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 3 of 4 · 75 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Levocetirizine DihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEMicro Labs Limited717eb542-3a05-485e-be76-3930efb40d332025-08-01Warnings, Adverse reactionsName fallback
brand name: Levocetirizine Dihydrochloride
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEPadagis Israel Pharmaceuticals Ltd2965ef46-18db-4615-9dce-bfb0f0b3366a2025-07-31Warnings, Adverse reactionsName fallback
brand name: levocetirizine dihydrochloride
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
XyzalLEVOCETIRIZINE DIHYDROCHLORIDEChattem, Inc.1673f7ff-0c7c-4403-86cf-c05eb14752222025-07-22Warnings, Adverse reactionsName fallback
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
allergy reliefLEVOCETIRIZINE DIHYDROCHLORIDEWalgreen Company5033f8e3-c1c4-44e9-a774-703d9b04e82c2025-07-16WarningsName fallback
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEPreferred Pharmaceuticals, Inc.8f308352-5854-409e-8bf7-bc9958cc3c5e2025-07-14Warnings, Adverse reactionsName fallback
brand name: levocetirizine dihydrochloride
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
Levocetirizine DihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEProficient Rx LP9f83891c-2466-4972-b0f4-b92cc7337be32025-07-01Warnings, Adverse reactionsName fallback
brand name: Levocetirizine Dihydrochloride
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
Levocetirizine DihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEBryant Ranch Prepacke885f084-9ce2-4e0c-aadb-c9d651224e5b2025-06-27Warnings, Adverse reactionsName fallback
brand name: Levocetirizine Dihydrochloride
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDECamber Pharmaceuticals, Inc.dc8adb01-a7ca-490b-b476-8915f1a2e6db2025-06-12Warnings, Adverse reactionsName fallback
brand name: levocetirizine dihydrochloride
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
Allergy ReliefLEVOCETIRIZINE DIHYDROCHLORIDEMeijer Distribution Incca6d0ba0-96af-41e9-a3e9-0c7783db30112025-05-20WarningsName fallback
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
LEVOCETIRIZINE DIHYDROCHLORIDELEVOCETIRIZINE DIHYDROCHLORIDENuCare Pharmaceuticals, Inc.348eadb6-5be2-f8c7-e063-6394a90a13142025-05-07Warnings, Adverse reactionsName fallback
brand name: LEVOCETIRIZINE DIHYDROCHLORIDE
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
LEVOCETIRIZINE DIHYDROCHLORIDELEVOCETIRIZINE DIHYDROCHLORIDEProficient Rx LPfe13f6c0-610b-43b6-8693-e9923ba405d52025-03-01Warnings, Adverse reactionsName fallback
brand name: LEVOCETIRIZINE DIHYDROCHLORIDE
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labs51d88b2a-d10d-4e7a-b874-98de480692232025-02-21Warnings, Adverse reactionsName fallback
brand name: levocetirizine dihydrochloride
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
Levocetirizine DihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEMicro Labs Limited78ff8e86-ee5b-4626-aa81-49e974febf1d2025-02-16WarningsName fallback
brand name: Levocetirizine Dihydrochloride
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
Levocetirizine DihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.57c7c673-790c-4158-87ca-7d8fb68c42862025-02-04Warnings, Adverse reactionsName fallback
brand name: Levocetirizine Dihydrochloride
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
LEVOCETIRIZINE DIHYDROCHLORIDELEVOCETIRIZINE DIHYDROCHLORIDEPreferred Pharmaceuticals Inc.5d6941c7-ef0a-48d3-93dc-53bc2c9789de2025-01-20Warnings, Adverse reactionsName fallback
brand name: LEVOCETIRIZINE DIHYDROCHLORIDE
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
Levocetirizine DihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDENuCare Pharmaceuticals, Inc.2787aaa2-5209-f7d5-e063-6294a90a71032024-11-22Warnings, Adverse reactionsName fallback
brand name: Levocetirizine Dihydrochloride
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
Allergy Relief 24HRLEVOCETIRIZINE DIHYDROCHLORIDEVELOCITY PHARMA LLC8ba208dc-34fe-453a-8658-ed4f232e1a942024-10-29WarningsName fallback
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEBryant Ranch Prepack628c26f0-f6bb-4658-ba50-8ca04cd859cb2024-07-10Warnings, Adverse reactionsName fallback
brand name: levocetirizine dihydrochloride
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
Levocetirizine DihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDENuCare Pharmaceuticals,Inc.97a67686-7e94-dd77-e053-2995a90a42c62024-06-19Warnings, Adverse reactionsName fallback
brand name: Levocetirizine Dihydrochloride
generic name: LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEBryant Ranch Prepack4d0a0f8e-b298-46d2-b27d-0bb737507fed2024-04-12Warnings, 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