Desloratadine
Desloratadine: 3 brands, 11 generics; first approved Dec 21, 2001; generic available.
Generic available: 11 ANDA applications approved.
Brand (NDA) products
- CLARINEXRLDORGANONNDA 02131220052 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET, ORALLY DISINTEGRATING ORAL Discontinued — 2.5MG TABLET, ORALLY DISINTEGRATING ORAL Discontinued — - CLARINEXRLDORGANON LLCNDA 0213002004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG/ML SOLUTION ORAL Discontinued — - ORGANONNDA 0211652001
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB
Generic (ANDA) products (11)
- DESLORATADINERSTAROANDA 2029362016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG/ML SOLUTION ORAL Rx — - DESLORATADINETAROANDA 2025922015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG/ML SOLUTION ORAL Discontinued — - DESLORATADINEAJENAT PHARMSANDA 0783552012
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB - DESLORATADINENATCO PHARMA USAANDA 0783512012
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB - DESLORATADINEPERRIGOANDA 0783612011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — - DESLORATADINEDR REDDYS LABS LTDANDA 0783652011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB - DESLORATADINECHARTWELL RXANDA 0783642010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — - DESLORATADINESUN PHARM INDSANDA 0783592010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — - DESLORATADINELUPIN PHARMSANDA 0783522010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB - DESLORATADINEREDDYSANDA 07836720102 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET, ORALLY DISINTEGRATING ORAL Rx — 5MG TABLET, ORALLY DISINTEGRATING ORAL Rx — - DESLORATADINEORBION PHARMSANDA 0783572010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL 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 2001–2016 across 14 FDA applications.
Desloratadine: 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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