Halcinonide
Halcinonide: 6 brands, 3 generics; first approved Aug 12, 2019; generic available.
Generic available: 3 ANDA applications approved.
Brand (NDA) products
- SUN PHARM INDS INCNDA 017556-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.1% CREAM TOPICAL Rx AB - HALOGRLDWESTWOOD SQUIBBNDA 017818-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.025% CREAM TOPICAL Discontinued - - HALOGRLDBRISTOL MYERS SQUIBBNDA 018125-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.025% OINTMENT TOPICAL Discontinued - - HALOGRLDSUN PHARM INDS INCNDA 017824-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.1% OINTMENT TOPICAL Discontinued - - HALOGRLDSUN PHARM INDS INCNDA 017823-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.1% SOLUTION TOPICAL Rx AT - SUN PHARM INDS INCNDA 018234-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.1% CREAM TOPICAL Discontinued -
Generic (ANDA) products (3)
- HALCINONIDERSENCUBEANDA 2176712024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.1% SOLUTION TOPICAL Rx AT - HALCINONIDECHARTWELL RXANDA 2147232021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.1% CREAM TOPICAL Rx AB - HALCINONIDEMYLANANDA 2110272019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.1% CREAM TOPICAL Rx AB
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.
Approval history
Approvals span 2019–2024 across 9 FDA applications.
Halcinonide: 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.
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