Home Applications 019779 Application 019779
Type NDA
Sponsor NOVARTIS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 IOPIDINE APRACLONIDINE HYDROCHLORIDE SOLUTION/DROPS;OPHTHALMIC EQ 1% BASE Yes Yes
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 N019779-001 IOPIDINE APRACLONIDINE HYDROCHLORIDE EQ 1% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 1987-12-31
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 N019779-001 IOPIDINE EQ 1% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 1987-12-31 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N019779-001 IOPIDINE EQ 1% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 1987-12-31 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N019779-001 IOPIDINE EQ 1% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 1987-12-31 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N019779-001 IOPIDINE EQ 1% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 1987-12-31 a50c72e98297…
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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join IOPIDINE 1% APRACLONIDINE HYDROCHLORIDE OPHTHALMIC SOLUTION Harrow Eye, LLC 00f18845-ccde-8678-e063-6294a90a3374 2026-05-08 Warnings, Adverse reactions Exact identifier application applno (NDA): 019779 application number: NDA019779
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 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0065-0660 IOPIDINE apraclonidine hydrochloride Alcon Laboratories, Inc. NDA Current 0065-0660 IOPIDINE apraclonidine hydrochloride Alcon Laboratories, Inc. NDA Current 0065-0660 IOPIDINE apraclonidine hydrochloride Alcon Laboratories, Inc. NDA Current 0065-0660 IOPIDINE apraclonidine hydrochloride Alcon Laboratories, Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 85531 SUPPL 2026-03-26 85419 SUPPL 2026-03-20 52811 SUPPL 2018-03-05 52792 SUPPL 2018-03-02 47974 SUPPL 2017-04-12 47891 SUPPL 2017-04-07 33949 SUPPL 2004-12-30 19213 SUPPL 2004-12-30 11713 SUPPL 2004-12-30 1613 SUPPL 2004-12-30 1612 SUPPL 2003-06-08 19212 SUPPL 2002-03-22 11712 SUPPL 2002-03-22