FDA Orange Book · active-ingredient family
Alclometasone dipropionate
Alclometasone dipropionate: 2 brands, 6 generics; first approved Dec 14, 1982; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 6 ANDA applications approved.
Brands (NDA)
2
Generics (ANDA)
6
Listed patents
0
Presentations
8
Brand (NDA) products
Originator applications
Generic (ANDA) products (6)
Abbreviated applications
- ALCLOMETASONE DIPROPIONATEGLENMARK PHARMS LTDANDA 0792272009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.05% OINTMENT TOPICAL Discontinued — - ALCLOMETASONE DIPROPIONATEGLENMARK PHARMS LTDANDA 0790612009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.05% CREAM TOPICAL Discontinued — - ALCLOMETASONE DIPROPIONATESUN PHARMA CANADAANDA 0765872005
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.05% CREAM TOPICAL Rx AB - ALCLOMETASONE DIPROPIONATERSFOUGERA PHARMSANDA 0768842005
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.05% OINTMENT TOPICAL Rx AB - ALCLOMETASONE DIPROPIONATERSFOUGERA PHARMSANDA 0769732005
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.05% CREAM TOPICAL Rx AB - ALCLOMETASONE DIPROPIONATESUN PHARMA CANADAANDA 0767302004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.05% OINTMENT TOPICAL 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
44 yr 4 mo ago
Most recent approval
17 yr 4 mo ago
Approvals span 1982–2009 across 8 FDA applications.
Brand (NDA) 225%
Generic (ANDA) 675%
Alclometasone dipropionate: 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.
