Application 216352
- Type
- NDA
- Sponsor
- LUYE INNOMIND PHARMA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ERZOFRI | PALIPERIDONE PALMITATE | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 39MG/0.25ML (39MG/0.25ML) | Yes | Yes |
| 002 | ERZOFRI | PALIPERIDONE PALMITATE | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 78MG/0.5ML (78MG/0.5ML) | Yes | Yes |
| 003 | ERZOFRI | PALIPERIDONE PALMITATE | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 117MG/0.75ML (117MG/0.75ML) | Yes | Yes |
| 004 | ERZOFRI | PALIPERIDONE PALMITATE | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 156MG/ML (156MG/ML) | Yes | Yes |
| 005 | ERZOFRI | PALIPERIDONE PALMITATE | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 234MG/1.5ML (156MG/ML) | Yes | Yes |
| 006 | ERZOFRI | PALIPERIDONE PALMITATE | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 351MG/2.25ML (156MG/ML) | Yes | Yes |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 82434 | ORIG | 2025-06-02 |
| 81100 | SUPPL | 2025-02-06 |
| 81003 | SUPPL | 2025-02-05 |
| 79248 | ORIG | 2024-07-29 |
| 79241 | ORIG | 2024-07-29 |