Home Applications 020191 Application 020191
Type NDA
Sponsor NOVARTIS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ALOMIDE LODOXAMIDE TROMETHAMINE SOLUTION/DROPS;OPHTHALMIC EQ 0.1% BASE 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 N020191-001 ALOMIDE LODOXAMIDE TROMETHAMINE EQ 0.1% BASE SOLUTION/DROPS / OPHTHALMIC RLD 1993-09-23
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 N020191-001 ALOMIDE EQ 0.1% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 1993-09-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020191-001 ALOMIDE EQ 0.1% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 1993-09-23 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N020191-001 ALOMIDE EQ 0.1% BASE SOLUTION/DROPS / OPHTHALMIC RLD 1993-09-23 a50c72e98297…
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 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0065-0345 ALOMIDE lodoxamide tromethamine Alcon Laboratories, Inc. NDA Current 0065-0345 ALOMIDE lodoxamide tromethamine Alcon Laboratories, Inc. NDA Current 0065-0345 ALOMIDE lodoxamide tromethamine Alcon Laboratories, Inc. NDA Current 0065-0345 ALOMIDE lodoxamide tromethamine Alcon Laboratories, Inc. NDA Current 0065-0345 ALOMIDE lodoxamide tromethamine Alcon Laboratories, Inc. NDA Current 0078-0736 ALOMIDE lodoxamide tromethamine Novartis Pharmaceuticals Corporation NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 34357 SUPPL 2003-07-08 24557 SUPPL 2003-07-06