Home Applications 050628 Application 050628
Type NDA
Sponsor EYEVANCE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TOBRASONE FLUOROMETHOLONE ACETATE; TOBRAMYCIN SUSPENSION/DROPS;OPHTHALMIC 0.1%;0.3% No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 N050628-001 TOBRASONE FLUOROMETHOLONE ACETATE; TOBRAMYCIN 0.1%;0.3% SUSPENSION/DROPS / OPHTHALMIC 1989-07-21
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 · 43 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 2022-09-29 23:25 UTC 2022-09 N050628-001 TOBRASONE 0.1%;0.3% SUSPENSION/DROPS / OPHTHALMIC 1989-07-21 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N050628-001 TOBRASONE 0.1%;0.3% SUSPENSION/DROPS / OPHTHALMIC 1989-07-21 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N050628-001 TOBRASONE 0.1%;0.3% SUSPENSION/DROPS / OPHTHALMIC 1989-07-21 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 39052 SUPPL 2003-04-23