FDA.reportPublic FDA data

Application 211528

Type
ANDA
Sponsor
APOTEX INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVOCETIRIZINE DIHYDROCHLORIDELEVOCETIRIZINE DIHYDROCHLORIDESOLUTION;ORAL2.5MG/5MLNoNo

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 4 · 75 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LEVOCETIRIZINE DIHYDROCHLORIDELEVOCETIRIZINE DIHYDROCHLORIDEGlenmark Pharmaceuticals Inc., USA60ae7e0e-281c-40a3-a0d3-259b843ddaaa2026-09-09Warnings, Adverse reactionsName fallback
brand name: LEVOCETIRIZINE DIHYDROCHLORIDE
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEGolden State Medical Supply, Inc.163dcce7-4535-a596-e063-6394a90a634f2026-08-13Warnings, Adverse reactionsName fallback
brand name: levocetirizine dihydrochloride
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
ALLERGY RELIEFLEVOCETIRIZINE DIHYDROCHLORIDEAmazon.com Services LLC9ba39415-34af-49ca-b5cb-464e755179172026-08-12WarningsName fallback
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
good sense levocetirizineLEVOCETIRIZINE DIHYDROCHLORIDEL. Perrigo Company0b482364-a00a-4b95-975a-f403a3ae4d2e2026-07-13WarningsName fallback
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEDr. Reddy's Laboratories Inc.1f722b84-08de-7e6a-41ac-2c9d9bb9fb432026-06-04WarningsName fallback
brand name: levocetirizine dihydrochloride
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEBryant Ranch Prepack8274ca80-e7d3-4f4f-9901-cc5c589b4fef2026-05-21Warnings, Adverse reactionsName fallback
brand name: levocetirizine dihydrochloride
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEBryant Ranch Prepackbe58ca52-ab5d-4656-bfe0-bd57662359682026-05-15Warnings, Adverse reactionsName fallback
brand name: levocetirizine dihydrochloride
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
Levocetirizine DihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEFarmacias De Similares TX LLC4ed17484-5609-d993-e063-6294a90a82a22026-04-06WarningsName fallback
brand name: Levocetirizine Dihydrochloride
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEBryant Ranch Prepackc79d3668-5243-4627-ad2b-cc7c045df1202026-03-31Warnings, Adverse reactionsName fallback
brand name: levocetirizine dihydrochloride
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDENuCare Pharmaceuticals,Inc.c2dbf151-5b3d-5dfb-e053-2995a90a4c192026-03-25Warnings, Adverse reactionsName fallback
brand name: levocetirizine dihydrochloride
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
Levocetirizine DihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEA-S Medication Solutionsd8b4b326-8be1-4404-9db7-636d869331392026-03-24Warnings, Adverse reactionsName fallback
brand name: Levocetirizine Dihydrochloride
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
Xyzal Allergy 24HRLEVOCETIRIZINE DIHYDROCHLORIDEChattem, Inc.8be45c2a-1eca-4a00-81b9-f7babdbdcd412026-03-11WarningsName fallback
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
Levocetirizine DihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDESportpharm LLC8c00c74f-4377-4f2c-943e-e55afa5a824f2026-02-14Name fallback
brand name: Levocetirizine Dihydrochloride
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
Childrens Xyzal AllergyLEVOCETIRIZINE DIHYDROCHLORIDEChattem, Inc.a33f2704-d350-428b-b467-91f4775ce17f2026-02-05WarningsName fallback
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEKROGER COMPANYe47658af-e0f3-5765-f568-300ba407dc292026-01-20WarningsName fallback
brand name: levocetirizine dihydrochloride
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDECVS PHARMACYc8681ca3-27b4-6738-af72-599ff05f2ec82026-01-20WarningsName fallback
brand name: levocetirizine dihydrochloride
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEWalgreens Company766b8836-74b8-8af7-b900-b813b4fc175b2026-01-20WarningsName fallback
brand name: levocetirizine dihydrochloride
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
24HR Allergy ReliefLEVOCETIRIZINE DIHYDROCHLORIDELEADER/ Cardinal Health 110, Inc.6ba57f12-fd25-c4a6-ff2d-2955116f84c42026-01-20WarningsName fallback
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
Allergy ReliefLEVOCETIRIZINE DIHYDROCHLORIDEAlbertsons Companiese1a6932b-d076-6573-5b88-7b06c3a916812026-01-20WarningsName fallback
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDESAM'S WEST INCbb8d38b2-117a-fc6b-4ba0-0bc0188cbcd12026-01-19WarningsName fallback
brand name: levocetirizine dihydrochloride
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
56875ORIG2018-12-20