Application 209577
- Type
- ANDA
- Sponsor
- SUN PHARM INDUSTRIES
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BOSUTINIB | BOSUTINIB MONOHYDRATE | TABLET;FILM COATED | 400MG | No | No |
| 002 | BOSUTINIB | BOSUTINIB MONOHYDRATE | TABLET;FILM COATED | EQ 100MG BASE | No | No |
| 003 | BOSUTINIB | BOSUTINIB MONOHYDRATE | TABLET;FILM COATED | EQ 500MG BASE | 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 |
|---|---|---|---|---|---|---|
| Bosutinib | BOSUTINIB | Dr. Reddy's Laboratories Inc. | cb7a8d1d-07c0-462d-960f-214d44705e76 | 2026-05-25 | Warnings, Adverse reactions | Bosutinib |
| Bosutinib | BOSUTINIB | Alembic Pharmaceuticals Limited | 8f3e9739-8ec1-4ea9-b1bc-185fd07d84e4 | 2026-05-22 | Warnings, Adverse reactions | Bosutinib |
| Bosutinib | BOSUTINIB | Alembic Pharmaceuticals Inc. | 2ea1617f-41d3-479a-87d5-177013d39193 | 2026-05-20 | Warnings, Adverse reactions | Bosutinib |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 58808 | ORIG | 2019-05-21 |