Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 009866
Company: PHARMACIA AND UPJOHN
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 | AP | 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 |
|---|---|---|---|---|---|
| 06/05/2024 | SUPPL-121 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/009866s121lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/009866Orig1s121ltr.pdf | |
| 07/10/2024 | SUPPL-120 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/009866Orig1s120lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/009866Orig1s120ltr.pdf | |
| 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 |
|---|---|---|---|---|---|
| 07/10/2024 | SUPPL-120 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/009866Orig1s120lbl.pdf | |
| 06/05/2024 | SUPPL-121 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/009866s121lbl.pdf | |
| 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 |
SOLU-CORTEF
INJECTABLE;INJECTION; EQ 100MG BASE/VIAL
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| HYDROCORTISONE SODIUM SUCCINATE | HYDROCORTISONE SODIUM SUCCINATE | EQ 100MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 219856 | APOTEX |
| HYDROCORTISONE SODIUM SUCCINATE | HYDROCORTISONE SODIUM SUCCINATE | EQ 100MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 214050 | CIPLA |
| HYDROCORTISONE SODIUM SUCCINATE | HYDROCORTISONE SODIUM SUCCINATE | EQ 100MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 217191 | ZYDUS PHARMS |
| SOLU-CORTEF | HYDROCORTISONE SODIUM SUCCINATE | EQ 100MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AP | 009866 | PHARMACIA AND UPJOHN |