Orange Book product · Brand (NDA)
CLARINEX
DESLORATADINE
At a glance
Dec 21, 2001
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 21, 2001
24 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
DESLORATADINE
Strength
5MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 021165
Product number
001
Marketing status
RX
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.
- 2005CLARINEXBrand (NDA)
NDA 021312 · ORGANON
- 2004CLARINEXBrand (NDA)
NDA 021300 · ORGANON LLC
- 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.
