FDA.reportPublic FDA data

Application 213514

Type
ANDA
Sponsor
GLAND PHARMA LTD

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 · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A213514-001OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEEQ 0.7% BASESOLUTION/DROPS / OPHTHALMIC2026-01-06

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A213514-001OLOPATADINE HYDROCHLORIDEEQ 0.7% BASESOLUTION/DROPS / OPHTHALMIC2026-01-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213514-001OLOPATADINE HYDROCHLORIDEEQ 0.7% BASESOLUTION/DROPS / OPHTHALMIC2026-01-06011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213514-001OLOPATADINE HYDROCHLORIDEEQ 0.7% BASESOLUTION/DROPS / OPHTHALMIC2026-01-06a50c72e98297…

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 1 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Olopatadine Hydrochloride Ophthalmic SolutionOLOPATADINE HYDROCHLORIDEDr. Reddy's Laboratories Inc.5295f8a2-4e0d-4b6e-9807-e2f36b1d5d152026-04-15WarningsExact identifier
application applno (ANDA): 213514
application number: ANDA213514
Eye Allergy Itch ReliefOLOPATADINE HYDROCHLORIDECARDINAL HEALTH 110, LLC. DBA LEADER5d79fc06-a25f-debb-f08b-523ff26df9002026-02-24WarningsExact identifier
application applno (ANDA): 213514
application number: ANDA213514
Eye Allergy Itch ReliefOLOPATADINE HYDROCHLORIDETARGET CORPORATIONaa112cbd-35c0-a723-48cc-21137332b2c32026-02-03WarningsExact identifier
application applno (ANDA): 213514
application number: ANDA213514
Olopatadine HClOLOPATADINE HYDROCHLORIDERugby Laboratoriesedb068e2-1835-483e-e59c-bcbe13b66d762026-01-22WarningsExact identifier
application applno (ANDA): 213514
application number: ANDA213514
Olopatadine Hydrochloride Ophthalmic SolutionOLOPATADINE HYDROCHLORIDE OPHTHALMICCVS Pharmacy56d56cb8-b04c-5f48-b0c3-5639a79fd2c52026-01-15WarningsExact identifier
application applno (ANDA): 213514
application number: ANDA213514
Eye Allergy Itch ReliefOLOPATADINE HYDROCHLORIDE OPHTHALMICDr. Reddy's Laboratories Inc.dab50913-940c-bcd5-725a-24c18a9f3ea62026-01-15WarningsExact identifier
application applno (ANDA): 213514
application number: ANDA213514
Eye Allergy Itch ReliefOLOPATADINE HYDROCHLORIDE OPHTHALMICWalgreen Company56a99d87-b88b-d140-2dc7-08af5a9f45fb2026-01-15WarningsExact identifier
application applno (ANDA): 213514
application number: ANDA213514
Allergy Relief Eye DropsOLOPATADINE HYDROCHLORIDE OPHTHALMICCVS Pharmacydad4b9f2-f4f8-fe9a-ae9d-35511864dad02026-01-15WarningsExact identifier
application applno (ANDA): 213514
application number: ANDA213514
Olopatadine Hydrochloride Ophthalmic SolutionOLOPATADINE HYDROCHLORIDE OPHTHALMICGland Pharma Limiteda3475f8c-c780-43c0-b22f-08a0ce5608fd2026-01-07WarningsExact identifier
application applno (ANDA): 213514
application number: ANDA213514

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81276ORIG 2025-02-19