Home Applications 021980 Application 021980
Type NDA
Sponsor ALCON LABS INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 FLUORESCITE FLUORESCEIN SODIUM INJECTABLE;INTRAVENOUS EQ 500MG BASE/5ML (EQ 100MG BASE/ML) Yes Yes
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 N021980-001 FLUORESCITE FLUORESCEIN SODIUM EQ 500MG BASE/5ML (EQ 100MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-03-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021980-001 AP
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 N021980-001 FLUORESCITE EQ 500MG BASE/5ML (EQ 100MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-03-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021980-001 FLUORESCITE EQ 500MG BASE/5ML (EQ 100MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-03-28 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N021980-001 FLUORESCITE EQ 500MG BASE/5ML (EQ 100MG BASE/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2006-03-28 a50c72e98297…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
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.
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 · 5 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0065-0092 FLUORESCITE fluorescein sodium Alcon Laboratories, Inc. NDA Current 0065-0092 FLUORESCITE fluorescein sodium Alcon, Inc. NDA Current 0065-0092 FLUORESCITE fluorescein sodium Alcon, Inc. NDA Current 0065-0092 FLUORESCITE fluorescein sodium Alcon, Inc. NDA Current 0065-0092 FLUORESCITE fluorescein sodium Alcon, Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 69353 SUPPL 2021-11-18 37989 SUPPL 2016-02-11 6582 SUPPL 2016-02-04 42367 ORIG 2008-02-22 16687 ORIG 2007-01-23 28971 ORIG 2006-04-05