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 2 of 4 · 75 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDETarget Corporation7e933c85-96b0-b103-e26a-1aa8a1ded58e2026-01-19WarningsName fallback
brand name: levocetirizine dihydrochloride
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEHEBb13ab6fc-4fec-c870-2c5f-b5e31dec722a2026-01-19WarningsName fallback
brand name: levocetirizine dihydrochloride
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEDr. Reddy's Laboratories Inc.fb0a3619-9d5b-5c58-82f3-31f031672f332026-01-19WarningsName fallback
brand name: levocetirizine dihydrochloride
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
Levocetirizine DihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEWalmart Inc.82da5fa1-3633-2c48-32b9-d15482f308a12026-01-19WarningsName fallback
brand name: Levocetirizine Dihydrochloride
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
Levocetirizine DihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDENorthwind Health Company, LLCf2b458d6-ac10-0fed-e053-2a95a90a0f9c2026-01-01Warnings, Adverse reactionsName fallback
brand name: Levocetirizine Dihydrochloride
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDENorthwind Health Company, LLCdae403cd-b6fc-7c50-e053-2995a90a95e32026-01-01Warnings, Adverse reactionsName fallback
brand name: levocetirizine dihydrochloride
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDERite Aid Corporationfafc8149-d59a-1253-ae79-f33a088e37692025-12-10WarningsName fallback
brand name: levocetirizine dihydrochloride
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEBJWC (Berkley & Jensen / BJ'S)0216f644-767c-ae88-f48f-cd29ac1547ed2025-12-10WarningsName fallback
brand name: levocetirizine dihydrochloride
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEChain Drug Marketing Association INC61fb8bef-d868-adee-3237-d3268d603ba62025-12-10WarningsName fallback
brand name: levocetirizine dihydrochloride
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
Allergy ReliefLEVOCETIRIZINE DIHYDROCHLORIDEAMERISOURCEBERGEN DRUG CORPORATIONfdf54de3-16a9-3b28-b4c4-d745322b3d3c2025-12-10WarningsName fallback
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEUnited Natural Foods, Inc. dba UNFI5036170d-7eeb-65a8-8473-7d98aeb51ee42025-12-10WarningsName fallback
brand name: levocetirizine dihydrochloride
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEScieGen Pharmaceuticals, Inc.bd7fe481-dfe7-4dfd-aa05-6e2318a9234e2025-10-16Warnings, Adverse reactionsName fallback
brand name: levocetirizine dihydrochloride
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
Levocetirizine DihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDECamber Pharmaceuticals, Inc.dd407f8f-140d-489f-b8c5-f6602d87e2472025-10-10Warnings, Adverse reactionsName fallback
brand name: Levocetirizine Dihydrochloride
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
allergy reliefLEVOCETIRIZINE DIHYDROCHLORIDERite Aid Corporationc6f826a4-cb8d-4a9f-99cc-5041f65801ca2025-10-09WarningsName fallback
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
Levocetirizine DihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEWestminster Pharmaceuticals, LLC85dcd6c0-7fb2-40b3-b07f-93bab169011d2025-09-30Warnings, Adverse reactionsName fallback
brand name: Levocetirizine Dihydrochloride
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
Levocetirizine DihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEBryant Ranch Prepackb7bbffcb-5f56-4735-998a-eadd07dfa2cb2025-09-17Warnings, Adverse reactionsName fallback
brand name: Levocetirizine Dihydrochloride
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
LEVOCETIRIZINE DIHYDROCHLORIDELEVOCETIRIZINE DIHYDROCHLORIDEBryant Ranch Prepack1b593c65-2866-45d9-9c94-ac181f4cbc512025-09-15Warnings, Adverse reactionsName fallback
brand name: LEVOCETIRIZINE DIHYDROCHLORIDE
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
Levocetirizine DihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.344ba2d6-4e17-4cef-bd7b-248fbb1af3b62025-09-15Warnings, Adverse reactionsName fallback
brand name: Levocetirizine Dihydrochloride
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
LEVOCETIRIZINE DIHYDROCHLORIDELEVOCETIRIZINE DIHYDROCHLORIDEMacleods Pharmaceuticals Limited8a3c06a5-4a9a-4205-8ae7-c58efeb73c582025-08-22Warnings, Adverse reactionsName fallback
brand name: LEVOCETIRIZINE DIHYDROCHLORIDE
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
Levocetirizine DihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDETeva Pharmaceuticals USA, Inc.4f43d057-cba8-4366-86ba-4be361e4c71f2025-08-11Warnings, Adverse reactionsName 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