Application 215682
- Type
- ANDA
- Sponsor
- MYLAN PHARMACEUTICALS INC A VIATRIS CO
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 002 | PALIPERIDONE PALMITATE | PALIPERIDONE PALMITATE | INJECTION;SUSPENSION | 410MG/1.315ML | No | No |
| 003 | PALIPERIDONE PALMITATE | PALIPERIDONE PALMITATE | INJECTION;SUSPENSION | 546MG/1.75ML | No | No |
| 004 | PALIPERIDONE PALMITATE | PALIPERIDONE PALMITATE | INJECTION;SUSPENSION | 819MG/2.625ML | No | No |
| 005 | PALIPERIDONE PALMITATE | PALIPERIDONE PALMITATE | INJECTION;SUSPENSION | 1092MG/3.5ML | No | No |
| 006 | PALIPERIDONE PALMITATE | PALIPERIDONE PALMITATE | INJECTION;SUSPENSION | 1560MG/5.0ML | 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 |
|---|---|---|---|---|---|---|
| Erzofri extended-release | PALIPERIDONE PALMITATE | Shandong Luye Pharmaceutical Co., Ltd. | 492bf9dd-868e-421a-92db-8cca8973aac1 | 2026-03-09 | Boxed warning, Warnings, Adverse reactions | PALIPERIDONE PALMITATE |
| INVEGA HAFYERA | PALIPERIDONE PALMITATE | Janssen Pharmaceuticals, Inc | 6cd61892-d2cb-434d-83ed-5c1b2c4e7a0b | 2025-02-18 | Boxed warning, Warnings, Adverse reactions | PALIPERIDONE PALMITATE |
| INVEGA SUSTENNA | PALIPERIDONE PALMITATE | Janssen Pharmaceuticals, Inc. | 1af14e42-951d-414d-8564-5d5fce138554 | 2025-02-14 | Boxed warning, Warnings, Adverse reactions | PALIPERIDONE PALMITATE |
| INVEGA TRINZA | PALIPERIDONE PALMITATE | Janssen Pharmaceuticals, Inc | c39e65d7-fa44-4e4c-8b12-a654d3ed0eae | 2025-02-14 | Boxed warning, Warnings, Adverse reactions | PALIPERIDONE PALMITATE |