Application 020409
- Type
- NDA
- Sponsor
- TEVA BRANDED PHARM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NASAREL | FLUNISOLIDE | SPRAY, METERED;NASAL | 0.029MG/SPRAY | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020409-001 | NASAREL | FLUNISOLIDE | 0.029MG/SPRAY | SPRAY, METERED / NASAL | 1995-03-08 |
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 | N020409-001 | NASAREL | 0.029MG/SPRAY | SPRAY, METERED / NASAL | 1995-03-08 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N020409-001 | NASAREL | 0.029MG/SPRAY | SPRAY, METERED / NASAL | 1995-03-08 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N020409-001 | NASAREL | 0.029MG/SPRAY | SPRAY, METERED / NASAL | 1995-03-08 | 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 |
|---|---|---|---|---|---|---|
| Flunisolide | FLUNISOLIDE | Oceanside Pharmaceuticals | 50d87523-e1fb-4342-825f-9dba972c6a25 | 2025-05-02 | Warnings, Adverse reactions | FLUNISOLIDE |
| Flunisolide | FLUNISOLIDE | Ingenus Pharmaceuticals, LLC | f39cae46-c68f-47ef-82f3-4fd3dd46c74c | 2025-04-30 | Warnings, Adverse reactions | FLUNISOLIDE |
| Flunisolide | FLUNISOLIDE | Bausch & Lomb Incorporated | 7c72c954-3758-40c3-9977-d03b25d71e0a | 2025-01-16 | Warnings, Adverse reactions | FLUNISOLIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.