FDA.reportPublic FDA data

Application 075446

Type
ANDA
Sponsor
APOTEX INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BETAXOLOL HYDROCHLORIDEBETAXOLOL HYDROCHLORIDESOLUTION/DROPS;OPHTHALMICEQ 0.5% 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
A075446-001BETAXOLOL HYDROCHLORIDEBETAXOLOL HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMIC2000-09-28

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 UTC2022-10A075446-001BETAXOLOL HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMIC2000-09-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075446-001BETAXOLOL HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMIC2000-09-28e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075446-001BETAXOLOL HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMIC2000-09-28cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A075446-001BETAXOLOL HYDROCHLORIDEEQ 0.5% BASESOLUTION/DROPS / OPHTHALMIC2000-09-28a50c72e98297…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Betoptic SBETAXOLOL HYDROCHLORIDENovartis Pharmaceuticals Corporation905ba189-456c-4aa4-8231-39a971374ad82025-01-22Warnings, Adverse reactionsName fallback
generic name: BETAXOLOL HYDROCHLORIDE
BETAXOLOL HYDROCHLORIDEBETAXOLOL HYDROCHLORIDEKVK-TECH, INC.f3b50bbb-df03-4ed7-9d8d-180edc2abd542024-04-30Warnings, Adverse reactionsName fallback
brand name: BETAXOLOL HYDROCHLORIDE
generic name: BETAXOLOL HYDROCHLORIDE
Betaxolol HydrochlorideBETAXOLOL HYDROCHLORIDESandoz Inca73519d5-546c-4377-92ed-0d4be2685d602023-10-31Warnings, Adverse reactionsName fallback
brand name: Betaxolol Hydrochloride
generic name: BETAXOLOL HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
30886ORIG2000-09-28