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 |
| 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 |