Orange Book product · Brand (NDA)
XYZAL ALLERGY 24HR
LEVOCETIRIZINE DIHYDROCHLORIDE
At a glance
Jan 31, 2017
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 31, 2017
9 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
LEVOCETIRIZINE DIHYDROCHLORIDE
Strength
5MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 209089
Product number
001
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.
- 2017XYZAL ALLERGY 24HRBrand (NDA)
NDA 209090 · CHATTEM SANOFI
- 2008XYZALBrand (NDA)
NDA 022157 · CHATTEM SANOFI
- 2007XYZALBrand (NDA)
NDA 022064 · CHATTEM SANOFI
- 2024LEVOCETIRIZINE DIHYDROCHLORIDEGeneric (ANDA)
ANDA 204626 · IPCA LABS LTD
- 2021LEVOCETIRIZINE DIHYDROCHLORIDEGeneric (ANDA)
ANDA 211443 · APOTEX
- 2020LEVOCETIRIZINE DIHYDROCHLORIDEGeneric (ANDA)
ANDA 213513 · HETERO LABS LTD III
- 2019LEVOCETIRIZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 210914 · HETERO LABS LTD III
- 2019LEVOCETIRIZINE DIHYDROCHLORIDEGeneric (ANDA)
ANDA 211983 · PERRIGO R AND D
- 2018LEVOCETIRIZINE DIHYDROCHLORIDEGeneric (ANDA)
ANDA 211551 · SANKALP LIFECARE
- 2018LEVOCETIRIZINE DIHYDROCHLORIDEGeneric (ANDA)
ANDA 210375 · DR REDDYS
- 2017LEVOCETIRIZINE DIHYDROCHLORIDEGeneric (ANDA)
ANDA 204599 · CHARTWELL MOLECULAR
- 2016LEVOCETIRIZINE DIHYDROCHLORIDEGeneric (ANDA)
ANDA 204323 · US ANTIBIOTICS
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.
