| 72526-105-11 |
72526-105 |
HUMAN PRESCRIPTION DRUG |
Erzofri extended-release |
paliperidone palmitate |
INJECTION |
INTRAMUSCULAR |
20241210 |
N/A |
NDA |
NDA216352 |
Shandong Luye Pharmaceutical Co., Ltd. |
PALIPERIDONE PALMITATE |
39 mg/.25mL |
1 SYRINGE, GLASS in 1 KIT (72526-105-11) / .25 mL in 1 SYRINGE, GLASS |
| 72526-106-11 |
72526-106 |
HUMAN PRESCRIPTION DRUG |
Erzofri extended-release |
paliperidone palmitate |
INJECTION |
INTRAMUSCULAR |
20241210 |
N/A |
NDA |
NDA216352 |
Shandong Luye Pharmaceutical Co., Ltd. |
PALIPERIDONE PALMITATE |
78 mg/.5mL |
1 SYRINGE, GLASS in 1 KIT (72526-106-11) / .5 mL in 1 SYRINGE, GLASS |
| 72526-107-11 |
72526-107 |
HUMAN PRESCRIPTION DRUG |
Erzofri extended-release |
paliperidone palmitate |
INJECTION |
INTRAMUSCULAR |
20241210 |
N/A |
NDA |
NDA216352 |
Shandong Luye Pharmaceutical Co., Ltd. |
PALIPERIDONE PALMITATE |
117 mg/.75mL |
1 SYRINGE, GLASS in 1 KIT (72526-107-11) / .75 mL in 1 SYRINGE, GLASS |
| 72526-108-11 |
72526-108 |
HUMAN PRESCRIPTION DRUG |
Erzofri extended-release |
paliperidone palmitate |
INJECTION |
INTRAMUSCULAR |
20241210 |
N/A |
NDA |
NDA216352 |
Shandong Luye Pharmaceutical Co., Ltd. |
PALIPERIDONE PALMITATE |
156 mg/mL |
1 SYRINGE, GLASS in 1 KIT (72526-108-11) / 1 mL in 1 SYRINGE, GLASS |
| 72526-109-11 |
72526-109 |
HUMAN PRESCRIPTION DRUG |
Erzofri extended-release |
paliperidone palmitate |
INJECTION |
INTRAMUSCULAR |
20241210 |
N/A |
NDA |
NDA216352 |
Shandong Luye Pharmaceutical Co., Ltd. |
PALIPERIDONE PALMITATE |
234 mg/1.5mL |
1 SYRINGE, GLASS in 1 KIT (72526-109-11) / 1.5 mL in 1 SYRINGE, GLASS |
| 72526-110-11 |
72526-110 |
HUMAN PRESCRIPTION DRUG |
Erzofri extended-release |
paliperidone palmitate |
INJECTION |
INTRAMUSCULAR |
20241210 |
N/A |
NDA |
NDA216352 |
Shandong Luye Pharmaceutical Co., Ltd. |
PALIPERIDONE PALMITATE |
351 mg/2.25mL |
1 SYRINGE, GLASS in 1 KIT (72526-110-11) / 2.25 mL in 1 SYRINGE, GLASS |
| 72526-110-21 |
72526-110 |
HUMAN PRESCRIPTION DRUG |
Erzofri extended-release |
paliperidone palmitate |
INJECTION |
INTRAMUSCULAR |
20250320 |
N/A |
NDA |
NDA216352 |
Shandong Luye Pharmaceutical Co., Ltd. |
PALIPERIDONE PALMITATE |
351 mg/2.25mL |
1 SYRINGE, GLASS in 1 KIT (72526-110-21) / 2.25 mL in 1 SYRINGE, GLASS |