Home Applications 021114 Application 021114
Type NDA
Sponsor ALCON PHARMS LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 BETAXON LEVOBETAXOLOL HYDROCHLORIDE SUSPENSION/DROPS;OPHTHALMIC EQ 0.5% BASE No No
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021114-001 BETAXON LEVOBETAXOLOL HYDROCHLORIDE EQ 0.5% BASE SUSPENSION/DROPS / OPHTHALMIC 2000-02-23
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2022-10-28 04:53 UTC 2022-10 N021114-001 BETAXON EQ 0.5% BASE SUSPENSION/DROPS / OPHTHALMIC 2000-02-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021114-001 BETAXON EQ 0.5% BASE SUSPENSION/DROPS / OPHTHALMIC 2000-02-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021114-001 BETAXON EQ 0.5% BASE SUSPENSION/DROPS / OPHTHALMIC 2000-02-23 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N021114-001 BETAXON EQ 0.5% BASE SUSPENSION/DROPS / OPHTHALMIC 2000-02-23 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents# Document, Submission type, Date table Document Submission type Date 26807 SUPPL 2010-03-18 14421 SUPPL 2010-03-09 26806 SUPPL 2006-10-02 41958 ORIG 2005-06-10 4371 ORIG 2004-10-26 14420 ORIG 2000-02-29 52002 SUPPL 1900-01-01 52001 SUPPL 1900-01-01