Orange Book product · Brand (NDA)
CLARITIN
LORATADINE
At a glance
Jun 16, 2008
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 16, 2008
18 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
LORATADINE
Strength
10MG
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 021952
Product number
001
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.
- 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 020641 · BAYER HEALTHCARE LLC
- 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.
