FDA Orange Book · active-ingredient family
Loratadine
Loratadine: 9 brands, 38 generics; first approved Nov 27, 2002; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 38 ANDA applications approved.
Brands (NDA)
9
Generics (ANDA)
38
Listed patents
0
Presentations
52
Brand (NDA) products
Originator applications
- BAYER HEALTHCARE LLCNDA 0219522008
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL OTC — - BAYER HEALTHCARE LLCNDA 0219932006
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET, ORALLY DISINTEGRATING ORAL OTC — - BAYER HEALTHCARE LLCNDA 02189120062 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET, CHEWABLE ORAL OTC — 10MG TABLET, CHEWABLE ORAL OTC — - LORATADINERLDSUN PHARMA CANADANDA 0217342005
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML SUSPENSION ORAL Discontinued — - BAYER HEALTHCARE LLCNDA 02070420032 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET, ORALLY DISINTEGRATING ORAL OTC — 10MG TABLET, ORALLY DISINTEGRATING ORAL OTC — - BAYER HEALTHCARE LLCNDA 02064120022 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML SYRUP ORAL OTC — 1MG/ML SYRUP ORAL Discontinued — - BAYER HEALTHCARE LLCNDA 01965820022 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL OTC — 10MG TABLET ORAL OTC — - LORATADINEPERRIGONDA 0215122004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - FDN CONSUMERNDA 0213752002
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET, ORALLY DISINTEGRATING ORAL OTC —
Generic (ANDA) products (38)
Abbreviated applications
- LORATADINECATALENT PHARMAANDA 2151272025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Discontinued — - LORATADINEMARKSANS PHARMAANDA 2192232024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL OTC — - LORATADINEHETERO LABS LTD VANDA 2117182023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL OTC — - LORATADINEAUROBINDO PHARMAANDA 2119002023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL OTC — - LORATADINEHETERO LABS LTD IIIANDA 2104092021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML SYRUP ORAL OTC — - LORATADINEUNIQUE PHARMANDA 2146842021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL OTC — - LORATADINEINSTAPILLANDA 2132942020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET, ORALLY DISINTEGRATING ORAL OTC — - LORATADINEINSTAPILLANDA 2127952020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET, ORALLY DISINTEGRATING ORAL OTC — - LORATADINERUBICON RESEARCHANDA 2142802020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET, ORALLY DISINTEGRATING ORAL OTC — - LORATADINEONESOURCEANDA 2119262020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Discontinued — - LORATADINEGRANULESANDA 2107222019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL OTC — - LORATADINEPERRIGO PHARMA INTLANDA 2100332019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET, CHEWABLE ORAL OTC — - LORATADINEADAPTISANDA 2075692019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL OTC — - LORATADINEBIONPHARMAANDA 2025382018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL OTC — - LORATADINEAUROBINDO PHARMA LTDANDA 2089312018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML SYRUP ORAL OTC — - LORATADINESUN PHARMANDA 21008820182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET, CHEWABLE ORAL OTC — 10MG TABLET, CHEWABLE ORAL OTC — - LORATADINEAUROBINDO PHARMA LTDANDA 2083142018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL OTC — - LORATADINEAUROBINDO PHARMA LTDANDA 2084772018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET, ORALLY DISINTEGRATING ORAL OTC — - LORATADINEMARKSANS PHARMAANDA 2062142016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL OTC — - LORATADINETAROANDA 2018652015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML SYRUP ORAL OTC — - LORATADINEPHARMOBEDIENTANDA 0784472011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - LORATADINEALLIEDANDA 0757902008
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - SUN PHARM INDS LTDANDA 0771532007
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET, ORALLY DISINTEGRATING ORAL OTC — - LORATADINELANNETT CO INCANDA 0774212006
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML SYRUP ORAL OTC — - LORATADINEAPOTEXANDA 0764712006
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL OTC — - LORATADINEPHARM ASSOCANDA 0755652004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML SYRUP ORAL Discontinued — - LORATADINEPERRIGOANDA 0757282004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML SYRUP ORAL OTC — - LORATADINERANBAXY LABS LTDANDA 0765292004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML SYRUP ORAL Discontinued — - LORATADINETAROANDA 0768052004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML SYRUP ORAL OTC — - LORATADINEWOCKHARDT BIO AGANDA 0758152004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML SYRUP ORAL OTC — - LORATADINEPERRIGOANDA 0763012004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL OTC — - LORATADINETEVAANDA 0755052003
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML SYRUP ORAL Discontinued — - LORATADINEACTAVIS LABS FL INCANDA 0759902003
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET, ORALLY DISINTEGRATING ORAL Discontinued — - LORATADINEPERRIGO PHARMA INTLANDA 0760112003
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET, ORALLY DISINTEGRATING ORAL OTC — - LORATADINEMYLANANDA 0761542003
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL OTC — - LORATADINESUN PHARM INDS LTDANDA 0761342003
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL OTC — - LORATADINEGLAXOSMITHKLINEANDA 0758222003
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET, ORALLY DISINTEGRATING ORAL Discontinued — - LORATADINEPLD ACQUISITIONS LLCANDA 0752092003
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL OTC —
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
24 yr 3 mo ago
Most recent approval
1 yr 6 mo ago
Approvals span 2002–2025 across 47 FDA applications.
Brand (NDA) 919%
Generic (ANDA) 3881%
Loratadine: 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.
