FDA Orange Book · active-ingredient family
Fludrocortisone acetate
Fludrocortisone acetate is approved as 1 brand and 7 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:FLORINEF · NDA 010060
1
Brand (NDA)
7
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| FLORINEFRLD | CASPER PHARMA LLC | NDA 010060 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (7)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| FLUDROCORTISONE ACETATE | HIBROW HLTHCARE | ANDA 220308 | AB | Feb 10, 2026 | |
| FLUDROCORTISONE ACETATE | ZYDUS LIFESCIENCES | ANDA 219251 | AB | Oct 16, 2024 | |
| FLUDROCORTISONE ACETATE | CHARTWELL RX | ANDA 216013 | — | Oct 27, 2022 | |
| FLUDROCORTISONE ACETATE | NOVITIUM PHARMA | ANDA 215279 | AB | May 31, 2022 | |
| FLUDROCORTISONE ACETATE | HIKMA PHARMS | ANDA 091302 | — | Jul 22, 2011 | |
| FLUDROCORTISONE ACETATE | BARR | ANDA 040425 | — | Jan 21, 2003 | |
| FLUDROCORTISONE ACETATE | IMPAX LABS | ANDA 040431 | AB | Mar 18, 2002 |
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.
Fludrocortisone acetate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
