FDA Orange Book · active-ingredient family
Diflorasone diacetate
Diflorasone diacetate: 5 brands, 8 generics; first approved Aug 28, 1985; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 8 ANDA applications approved.
Brands (NDA)
5
Generics (ANDA)
8
Listed patents
0
Presentations
13
Brand (NDA) products
Originator applications
- PSORCONRLDTARO PHARMS NORTHNDA 0202051992
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.05% CREAM TOPICAL Discontinued — - PSORCONRLDPFIZERNDA 0192601985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.05% OINTMENT TOPICAL Discontinued — - PFIZERNDA 0192591985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.05% CREAM TOPICAL Discontinued — - PFIZERNDA 017741—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.05% CREAM TOPICAL Discontinued — - PFIZERNDA 017994—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.05% OINTMENT TOPICAL Discontinued —
Generic (ANDA) products (8)
Abbreviated applications
- DIFLORASONE DIACETATETHE J MOLNERANDA 2107532018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.05% OINTMENT TOPICAL Rx AB - DIFLORASONE DIACETATERISINGANDA 2074402017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.05% OINTMENT TOPICAL Rx AB - DIFLORASONE DIACETATESCIEGEN PHARMSANDA 2065722015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.05% OINTMENT TOPICAL Discontinued — - DIFLORASONE DIACETATEANI PHARMSANDA 0762632002
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.05% CREAM TOPICAL Discontinued — - DIFLORASONE DIACETATERSSUN PHARMA CANADAANDA 0755082000
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.05% CREAM TOPICAL Rx BX - DIFLORASONE DIACETATERSSUN PHARMA CANADAANDA 0753311999
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.05% OINTMENT TOPICAL Rx AB - DIFLORASONE DIACETATEAVONDALE PHARMSANDA 0753741999
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.05% OINTMENT TOPICAL Rx AB - DIFLORASONE DIACETATEAVONDALE PHARMSANDA 0751871998
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.05% CREAM 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
41 yr 7 mo ago
Most recent approval
8 yr 4 mo ago
Approvals span 1985–2018 across 13 FDA applications.
Brand (NDA) 538%
Generic (ANDA) 862%
Diflorasone diacetate: 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.
