Orange Book product · Generic (ANDA)
LORATADINE
LORATADINE
At a glance
Mar 12, 2019
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 12, 2019
7 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
LORATADINE
Strength
10MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
ANDA 207569
Product number
001
Marketing status
OTC
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of LORATADINE
- 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 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
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.
