FDA.reportPublic FDA data

Application 209995

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDESOLUTION/DROPS;OPHTHALMICEQ 0.2% BASENoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A209995-001OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2019-04-04

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
2026-08-01 22:54:322026-06A209995-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2019-04-04a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEBest Choice04c7b08c-52c1-427c-8b8f-fe67444fbca42026-04-22WarningsExact identifier
application applno (ANDA): 209995
application number: ANDA209995
OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEA-S Medication Solutions7c89196a-cf74-4ce3-a9fd-b3d42a9e2a192025-11-18WarningsExact identifier
application applno (ANDA): 209995
application number: ANDA209995
ndc (product): 50090-5613
OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEAurohealth LLCb022f8f9-ad3d-4a6d-96aa-24c1ccd1f4222025-10-09WarningsExact identifier
application applno (ANDA): 209995
application number: ANDA209995
ndc (product): 58602-007
OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDERITE AID CORPORATION1ce2f408-6eff-ca83-e063-6394a90a6d1a2024-10-22WarningsExact identifier
application applno (ANDA): 209995
application number: ANDA209995
OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDETOPCO ASSOCIATES LLC1932ee68-43a5-6474-e063-6294a90aacaf2024-06-14WarningsExact identifier
application applno (ANDA): 209995
application number: ANDA209995
OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEAmerisource Bergen067baa0b-5c01-4908-92de-ad79c73d2c372023-07-10WarningsExact identifier
application applno (ANDA): 209995
application number: ANDA209995
ndc (product): 46122-671
OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEMeijerd15e4288-c315-48dc-b120-6836a4b4b8c62022-08-11WarningsExact identifier
application applno (ANDA): 209995
application number: ANDA209995
ndc (product): 79481-1001
OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEBluePoint Laboratoriesdbd28ee2-bbb5-a4b1-e053-2a95a90afff42022-04-08WarningsExact identifier
application applno (ANDA): 209995
application number: ANDA209995
ndc (product): 68001-530
OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEWALGREEN CO.da0f9110-8362-497c-a209-c33a8fa8d9952021-11-11WarningsExact identifier
application applno (ANDA): 209995
application number: ANDA209995
ndc (product): 0363-8022
OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEHarris Teeterb680db29-d05b-62c3-e053-2995a90a29212021-10-01WarningsExact identifier
application applno (ANDA): 209995
application number: ANDA209995
ndc (product): 72036-009
OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEWal-Mart Stores, Inc.34723580-dfd0-4ab7-a757-d86570261e7f2021-09-20WarningsExact identifier
application applno (ANDA): 209995
application number: ANDA209995
ndc (product): 79903-001
OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDERetail Business Services, LLC.bca27f6a-d1b1-1d6a-e053-2995a90a37b52021-04-01WarningsExact identifier
application applno (ANDA): 209995
application number: ANDA209995
ndc (product): 72476-851
OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEAllwell Health Inc12d48ef6-ccf1-4bc3-8469-0061bb083f7c2021-03-01WarningsExact identifier
application applno (ANDA): 209995
application number: ANDA209995
ndc (product): 80539-001
OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEKroger Companydc80e8b0-21f7-4b12-93cb-738619f2be7c2021-01-28WarningsExact identifier
application applno (ANDA): 209995
application number: ANDA209995
ndc (product): 30142-026
OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEAurohealth LLC5f9e93e7-ff12-484d-add8-4f834193c1c62020-10-09WarningsExact identifier
application applno (ANDA): 209995
application number: ANDA209995
ndc (product): 58602-013
OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEAurohealth LLCaa763fdb-22a8-4975-b634-d4e6e105f5882020-08-28WarningsExact identifier
application applno (ANDA): 209995
application number: ANDA209995
ndc (product): 58602-010

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 38 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-8022OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEWALGREEN CO.ANDACurrent
0363-8022OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEWALGREEN CO.ANDACurrent
0363-8022OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEWALGREEN CO.ANDACurrent
0363-8022OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEWALGREEN CO.ANDACurrent
0363-8022OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEWALGREEN CO.ANDACurrent
30142-026OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEKroger CompanyANDACurrent
30142-026OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEKroger CompanyANDACurrent
30142-026OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEKroger CompanyANDACurrent
46122-671OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEAmerisource BergenANDACurrent
46122-671OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEAmerisource BergenANDACurrent
46122-671OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEAmerisource BergenANDACurrent
46122-671OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEAmerisource BergenANDACurrent
50090-5613OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEA-S Medication SolutionsANDACurrent
50090-5613OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEA-S Medication SolutionsANDACurrent
58602-007OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEAurohealth LLCANDACurrent
58602-007OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEAurohealth LLCANDACurrent
58602-007OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEAurohealth LLCANDACurrent
58602-007OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEAurohealth LLCANDACurrent
58602-007OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEAurohealth LLCANDACurrent
58602-010OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEAurohealth LLCANDACurrent
58602-010OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEAurohealth LLCANDACurrent
58602-013OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEAurohealth LLCANDACurrent
58602-013OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEAurohealth LLCANDACurrent
58602-013OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEAurohealth LLCANDACurrent
59651-066Olopatadine HydrochlorideOlopatadine HydrochlorideAurobindo Pharma LimitedANDACurrent
59651-066Olopatadine HydrochlorideOlopatadine HydrochlorideAurobindo Pharma LimitedANDACurrent
68001-530OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEBluePoint LaboratoriesANDACurrent
72036-009OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEHarris TeeterANDACurrent
72036-009OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEHarris TeeterANDACurrent
72476-851OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDERetail Business Services, LLC.ANDACurrent
79481-1001OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEMeijerANDACurrent
79481-1001OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEMeijerANDACurrent
79481-1001OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEMeijerANDACurrent
79481-1001OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEMeijerANDACurrent
79903-001OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEWal-Mart Stores, Inc.ANDACurrent
79903-001OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEWal-Mart Inc.ANDACurrent
79903-001OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEWal-Mart Inc.ANDACurrent
80539-001OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEAllwell Health IncANDACurrent