Home Applications 205388 Application 205388
Type NDA
Sponsor OMEROS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 OMIDRIA KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE SOLUTION;IRRIGATION EQ 0.3% BASE;EQ 1% BASE Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N205388-001 OMIDRIA KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N205388-001 AT
Orange Book patents# Current patent rows page 1 of 1 · 5 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N205388-001 9066856 2033-10-23 Drug product 2015-07-13 N205388-001 9486406 2033-10-23 Drug product 2016-11-09 N205388-001 9855246 2033-10-23 Drug product 2018-01-05 N205388-001 9066856*PED 2034-04-23 Pediatric extension N205388-001 9486406*PED 2034-04-23 Pediatric extension
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.
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 2026-08-01 22:54:32 2026-06 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 N205388-001 AT 1 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-01 22:54:32 2026-06 N205388-001 9066856 2033-10-23 Drug product 2015-07-13 a50c72e98297…2026-08-01 22:54:32 2026-06 N205388-001 9486406 2033-10-23 Drug product 2016-11-09 a50c72e98297…2026-08-01 22:54:32 2026-06 N205388-001 9855246 2033-10-23 Drug product 2018-01-05 a50c72e98297…2026-08-01 22:54:32 2026-06 N205388-001 9066856*PED 2034-04-23 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N205388-001 9486406*PED 2034-04-23 Pediatric extension a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
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 62225-600 Omidria phenylephrine and ketorolac Omeros Corporation NDA Current 62225-600 Omidria phenylephrine and ketorolac Omeros Corporation NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 50778 SUPPL 2017-12-20 50654 SUPPL 2017-12-11 19641 SUPPL 2016-06-24 24493 ORIG 2014-12-09 22986 ORIG 2014-12-09 32666 ORIG 2014-06-03 19640 ORIG 2014-06-03 51555 SUPPL 1900-01-01 51554 SUPPL 1900-01-01 51553 SUPPL 1900-01-01