Orange Book product · Brand (NDA)
CLARITIN
LORATADINE
At a glance
Nov 27, 2002
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 27, 2002
23 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
LORATADINE
Strength
1MG/ML
Dosage form
SYRUP
Route
ORAL
TE code
Not listed
Application
NDA 020641
Product number
002
Marketing status
OTC
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2008CLARITINBrand (NDA)
NDA 021952 · BAYER HEALTHCARE LLC
- 2006CLARITIN REDITABSBrand (NDA)
NDA 021993 · BAYER HEALTHCARE LLC
- 2006CHILDREN'S CLARITINBrand (NDA)
NDA 021891 · BAYER HEALTHCARE LLC
- 2005LORATADINEBrand (NDA)
NDA 021734 · SUN PHARMA CANADA
- 2004LORATADINEBrand (NDA)
NDA 021512 · PERRIGO
- 2003CLARITIN HIVES RELIEF REDITABBrand (NDA)
NDA 020704 · BAYER HEALTHCARE LLC
- 2002ALAVERTBrand (NDA)
NDA 021375 · FDN CONSUMER
- 2002CLARITINBrand (NDA)
NDA 019658 · BAYER HEALTHCARE LLC
- 2025LORATADINEGeneric (ANDA)
ANDA 215127 · CATALENT PHARMA
- 2024LORATADINEGeneric (ANDA)
ANDA 219223 · MARKSANS PHARMA
- 2023LORATADINEGeneric (ANDA)
ANDA 211718 · HETERO LABS LTD V
- 2023LORATADINEGeneric (ANDA)
ANDA 211900 · AUROBINDO PHARMA
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.
