Application 022043
- Type
- NDA
- Sponsor
- JANSSEN LP
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | INVEGA | PALIPERIDONE | TABLET, EXTENDED RELEASE; ORAL | 3MG | No | No |
| 002 | INVEGA | PALIPERIDONE | TABLET, EXTENDED RELEASE; ORAL | 6MG | No | No |
| 003 | INVEGA | PALIPERIDONE | TABLET, EXTENDED RELEASE; ORAL | 9MG | No | No |
| 004 | INVEGA | PALIPERIDONE | TABLET, EXTENDED RELEASE; ORAL | 12MG | 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 |
|---|---|---|---|---|---|---|
| Paliperidone | PALIPERIDONE | Coupler LLC | 313538c9-01d3-1558-e063-6394a90aa21d | 2025-03-25 | Boxed warning, Warnings, Adverse reactions | PALIPERIDONE |
| paliperidone | PALIPERIDONE | Alembic Pharmaceuticals Inc. | 45fc28d1-132f-413b-a407-dc90e1229ee2 | 2025-02-25 | Boxed warning, Warnings, Adverse reactions | PALIPERIDONE |
| INVEGA | PALIPERIDONE | Janssen Pharmaceuticals, Inc. | 7b8e5b26-b9e4-4704-921b-3c3c0d159916 | 2025-01-31 | Boxed warning, Warnings, Adverse reactions | INVEGA PALIPERIDONE |
| paliperidone | PALIPERIDONE | Alembic Pharmaceuticals Limited | be30f3cc-55fb-4a74-9778-60573a7f18c6 | 2024-09-30 | Boxed warning, Warnings, Adverse reactions | PALIPERIDONE |
| Paliperidone | PALIPERIDONE | Tris Pharma Inc | d7033e52-3df2-48e2-adda-15a57c2f148f | 2024-07-30 | Boxed warning, Warnings, Adverse reactions | PALIPERIDONE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.