Orange Book product · Generic (ANDA)
LEVOCETIRIZINE DIHYDROCHLORIDE
LEVOCETIRIZINE DIHYDROCHLORIDE
At a glance
Sep 17, 2013
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 17, 2013
12 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
LEVOCETIRIZINE DIHYDROCHLORIDE
Strength
5MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 202046
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)
NDA 022064 · CHATTEM SANOFI
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ANDA 204626 · IPCA LABS LTD
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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.
