FDA.reportPublic FDA data

Application 206087

Type
ANDA
Sponsor
CIPLA

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 44.

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
A206087-001OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2017-12-05

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.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A206087-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2017-12-05f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A206087-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2017-12-05e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A206087-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2017-12-05cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A206087-001OLOPATADINE HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OPHTHALMIC2017-12-05a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A206087-001AT174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A206087-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A206087-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A206087-001AT1ea99ee380514…

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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEWALGREEN COMPANY26703751-00c4-451b-a5be-242da9cd2b882025-12-16WarningsExact identifier
application applno (ANDA): 206087
application number: ANDA206087
EQUATE OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEWAL-MART STORES, INC.,3ffd2bec-c5d1-47ff-ae5f-bc20e9c1de842025-08-19WarningsExact identifier
application applno (ANDA): 206087
application number: ANDA206087
Olopatadine Hydrochloride Ophthalmic SolutionOLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTIONTARGET CORPORATION355df5ce-95e2-4d05-9114-a3190d934d3a2025-04-14WarningsExact identifier
application applno (ANDA): 206087
application number: ANDA206087
LEADER OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDECARDINAL HEALTH71d922d2-22a5-4103-a3eb-126094ee8ef52025-04-14WarningsExact identifier
application applno (ANDA): 206087
application number: ANDA206087
OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEBausch & Lomb Incorporated9e4c86f3-e674-4727-a136-6735591ef8162025-01-30WarningsExact identifier
application applno (ANDA): 206087
application number: ANDA206087
OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEBausch & Lomb Incorporatedc420fd56-adea-4796-adaa-977b91fbf20a2025-01-30WarningsExact identifier
application applno (ANDA): 206087
application number: ANDA206087

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
69097-276Olopatadine HydrochlorideOlopatadine Hydrochloride Ophthalmic SolutionCipla USA Inc.ANDACurrent
69097-600Olopatadine HydrochlorideOlopatadine HydrochlorideCipla USA Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
48976ORIG2017-07-13