Orange Book product · Generic (ANDA)
LORATADINE AND PSEUDOEPHEDRINE SULFATE
LORATADINE; PSEUDOEPHEDRINE SULFATE
At a glance
May 14, 2024
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 14, 2024
2 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
LORATADINE; PSEUDOEPHEDRINE SULFATE
Strength
10MG;240MG
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
ANDA 218017
Product number
001
Marketing status
OTC
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of LORATADINE; PSEUDOEPHEDRINE SULFATE
- 2002CLARITIN-DBrand (NDA)
NDA 019670 · BAYER HEALTHCARE LLC
- 2002CLARITIN-D 24 HOURBrand (NDA)
NDA 020470 · BAYER HEALTHCARE LLC
- 2004LORATADINE AND PSEUDOEPHEDRINE SULFATEGeneric (ANDA)
ANDA 076557 · SUN PHARM INDS LTD
- 2004LORATADINE AND PSEUDOEPHEDRINE SULFATEGeneric (ANDA)
ANDA 075989 · PERRIGO PHARMA INTL
- 2004LORATADINE AND PSEUDOEPHEDRINE SULFATEGeneric (ANDA)
ANDA 076208 · HERITAGE PHARMA
- 2003LORATADINE AND PSEUDOEPHEDRINE SULFATEGeneric (ANDA)
ANDA 075706 · P AND L
- 2003LORATADINE AND PSEUDOEPHEDRINE SULFATEGeneric (ANDA)
ANDA 076050 · PERRIGO PHARMA INTL
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.
