Loratadine; pseudoephedrine sulfate
Loratadine; pseudoephedrine sulfate: 2 brands, 7 generics; first approved Nov 27, 2002; generic available.
Generic available: 7 ANDA applications approved.
Brand (NDA) products
- BAYER HEALTHCARE LLCNDA 0196702002
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG;120MG TABLET, EXTENDED RELEASE ORAL OTC — - BAYER HEALTHCARE LLCNDA 0204702002
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG;240MG TABLET, EXTENDED RELEASE ORAL OTC —
Generic (ANDA) products (7)
- DR REDDYSANDA 2204482026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG;120MG TABLET, EXTENDED RELEASE ORAL OTC — - BIONPHARMAANDA 2180172024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG;240MG TABLET, EXTENDED RELEASE ORAL OTC — - SUN PHARM INDS LTDANDA 0765572004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG;240MG TABLET, EXTENDED RELEASE ORAL OTC — - PERRIGO PHARMA INTLANDA 0759892004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG;240MG TABLET, EXTENDED RELEASE ORAL OTC — - HERITAGE PHARMAANDA 0762082004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG;120MG TABLET, EXTENDED RELEASE ORAL Discontinued — - P AND LANDA 0757062003
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG;240MG TABLET, EXTENDED RELEASE ORAL OTC — - PERRIGO PHARMA INTLANDA 0760502003
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG;120MG TABLET, EXTENDED RELEASE ORAL OTC —
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 2002–2026 across 9 FDA applications.
Loratadine; pseudoephedrine sulfate: 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.
