Application 217431
- Type
- ANDA
- Sponsor
- LUPIN LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 002 | IVACAFTOR | IVACAFTOR | GRANULE;ORAL | 25MG | No | No |
| 003 | IVACAFTOR | IVACAFTOR | GRANULE;ORAL | 50MG | No | No |
| 004 | IVACAFTOR | IVACAFTOR | GRANULE;ORAL | 75MG | No | No |
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 |
|---|---|---|---|---|---|---|
| Kalydeco | IVACAFTOR | Vertex Pharmaceuticals Incorporated | 0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe25 | 2026-03-23 | Warnings, Adverse reactions | IVACAFTOR |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 81314 | ORIG | 2025-02-24 |