Orange Book product · Generic (ANDA)
LORATADINE
LORATADINE
At a glance
Aug 20, 2004
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 20, 2004
22 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
LORATADINE
Strength
1MG/ML
Dosage form
SYRUP
Route
ORAL
TE code
Not listed
Application
ANDA 076805
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.
