Application 213513

Type
ANDA
Sponsor
HETERO LABS LTD III

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVOCETIRIZINE DIHYDROCHLORIDELEVOCETIRIZINE DIHYDROCHLORIDETABLET;ORAL5MGNoNo

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A213513-001LEVOCETIRIZINE DIHYDROCHLORIDELEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-29

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Goodmeds Levocetirizine Dihydrochloride 5mg 365 countLEVOCETIRIZINE DIHYDROCHLORIDE 5MGCabinet Health P.B.C.54f34304-952e-2f07-e063-6394a90a80ee2026-06-23WarningsExact identifier
Levocetirizine DihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEFarmacias De Similares TX LLC4ed17484-5609-d993-e063-6294a90a82a22026-04-06WarningsExact identifier
Curist Allergy ReliefLEVOCETIRIZINE DIHYDROCHLORIDE 5 MGLittle Pharma, Inc.f2a2a5bc-2efa-c550-e053-2a95a90a55ff2026-03-05WarningsExact identifier
Levocetirizine DihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDESportpharm LLC8c00c74f-4377-4f2c-943e-e55afa5a824f2026-02-14Exact identifier
ALLERGY RELIEFLEVOCETIRIZINE DIHYDROCHLORIDEYYBA CORP8ee69332-742d-4071-95df-84bc42e170e72025-12-03WarningsExact identifier
Curist Allergy ReliefLEVOCETIRIZINE DIHYDROCHLORIDE 5 MGLittle Pharma, Inc.feabf140-e283-dcd5-e053-6394a90a29172025-04-16WarningsExact identifier
Allery Relief 24HRALLERY RELIEF 24HRAllegiant Healthc523c210-b1c4-4049-9c72-2b31c9c931372024-04-02WarningsExact identifier
Levocetirizine DihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDECamber Consumer Care Incbe72dafb-62ae-40b2-874f-1d8920fad19d2020-11-30Exact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings Do not use If you have kidney disease if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing cetirizine Ask a doctor before use if you have ever had trouble urinating or emptying your bladder When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if have trouble urinating or emptying your bladder an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding, if breast-feeding: not recommended if pregnant: ask a health professional before use

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-5341Levocetirizine DihydrochlorideLevocetirizine DihydrochlorideA-S Medication SolutionsANDACurrent
50090-5341Levocetirizine DihydrochlorideLevocetirizine DihydrochlorideA-S Medication SolutionsANDACurrent
69230-321Levocetirizine DihydrochlorideLevocetirizine DihydrochlorideCamber Consumer CareANDACurrent
69230-321Levocetirizine DihydrochlorideLevocetirizine DihydrochlorideCamber Consumer Care IncANDACurrent
69230-321Levocetirizine DihydrochlorideLevocetirizine DihydrochlorideCamber Consumer CareANDACurrent
73581-201ALLERGY RELIEFLEVOCETIRIZINE DIHYDROCHLORIDEYYBA CORPANDACurrent