FDA.reportPublic FDA data

Application 209752

Type
ANDA
Sponsor
GLAND 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 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
A209752-001OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-20

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 06:07:402026-07A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-204b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-20bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-20782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-2087673890dc5c…
2021-03-12 10:30 UTC2021-03A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-205aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-208869cabd3fbd…
2020-11-12 02:37 UTC2020-11A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-20c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-206a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-201c564ffb4f44…
2023-12-20 04:57 UTC2023-12A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-20ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-20a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-209b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-20a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-203f0d92c62455…
2023-05-13 08:27 UTC2023-05A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-20053a50430f4f…
2023-01-26 05:58 UTC2023-01A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-203bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-203a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-20f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-20e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-20cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A209752-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2020-05-20a50c72e98297…

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 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Olopatadine Hydrochloride Ophthalmic SolutionOLOPATADINE HYDROCHLORIDE OPHTHALMICGland Pharma Limited9a4c58dc-aee6-441f-8081-608e4fd361932026-04-22WarningsExact identifier
application applno (ANDA): 209752
application number: ANDA209752
ndc (product): 68083-231
Olopatadine HydrochlorideOLOPATADINE HYDROCHLORIDERugby Laboratories95424539-7883-2da3-8a46-3d1a19259e152026-02-17WarningsExact identifier
application applno (ANDA): 209752
application number: ANDA209752
ndc (product): 0536-1307
Eye Allergy Itch ReliefOLOPATADINE HCLCARDINAL HEALTH 110, LLC. DBA LEADER135bb2de-b2c0-6f0c-6204-3acbb48dcfbd2026-02-13WarningsExact identifier
application applno (ANDA): 209752
application number: ANDA209752
ndc (product): 70000-0053
Olopatadine Hydrochloride Ophthalmic Solution Once DailyOLOPATADINE HYDROCHLORIDE OPHTHALMICDOLGENCORP, LLCfa75f236-0170-e7be-ce8c-7dff7c36fac82025-12-12WarningsExact identifier
application applno (ANDA): 209752
application number: ANDA209752
ndc (product): 55910-137
Allergy Relief Eye DropsOLOPATADINE HYDROCHLORIDE OPHTHALMICCVS Pharmacy9a9f38fc-af2c-bc7c-abe4-8ad58d51f2e22025-12-12WarningsExact identifier
application applno (ANDA): 209752
application number: ANDA209752
Olopatadine Hydrochloride Ophthalmic SolutionOLOPATADINE HYDROCHLORIDE OPHTHALMICChain Drug Marketing Association INC56d4b17c-bc5d-0734-32c9-bb10ec77f7b42025-12-12WarningsExact identifier
application applno (ANDA): 209752
application number: ANDA209752
Eye Allergy Itch Relief Once Daily ReliefOLOPATADINE HYDROCHLORIDE OPHTHALMICDr. Reddy's Laboratories Inc.d9a01be0-218b-b2b9-1cbf-14a9c160ceb22025-12-12WarningsExact identifier
application applno (ANDA): 209752
application number: ANDA209752
ndc (product): 43598-827
Once Daily ReliefOLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTIONH E B0cb0bb66-def2-35d4-7fe0-987757095d082025-12-12WarningsExact identifier
application applno (ANDA): 209752
application number: ANDA209752
ndc (product): 37808-045
Olopatadine Hydrochloride Ophthalmic SolutionOLOPATADINE HYDROCHLORIDE OPHTHALMICTarget Corporationb233bf3d-e6e6-a724-efd9-389b8e36d2f92025-12-12WarningsExact identifier
application applno (ANDA): 209752
application number: ANDA209752
ndc (product): 11673-688
Olopatadine Hydrochloride Ophthalmic SolutionOLOPATADINE HYDROCHLORIDE OPHTHALMICRite Aid Corporatione3153a5a-35ca-6c10-eec0-8347c2da121f2025-12-12WarningsExact identifier
application applno (ANDA): 209752
application number: ANDA209752
ndc (product): 11822-9975
Olopatadine Hydrochloride Ophthalmic SolutionOLOPATADINE HYDROCHLORIDE OPHTHALMICAlbertsons Companies685192af-d729-3066-5825-6d0e03ce787e2025-12-12WarningsExact identifier
application applno (ANDA): 209752
application number: ANDA209752
ndc (product): 21130-105
Olopatadine Hydrochloride Ophthalmic SolutionOLOPATADINE HYDROCHLORIDE OPHTHALMICWalgreens Companyfb2f06ee-4d50-5e4e-80c9-d2d9fbf4e6a72025-12-12WarningsExact identifier
application applno (ANDA): 209752
application number: ANDA209752
ndc (product): 0363-7131
Olopatadine Hydrochloride Ophthalmic SolutionOLOPATADINE HYDROCHLORIDE OPHTHALMICDr. Reddy's Laboratories Inc.f249d79e-0f62-d2f1-bcbc-22dda253aad22025-12-12WarningsExact identifier
application applno (ANDA): 209752
application number: ANDA209752
ndc (product): 43598-764
CVS Eye Allergy Itch Relief Once DailyOLOPATADINE HYDROCHLORIDE OPHTHALMICCVS Health Corpfd0e681a-f217-1a97-e9a7-d740816234ff2025-12-12WarningsExact identifier
application applno (ANDA): 209752
application number: ANDA209752
ndc (product): 69842-269
Olopatadine Hydrochloride Ophthalmic SolutionOLOPATADINE HYDROCHLORIDE OPHTHALMICChain Drug Marketing Association INCf6d70b01-941b-b796-ceee-7f24b6038e7d2025-12-12WarningsExact identifier
application applno (ANDA): 209752
application number: ANDA209752
ndc (product): 63868-821
Eye Allergy Itch Relief Once Daily ReliefOLOPATADINE HYDROCHLORIDE OPHTHALMICStrategic Sourcing Services LLCad35e069-72ba-b8df-d6bd-18c0345c80ac2025-12-12WarningsExact identifier
application applno (ANDA): 209752
application number: ANDA209752

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 26 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-7131Olopatadine Hydrochloride Ophthalmic SolutionOlopatadine Hydrochloride OphthalmicWalgreens CompanyANDACurrent
0363-7131Olopatadine Hydrochloride Ophthalmic SolutionOlopatadine Hydrochloride OphthalmicWalgreens CompanyANDACurrent
0536-1307Olopatadine Hydrochloride Ophthalmic SolutionOlopatadine Hydrochloride OphthalmicRugby LaboratoriesANDACurrent
0536-1307Olopatadine Hydrochloride Ophthalmic SolutionOlopatadine Hydrochloride OphthalmicRugby LaboratoriesANDACurrent
11673-688Olopatadine Hydrochloride Ophthalmic SolutionOlopatadine Hydrochloride OphthalmicTarget CorporationANDACurrent
11673-688Olopatadine Hydrochloride Ophthalmic SolutionOlopatadine Hydrochloride OphthalmicTarget CorporationANDACurrent
11822-9975Olopatadine Hydrochloride Ophthalmic SolutionOlopatadine Hydrochloride OphthalmicRite Aid CorporationANDACurrent
11822-9975Olopatadine Hydrochloride Ophthalmic SolutionOlopatadine Hydrochloride OphthalmicRite Aid CorporationANDACurrent
21130-105Olopatadine Hydrochloride Ophthalmic SolutionOlopatadine Hydrochloride OphthalmicAlbertsons CompaniesANDACurrent
37808-045Once Daily ReliefOlopatadine Hydrochloride Ophthalmic SolutionH E BANDACurrent
43598-764Olopatadine Hydrochloride Ophthalmic SolutionOlopatadine Hydrochloride OphthalmicDr. Reddy's Laboratories Inc.ANDACurrent
43598-764Olopatadine Hydrochloride Ophthalmic SolutionOlopatadine Hydrochloride OphthalmicDr. Reddy's Laboratories Inc.ANDACurrent
43598-827Eye Allergy Itch ReliefOlopatadine Hydrochloride OphthalmicDr. Reddy's Laboratories Inc.ANDACurrent
43598-827Eye Allergy Itch ReliefOlopatadine Hydrochloride OphthalmicDr. Reddy's Laboratories Inc.ANDACurrent
55910-137Olopatadine Hydrochloride Ophthalmic SolutionOlopatadine Hydrochloride OphthalmicDOLGENCORP, LLCANDACurrent
62011-0468Eye Allergy Itch ReliefOlopatadine Hydrochloride OphthalmicStrategic Sourcing Specialists, LLCANDACurrent
62011-0468Eye Allergy Itch ReliefOlopatadine Hydrochloride OphthalmicStrategic Sourcing Specialists, LLCANDACurrent
63868-821Olopatadine Hydrochloride Ophthalmic SolutionOlopatadine Hydrochloride OphthalmicChain Drug Marketing Association INCANDACurrent
68083-231Olopatadine Hydrochloride Ophthalmic SolutionOlopatadine Hydrochloride OphthalmicGland Pharma LimitedANDACurrent
69842-269CVS Eye Allergy Itch ReliefOlopatadine Hydrochloride OphthalmicCVS Health CorpANDACurrent
69842-269CVS Eye Allergy Itch ReliefOlopatadine Hydrochloride OphthalmicCVS Health CorpANDACurrent
70000-0053Eye Allergy Itch ReliefOlopatadine Hydrochloride OphthalmicCardinal HealthANDACurrent
70000-0053Eye Allergy Itch ReliefOlopatadine Hydrochloride OphthalmicCardinal HealthANDACurrent
70000-0053Eye Allergy Itch ReliefOlopatadine Hydrochloride OphthalmicCardinal HealthANDACurrent
70677-0122Olopatadine Hydrochloride Ophthalmic SolutionOlopatadine Hydrochloride OphthalmicStrategic Sourcing Specialists, LLCANDACurrent
70677-0122Olopatadine Hydrochloride Ophthalmic SolutionOlopatadine Hydrochloride OphthalmicStrategic Sourcing Specialists, LLCANDACurrent