Orange Book product · Generic (ANDA)
LEVOCETIRIZINE DIHYDROCHLORIDE
LEVOCETIRIZINE DIHYDROCHLORIDE
At a glance
Nov 07, 2011
Approved
Generic (ANDA)
Application
AA
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 07, 2011
14 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
LEVOCETIRIZINE DIHYDROCHLORIDE
Strength
2.5MG/5ML
Dosage form
SOLUTION
Route
ORAL
TE code
AA
Application
ANDA 091263
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
Active-ingredient family
View full familyGeneric (ANDA) of LEVOCETIRIZINE DIHYDROCHLORIDE
- 2017XYZAL ALLERGY 24HRBrand (NDA)
NDA 209090 · CHATTEM SANOFI
- 2017XYZAL ALLERGY 24HRBrand (NDA)
NDA 209089 · 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
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.
