Home Applications 021565 Application 021565
Type NDA
Sponsor ALLERGAN Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ELESTAT EPINASTINE HYDROCHLORIDE SOLUTION/DROPS;OPHTHALMIC 0.05% 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 N021565-001 ELESTAT EPINASTINE HYDROCHLORIDE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION/DROPS / OPHTHALMIC RLD 2003-10-16
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 N021565-001 ELESTAT 0.05% SOLUTION/DROPS / OPHTHALMIC RLD 2003-10-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021565-001 ELESTAT 0.05% SOLUTION/DROPS / OPHTHALMIC RLD 2003-10-16 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021565-001 ELESTAT 0.05% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2003-10-16 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N021565-001 ELESTAT 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION/DROPS / OPHTHALMIC RLD 2003-10-16 a50c72e98297…
Observed Orange Book normalized TE history# 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 · 2 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0023-9201 ELESTAT epinastine hydrochloride Allergan, Inc. NDA Current 0023-9201 ELESTAT epinastine hydrochloride Allergan, Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 15781 SUPPL 2011-12-23 28120 SUPPL 2011-12-22 28119 SUPPL 2005-08-19 37228 SUPPL 2005-08-16 42211 ORIG 2003-12-31 15780 ORIG 2003-10-17 5740 ORIG 2003-10-14