FDA Orange Book · active-ingredient family
Flurandrenolide
Flurandrenolide: 3 brands, 5 generics; first approved Apr 29, 1982; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 5 ANDA applications approved.
Brands (NDA)
3
Generics (ANDA)
5
Listed patents
0
Presentations
11
Brand (NDA) products
Originator applications
- CORDRAN SPRLDINA PHARMSNDA 012806—4 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.05% OINTMENT TOPICAL Discontinued — 0.05% CREAM TOPICAL Discontinued — 0.025% CREAM TOPICAL Discontinued — 0.025% OINTMENT TOPICAL Discontinued — - CORDRANRLDINA PHARMSNDA 013790—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.05% LOTION TOPICAL Discontinued — - ALMIRALLNDA 016455—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.004MG/SQ CM TAPE TOPICAL Rx —
Generic (ANDA) products (5)
Abbreviated applications
- FLURANDRENOLIDERSTELIGENTANDA 2078512016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.05% OINTMENT TOPICAL Rx — - FLURANDRENOLIDECHARTWELL RXANDA 2053432016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.05% LOTION TOPICAL Discontinued — - FLURANDRENOLIDERSPADAGIS ISRAELANDA 2071332016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.05% LOTION TOPICAL Rx — - FLURANDRENOLIDECHARTWELL RXANDA 2053422016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.05% CREAM TOPICAL Discontinued — - FLURANDRENOLIDEALPHARMA US PHARMSANDA 0872031982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.05% LOTION TOPICAL Discontinued —
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
45 yr 1 mo ago
Most recent approval
9 yr 11 mo ago
Approvals span 1982–2016 across 8 FDA applications.
Brand (NDA) 338%
Generic (ANDA) 563%
Flurandrenolide: 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.
