Application 218321
- Type
- ANDA
- Sponsor
- RUBICON RESEARCH
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FLUTICASONE PROPIONATE | FLUTICASONE PROPIONATE | SPRAY, METERED;NASAL | 0.05MG/SPRAY | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A218321-001 | FLUTICASONE PROPIONATE | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | AB | 2025-06-05 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A218321-001 | AB |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A218321-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | AB | 2025-06-05 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218321-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | AB | 2025-06-05 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A218321-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | AB | 2025-06-05 | 6a471c1ec25d… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218321-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | AB | 2025-06-05 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A218321-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218321-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A218321-001 | AB | 1 | 6a471c1ec25d… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218321-001 | AB | 1 | 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 |
|---|---|---|---|---|---|---|
| FLUTICASONE PROPIONATE | FLUTICASONE PROPIONATE | Preferred Pharmaceuticals Inc. | 8225d521-f1f7-4d21-9095-9a2e1833d1bf | 2026-06-08 | Warnings, Adverse reactions | 218321 ANDA218321 |
| FLUTICASONE PROPIONATE | FLUTICASONE PROPIONATE | Advagen Pharma Ltd | 2c1c465c-d008-470e-aa48-8b44bd60751c | 2026-02-04 | Warnings, Adverse reactions | 218321 ANDA218321 |
| FLUTICASONE PROPIONATE | FLUTICASONE PROPIONATE | NuCare Pharmaceuticals, Inc. | 4849c4e5-58ea-972c-e063-6394a90a809c | 2026-01-13 | Warnings, Adverse reactions | 218321 ANDA218321 |