Orange Book product · Brand (NDA)
XYZAL
LEVOCETIRIZINE DIHYDROCHLORIDE
At a glance
May 25, 2007
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 25, 2007
19 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
LEVOCETIRIZINE DIHYDROCHLORIDE
Strength
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 022064
Product number
001
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.
- 2017XYZAL ALLERGY 24HRBrand (NDA)
NDA 209090 · CHATTEM SANOFI
- 2017XYZAL ALLERGY 24HRBrand (NDA)
NDA 209089 · CHATTEM SANOFI
- 2008XYZALBrand (NDA)
NDA 022157 · 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.
