FDA Orange Book · active-ingredient family
Hydrocortisone sodium succinate
Hydrocortisone sodium succinate is approved as 1 brand and 27 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:SOLU-CORTEF · NDA 009866
1
Brand (NDA)
27
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SOLU-CORTEFRLD×4 | PHARMACIA AND UPJOHN | NDA 009866 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (27)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| HYDROCORTISONE SODIUM SUCCINATE | ZYDUS PHARMS | ANDA 217191 | AP | May 07, 2026 | |
| HYDROCORTISONE SODIUM SUCCINATE | APOTEX | ANDA 219856 | AP | Feb 05, 2026 | |
| HYDROCORTISONE SODIUM SUCCINATE | CIPLA | ANDA 214050 | AP | Sep 05, 2024 | |
| A-HYDROCORT | HOSPIRA | ANDA 040666 | — | Apr 06, 2006 | |
| A-HYDROCORT | ABBOTT | ANDA 089580 | — | Apr 11, 1989 | |
| A-HYDROCORT | ABBOTT | ANDA 089577 | — | Apr 11, 1989 | |
| A-HYDROCORT | ABBOTT | ANDA 089578 | — | Apr 11, 1989 | |
| A-HYDROCORT | ABBOTT | ANDA 089579 | — | Apr 11, 1989 | |
| HYDROCORTISONE SODIUM SUCCINATE | ABRAXIS PHARM | ANDA 088670 | — | Jun 08, 1984 | |
| HYDROCORTISONE SODIUM SUCCINATE | ABRAXIS PHARM | ANDA 088667 | — | Jun 08, 1984 | |
| HYDROCORTISONE SODIUM SUCCINATE | ABRAXIS PHARM | ANDA 088712 | — | Jun 08, 1984 | |
| HYDROCORTISONE SODIUM SUCCINATE | ABRAXIS PHARM | ANDA 088668 | — | Jun 08, 1984 | |
| HYDROCORTISONE SODIUM SUCCINATE | ABRAXIS PHARM | ANDA 088669 | — | Jun 08, 1984 | |
| HYDROCORTISONE SODIUM SUCCINATE | INTL MEDICATION | ANDA 087532 | — | Mar 19, 1982 | |
| A-HYDROCORT | ABBOTT | ANDA 085928 | — | Approved Prior to Jan 1, 1982 | |
| A-HYDROCORT | HOSPIRA | ANDA 085932 | — | Approved Prior to Jan 1, 1982 | |
| A-HYDROCORT | HOSPIRA | ANDA 085929 | — | Approved Prior to Jan 1, 1982 | |
| A-HYDROCORT | HOSPIRA | ANDA 085930 | — | Approved Prior to Jan 1, 1982 | |
| A-HYDROCORT | HOSPIRA | ANDA 085931 | — | Approved Prior to Jan 1, 1982 | |
| HYDROCORTISONE SODIUM SUCCINATE | BAXTER HLTHCARE | ANDA 087569 | — | Approved Prior to Jan 1, 1982 | |
| HYDROCORTISONE SODIUM SUCCINATE | BAXTER HLTHCARE | ANDA 086619 | — | Approved Prior to Jan 1, 1982 | |
| HYDROCORTISONE SODIUM SUCCINATE | BAXTER HLTHCARE | ANDA 087567 | — | Approved Prior to Jan 1, 1982 | |
| HYDROCORTISONE SODIUM SUCCINATE | BAXTER HLTHCARE | ANDA 087568 | — | Approved Prior to Jan 1, 1982 | |
| HYDROCORTISONE SODIUM SUCCINATE | WATSON LABS | ANDA 084748 | — | Approved Prior to Jan 1, 1982 | |
| HYDROCORTISONE SODIUM SUCCINATE×2 | WATSON LABS | ANDA 084737 | — | Approved Prior to Jan 1, 1982 | |
| HYDROCORTISONE SODIUM SUCCINATE | WATSON LABS | ANDA 084738 | — | Approved Prior to Jan 1, 1982 | |
| HYDROCORTISONE SODIUM SUCCINATE | WATSON LABS | ANDA 084747 | — | Approved Prior to Jan 1, 1982 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Hydrocortisone sodium succinate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
