Orange Book product · Brand (NDA)
FLORINEF
FLUDROCORTISONE ACETATE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
FLUDROCORTISONE ACETATE
Strength
0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 010060
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2026FLUDROCORTISONE ACETATEGeneric (ANDA)
ANDA 220308 · HIBROW HLTHCARE
- 2024FLUDROCORTISONE ACETATEGeneric (ANDA)
ANDA 219251 · ZYDUS LIFESCIENCES
- 2022FLUDROCORTISONE ACETATEGeneric (ANDA)
ANDA 216013 · CHARTWELL RX
- 2022FLUDROCORTISONE ACETATEGeneric (ANDA)
ANDA 215279 · NOVITIUM PHARMA
- 2011FLUDROCORTISONE ACETATEGeneric (ANDA)
ANDA 091302 · HIKMA PHARMS
- 2003FLUDROCORTISONE ACETATEGeneric (ANDA)
ANDA 040425 · BARR
- 2002FLUDROCORTISONE ACETATEGeneric (ANDA)
ANDA 040431 · IMPAX LABS
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.
