Application 019079
- Type
- NDA
- Sponsor
- EYEVANCE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FLAREX | FLUOROMETHOLONE ACETATE | SUSPENSION/DROPS;OPHTHALMIC | 0.1% | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N019079-001 | FLAREX | FLUOROMETHOLONE ACETATE | 0.1% | SUSPENSION/DROPS / OPHTHALMIC | RLD, RS | 1986-02-11 |
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 | 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 | N019079-001 | FLAREX | 0.1% | SUSPENSION/DROPS / OPHTHALMIC | RLD, RS | 1986-02-11 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N019079-001 | FLAREX | 0.1% | SUSPENSION/DROPS / OPHTHALMIC | RLD, RS | 1986-02-11 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N019079-001 | FLAREX | 0.1% | SUSPENSION/DROPS / OPHTHALMIC | RLD, RS | 1986-02-11 | 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Flarex | FLUOROMETHOLONE ACETATE | Harrow Eye, LLC | f060dec4-09dc-4266-ab4c-a6ed49cd8126 | 2025-03-31 | Warnings, Adverse reactions | 019079 NDA019079 |
| Flarex | FLUOROMETHOLONE ACETATE | Eyevance Pharmaceuticals | 19918ea5-8568-44d6-b8ee-7b2197cee85c | 2025-01-17 | Warnings, Adverse reactions | 019079 NDA019079 71776-100 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0065-0096 | Flarex | fluorometholone acetate | Alcon Laboratories, Inc. | NDA | Current |
| 0065-0096 | Flarex | fluorometholone acetate | Alcon Laboratories, Inc. | NDA | Current |
| 71776-100 | Flarex | fluorometholone acetate | Eyevance Pharmaceuticals | NDA | Current |
| 71776-100 | Flarex | fluorometholone acetate | Eyevance Pharmaceuticals | NDA | Current |
| 71776-100 | Flarex | fluorometholone acetate | Eyevance Pharmaceuticals | NDA | Current |
| 71776-100 | Flarex | fluorometholone acetate | Eyevance Pharmaceuticals | NDA | Current |