Orange Book product · Generic (ANDA)
LEVOCETIRIZINE HYDROCHLORIDE
LEVOCETIRIZINE DIHYDROCHLORIDE
At a glance
Apr 01, 2019
Approved
Generic (ANDA)
Application
AA
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 01, 2019
7 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
LEVOCETIRIZINE DIHYDROCHLORIDE
Strength
2.5MG/5ML
Dosage form
SOLUTION
Route
ORAL
TE code
AA
Application
ANDA 210914
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of LEVOCETIRIZINE DIHYDROCHLORIDE
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NDA 022157 · CHATTEM SANOFI
- 2007XYZALBrand (NDA)
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ANDA 211443 · APOTEX
- 2020LEVOCETIRIZINE DIHYDROCHLORIDEGeneric (ANDA)
ANDA 213513 · 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.
