Orange Book product · Brand (NDA)
CLARITIN-D 24 HOUR
LORATADINE; PSEUDOEPHEDRINE SULFATE
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; PSEUDOEPHEDRINE SULFATE
Strength
10MG;240MG
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
NDA 020470
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.
- 2002CLARITIN-DBrand (NDA)
NDA 019670 · BAYER HEALTHCARE LLC
- 2024LORATADINE AND PSEUDOEPHEDRINE SULFATEGeneric (ANDA)
ANDA 218017 · BIONPHARMA
- 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.
