPL-119 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/009866s119lbl.pdf | |
05/27/2021 | SUPPL-115 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/009866s115lbl.pdf | |
11/21/2019 | SUPPL-113 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/009866s113lbl.pdf | |
09/08/2016 | SUPPL-105 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/009866s98_105lbl.pdf | |
09/08/2016 | SUPPL-98 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/009866s98_105lbl.pdf | |
07/03/2014 | SUPPL-104 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/009866s104lbl.pdf | |
06/16/2010 | SUPPL-80 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/009866s080lbl.pdf |
09/01/2009 | SUPPL-79 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/009866s77s79lbl.pdf | |
09/01/2009 | SUPPL-77 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/009866s77s79lbl.pdf |