Application 211085
- Type
- ANDA
- Sponsor
- CIPLA LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VORTIOXETINE | VORTIOXETINE | TABLET;ORAL | 5MG | 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 |
|---|---|---|---|---|---|---|
| Trintellix | VORTIOXETINE | REMEDYREPACK INC. | 239215eb-be32-4286-9677-1e5556c6cccf | 2026-04-23 | Boxed warning, Warnings, Adverse reactions | VORTIOXETINE |
| Trintellix | VORTIOXETINE | REMEDYREPACK INC. | bd0107e5-1cb9-4b40-a6af-fa65fcbe6b4e | 2026-04-23 | Boxed warning, Warnings, Adverse reactions | VORTIOXETINE |
| Trintellix | VORTIOXETINE | Cardinal Health 107, LLC | cb1e9df4-dd74-4073-9d78-bb55593dd000 | 2026-02-17 | Boxed warning, Warnings, Adverse reactions | VORTIOXETINE |
| Trintellix | VORTIOXETINE | Takeda Pharmaceuticals America, Inc. | 1a5b68e2-14d0-419d-9ec6-1ca97145e838 | 2025-03-05 | Boxed warning, Warnings, Adverse reactions | VORTIOXETINE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 60137 | ORIG | 2019-09-27 |