Orange Book product · Generic (ANDA)
FLUDROCORTISONE ACETATE
FLUDROCORTISONE ACETATE
At a glance
Oct 16, 2024
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 16, 2024
1 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
FLUDROCORTISONE ACETATE
Strength
0.1MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 219251
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of FLUDROCORTISONE ACETATE
- —FLORINEFBrand (NDA)
NDA 010060 · CASPER PHARMA LLC
- 2026FLUDROCORTISONE ACETATEGeneric (ANDA)
ANDA 220308 · HIBROW HLTHCARE
- 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.
