Application 217088
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
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 |
|---|---|---|---|---|---|---|---|
| A217088-001 | FLUTICASONE PROPIONATE | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | 2024-05-10 |
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 | A217088-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | 2024-05-10 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217088-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | 2024-05-10 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A217088-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | 2024-05-10 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217088-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | 2024-05-10 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217088-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | 2024-05-10 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217088-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | 2024-05-10 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217088-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | 2024-05-10 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A217088-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | 2024-05-10 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A217088-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | 2024-05-10 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A217088-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | 2024-05-10 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A217088-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | 2024-05-10 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A217088-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | 2024-05-10 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A217088-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | 2024-05-10 | 1e350fbaab3a… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217088-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | 2024-05-10 | 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 | Family Dollar Stores, LLC | 4dd65267-9905-4f45-e063-6294a90a2516 | 2026-06-17 | Warnings | 217088 ANDA217088 |
| Mucinex Nasal Congestion and Allergy Relief | FLUTICASONE PROPIONATE | Reckitt Benckiser LLC | 47d8bb65-0bff-f24d-e063-6394a90affaf | 2026-05-20 | Warnings | 217088 ANDA217088 |
| 365 WHOLE FOODS MARKET FLUTICASONE PROPIONATE | FLUTICASONE PROPIONATE | Whole Foods Market, Inc. | 313517bd-cb08-49a5-8ef1-e5522cc21c80 | 2026-01-22 | Warnings | 217088 ANDA217088 |
| CHILDRENS FLUTICASONE PROPIONATE | FLUTICASONE PROPIONATE | Aurohealth LLC | 180ef101-dca6-496f-8376-63449d82d083 | 2025-12-08 | Warnings | 217088 ANDA217088 |
| FLUTICASONE PROPIONATE | FLUTICASONE PROPIONATE | Aurohealth LLC | 044a06a1-74fc-43ff-b136-37ad41220941 | 2025-12-08 | Warnings | 217088 ANDA217088 |
| FLUTICARE | FLUTICASONE PROPIONATE | INNOVUS PHARMACEUTICALS, INC. | fed545ab-6a85-4ce3-8651-370e279db49e | 2025-07-16 | Warnings | 217088 ANDA217088 |