FDA.reportPublic FDA data

Application 204706

Type
ANDA
Sponsor
ZAMBON SPA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDESOLUTION/DROPS;OPHTHALMICEQ 0.1% 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
A204706-001OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-07

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 22:54:322026-06A204706-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-07a50c72e98297…

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 4 · 72 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDE OPHTHALMICGolden State Medical Supply, Inc.50b02d58-dd82-6d0a-e063-6294a90a28fd2026-04-30WarningsName fallback
brand name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDESportpharm LLCf0cc699c-545d-4097-b85d-b67ba550863c2026-04-24WarningsName fallback
brand name: OLOPATADINE HYDROCHLORIDE
generic name: OLOPATADINE HYDROCHLORIDE
Retaine AllergyOLOPATADINE HYDROCHLORIDEOCuSOFT LLCe0a01606-275d-448c-8838-ca46f1e612e52026-04-23WarningsName fallback
generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEBest Choice04c7b08c-52c1-427c-8b8f-fe67444fbca42026-04-22WarningsName fallback
brand name: OLOPATADINE HYDROCHLORIDE
generic name: OLOPATADINE HYDROCHLORIDE
Olopatadine Hydrochloride Ophthalmic SolutionOLOPATADINE HYDROCHLORIDEDr. Reddy's Laboratories Inc.5295f8a2-4e0d-4b6e-9807-e2f36b1d5d152026-04-15WarningsName fallback
generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEBluePoint Laboratories3e86783f-0001-625f-e063-6294a90acd202026-03-25WarningsName fallback
brand name: OLOPATADINE HYDROCHLORIDE
generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDESomerset Therapeutics, LLC6ee9f8f5-973c-4c71-8069-e76cd87b07dc2026-03-25WarningsName fallback
brand name: OLOPATADINE HYDROCHLORIDE
generic name: OLOPATADINE HYDROCHLORIDE
Olopatadine HydrochlorideOLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTIONRUGBY LABORATORIES96ad3623-f7cc-4c1c-aa65-d89077873b692026-02-24WarningsName fallback
brand name: Olopatadine Hydrochloride
Eye Allergy Itch ReliefOLOPATADINE HYDROCHLORIDECARDINAL HEALTH 110, LLC. DBA LEADER5d79fc06-a25f-debb-f08b-523ff26df9002026-02-24WarningsName fallback
generic name: OLOPATADINE HYDROCHLORIDE
Olopatadine HydrochlorideOLOPATADINE HYDROCHLORIDERugby Laboratories95424539-7883-2da3-8a46-3d1a19259e152026-02-17WarningsName fallback
brand name: Olopatadine Hydrochloride
generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEAmerisourceBergen Drug Corp18f851e3-24c6-44fd-8376-0f5418ded9a92026-02-16WarningsName fallback
brand name: OLOPATADINE HYDROCHLORIDE
generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDE OPHTHALMICAmerisourceBergen Drug Corpea97d3d8-dc96-4c40-91e7-f076c588bf122026-02-16WarningsName fallback
brand name: OLOPATADINE HYDROCHLORIDE
Eye Allergy Itch and Redness ReliefOLOPATADINE HYDROCHLORIDECARDINAL HEALTH 110, LLC. DBA LEADER5255d142-7d04-ab80-fa97-b11c4486e42c2026-02-13WarningsName fallback
generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEYYBA Corp47f8ae9b-d92b-4bcb-e063-6294a90af45a2026-02-03WarningsName fallback
brand name: OLOPATADINE HYDROCHLORIDE
generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEGLENMARK THERAPEUTICS INC., USA07e8b359-d4ae-4b5b-81dc-c7e57e172c582026-01-27WarningsName fallback
brand name: OLOPATADINE HYDROCHLORIDE
generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDE OPHTHALMICGLENMARK THERAPEUTICS INC., USAa80c3fd2-47b7-4ed0-b862-9c50996846072026-01-27WarningsName fallback
brand name: OLOPATADINE HYDROCHLORIDE
Olopatadine HClOLOPATADINE HYDROCHLORIDERugby Laboratoriesedb068e2-1835-483e-e59c-bcbe13b66d762026-01-22WarningsName fallback
generic name: OLOPATADINE HYDROCHLORIDE
PATADAY ONCE DAILY RELIEFOLOPATADINE HYDROCHLORIDEAlcon Laboratories, Inc.1c7d2342-ba1c-4244-9814-d92a05725d4e2026-01-20WarningsName fallback
generic name: OLOPATADINE HYDROCHLORIDE
PATADAY TWICE A DAY RELIEFOLOPATADINE HYDROCHLORIDEAlcon Laboratories, Inc.b7a24375-25df-4405-aa7c-34c46af511942026-01-20WarningsName fallback
generic name: OLOPATADINE HYDROCHLORIDE
PATADAY ONCE DAILY RELIEFOLOPATADINE HYDROCHLORIDEAlcon Laboratories, Inc.6d07a5d6-265c-4735-97b3-8a2575b276cb2026-01-20WarningsName fallback
generic name: OLOPATADINE HYDROCHLORIDE

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
68788-6317Olopatadine HydrochlorideOlopatadine Hydrochloride 0.1%Preferred Pharmaceuticals Inc.ANDACurrent
68788-7403Olopatadine HydrochlorideOlopatadine Hydrochloride 0.1%Preferred Pharmaceuticals Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
10381ORIG2015-12-09