Orange Book product · Brand (NDA)
CLARINEX
DESLORATADINE
At a glance
Jul 14, 2005
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 14, 2005
21 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
DESLORATADINE
Strength
2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
TE code
Not listed
Application
NDA 021312
Product number
002
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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.
- 2004CLARINEXBrand (NDA)
NDA 021300 · ORGANON LLC
- 2001CLARINEXBrand (NDA)
NDA 021165 · ORGANON
- 2016DESLORATADINEGeneric (ANDA)
ANDA 202936 · TARO
- 2015DESLORATADINEGeneric (ANDA)
ANDA 202592 · TARO
- 2012DESLORATADINEGeneric (ANDA)
ANDA 078355 · AJENAT PHARMS
- 2012DESLORATADINEGeneric (ANDA)
ANDA 078351 · NATCO PHARMA USA
- 2011DESLORATADINEGeneric (ANDA)
ANDA 078361 · PERRIGO
- 2011DESLORATADINEGeneric (ANDA)
ANDA 078365 · DR REDDYS LABS LTD
- 2010DESLORATADINEGeneric (ANDA)
ANDA 078364 · CHARTWELL RX
- 2010DESLORATADINEGeneric (ANDA)
ANDA 078359 · SUN PHARM INDS
- 2010DESLORATADINEGeneric (ANDA)
ANDA 078352 · LUPIN PHARMS
- 2010DESLORATADINEGeneric (ANDA)
ANDA 078367 · REDDYS
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.
