FDA.reportPublic FDA data

Application 209015

Type
ANDA
Sponsor
APOTEX INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDESOLUTION/DROPS;OPHTHALMICEQ 0.7% BASENoNo

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 4 of 4 · 70 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDERetail Business Services, LLC.bca27f6a-d1b1-1d6a-e053-2995a90a37b52021-04-01WarningsName fallback
brand name: OLOPATADINE HYDROCHLORIDE
generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEAllwell Health Inc12d48ef6-ccf1-4bc3-8469-0061bb083f7c2021-03-01WarningsName fallback
brand name: OLOPATADINE HYDROCHLORIDE
generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEKroger Companydc80e8b0-21f7-4b12-93cb-738619f2be7c2021-01-28WarningsName fallback
brand name: OLOPATADINE HYDROCHLORIDE
generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEKroger Companyf8993bc2-0fb3-4802-8187-3677d0e580262021-01-28WarningsName fallback
brand name: OLOPATADINE HYDROCHLORIDE
generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEAurohealth LLC5f9e93e7-ff12-484d-add8-4f834193c1c62020-10-09WarningsName fallback
brand name: OLOPATADINE HYDROCHLORIDE
generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEAurohealth LLCc12af544-995a-43d7-8404-94906d52fa072020-08-28WarningsName fallback
brand name: OLOPATADINE HYDROCHLORIDE
generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEAurohealth LLCaa763fdb-22a8-4975-b634-d4e6e105f5882020-08-28WarningsName fallback
brand name: OLOPATADINE HYDROCHLORIDE
generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEAurohealth LLC8fb16daa-340d-45a0-ab22-e028d77e24762020-08-21WarningsName fallback
brand name: OLOPATADINE HYDROCHLORIDE
generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEAlembic Pharmaceuticals Inc.dbcdf10c-5adb-4d48-97ce-f4b82c6bc77d2019-05-07Warnings, Adverse reactionsName fallback
brand name: OLOPATADINE HYDROCHLORIDE
generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEAlembic Pharmaceuticals Inc.7b36e554-d68a-47e0-bf3c-f4cfdc3746b62019-02-21Warnings, Adverse reactionsName fallback
brand name: OLOPATADINE HYDROCHLORIDE
generic name: OLOPATADINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
58351ORIG2019-04-18