Product NDC: | 50458-560 |
Proprietary Name: | INVEGA SUSTENNA |
Non Proprietary Name: | paliperidone palmitate |
Active Ingredient(s): | 39 mg/.25mL & nbsp; paliperidone palmitate |
Administration Route(s): | INTRAMUSCULAR |
Dosage Form(s): | INJECTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 50458-560 |
Labeler Name: | Janssen Pharmaceuticals, Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA022264 |
Marketing Category: | NDA |
Start Marketing Date: | 20090731 |
Package NDC: | 50458-560-01 |
Package Description: | 1 SYRINGE in 1 KIT (50458-560-01) > .25 mL in 1 SYRINGE |
NDC Code | 50458-560-01 |
Proprietary Name | INVEGA SUSTENNA |
Package Description | 1 SYRINGE in 1 KIT (50458-560-01) > .25 mL in 1 SYRINGE |
Product NDC | 50458-560 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | paliperidone palmitate |
Dosage Form Name | INJECTION |
Route Name | INTRAMUSCULAR |
Start Marketing Date | 20090731 |
Marketing Category Name | NDA |
Labeler Name | Janssen Pharmaceuticals, Inc. |
Substance Name | PALIPERIDONE PALMITATE |
Strength Number | 39 |
Strength Unit | mg/.25mL |
Pharmaceutical Classes | Atypical Antipsychotic [EPC] |