Application 212763
- Type
- ANDA
- Sponsor
- ALVOGEN PINE BROOK
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | IBRUTINIB | IBRUTINIB | UNKNOWN | UNKNOWN | No | No |
| 002 | IBRUTINIB | IBRUTINIB | TABLET;ORAL | 280MG | No | No |
| 003 | IBRUTINIB | IBRUTINIB | TABLET;ORAL | 420MG | No | No |
| 004 | IBRUTINIB | IBRUTINIB | TABLET;ORAL | 560MG | 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 |
|---|---|---|---|---|---|---|
| Imbruvica | IBRUTINIB | Pharmacyclics LLC | 0dfd0279-ff17-4ea9-89be-9803c71bab44 | 2025-10-21 | Warnings, Adverse reactions | IBRUTINIB |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 67425 | ORIG | 2021-05-06 |