FDA.reportPublic FDA data

Application 203152

Type
ANDA
Sponsor
USV

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 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
A203152-001OLOPATADINE 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.

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 UTC2022-10A203152-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-07f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A203152-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-07e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A203152-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-07cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A203152-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-07a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A203152-001AT174a2ff9319b5…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203152-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A203152-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A203152-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A203152-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A203152-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A203152-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A203152-001AT1ea99ee380514…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Olopatadine HclOLOPATADINE HCLSola Pharmaceuticalse314e745-1e83-a530-e053-2995a90a67b42025-12-08WarningsExact identifier
application applno (ANDA): 203152
application number: ANDA203152
ndc (product): 70512-520

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 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51293-838olopatadine hydrochlorideolopatadine hydrochlorideECI Pharmaceuticals, LLCANDACurrent
51293-838olopatadine hydrochlorideolopatadine hydrochlorideECI Pharmaceuticals, LLCANDACurrent
64980-517Olopatadine HydrochlorideOlopatadine Hydrochloride USP, 0.1%Rising Pharmaceuticals, Inc.ANDACurrent
68788-7843Olopatadine HydrochlorideOlopatadine HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
69367-233Olopatadine HydrochlorideOlopatadine HydrochlorideWestminster PharmaceuticalsANDACurrent
69367-233Olopatadine HydrochlorideOlopatadine HydrochlorideWestminster Pharmaceuticals, LLCANDACurrent
70512-520Olopatadine HclOlopatadine HclSola PharmaceuticalsANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
19434ORIG2015-12-11
10170ORIG2015-12-09
10171ORIG2015-10-29