FDA Orange Book · active-ingredient family
Fludrocortisone acetate
Fludrocortisone acetate: 1 brand, 7 generics; first approved Mar 18, 2002; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 7 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
7
Listed patents
0
Presentations
8
Brand (NDA) products
Originator applications
- FLORINEFRLDCASPER PHARMA LLCNDA 010060—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.1MG TABLET ORAL Discontinued —
Generic (ANDA) products (7)
Abbreviated applications
- FLUDROCORTISONE ACETATEHIBROW HLTHCAREANDA 2203082026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.1MG TABLET ORAL Rx AB - FLUDROCORTISONE ACETATEZYDUS LIFESCIENCESANDA 2192512024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.1MG TABLET ORAL Rx AB - FLUDROCORTISONE ACETATECHARTWELL RXANDA 2160132022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.1MG TABLET ORAL Discontinued — - FLUDROCORTISONE ACETATENOVITIUM PHARMAANDA 2152792022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.1MG TABLET ORAL Rx AB - FLUDROCORTISONE ACETATEHIKMA PHARMSANDA 0913022011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.1MG TABLET ORAL Discontinued — - FLUDROCORTISONE ACETATEBARRANDA 0404252003
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.1MG TABLET ORAL Discontinued — - FLUDROCORTISONE ACETATERSIMPAX LABSANDA 0404312002
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.1MG TABLET ORAL Rx AB
Listed patents
Orange Book patent file
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.
Approval history
FDA approval span
First approval
24 yr 11 mo ago
Most recent approval
8 mo ago
Approvals span 2002–2026 across 8 FDA applications.
Brand (NDA) 113%
Generic (ANDA) 788%
Fludrocortisone acetate: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
