Orange Book product · Generic (ANDA)
LEVOCETIRIZINE DIHYDROCHLORIDE
LEVOCETIRIZINE DIHYDROCHLORIDE
At a glance
Apr 29, 2020
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 29, 2020
6 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
LEVOCETIRIZINE DIHYDROCHLORIDE
Strength
5MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
ANDA 213513
Product number
001
Marketing status
OTC
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of LEVOCETIRIZINE DIHYDROCHLORIDE
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- 2008XYZALBrand (NDA)
NDA 022157 · CHATTEM SANOFI
- 2007XYZALBrand (NDA)
NDA 022064 · CHATTEM SANOFI
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ANDA 204626 · IPCA LABS LTD
- 2021LEVOCETIRIZINE DIHYDROCHLORIDEGeneric (ANDA)
ANDA 211443 · APOTEX
- 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.
