Product NDC: | 0054-0063 |
Proprietary Name: | Risperidone |
Non Proprietary Name: | Risperidone |
Active Ingredient(s): | 1 mg/mL & nbsp; Risperidone |
Administration Route(s): | ORAL |
Dosage Form(s): | SOLUTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 0054-0063 |
Labeler Name: | Roxane Laboratories, Inc |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA076904 |
Marketing Category: | ANDA |
Start Marketing Date: | 20090729 |
Package NDC: | 0054-0063-44 |
Package Description: | 30 mL in 1 BOTTLE (0054-0063-44) |
NDC Code | 0054-0063-44 |
Proprietary Name | Risperidone |
Package Description | 30 mL in 1 BOTTLE (0054-0063-44) |
Product NDC | 0054-0063 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Risperidone |
Dosage Form Name | SOLUTION |
Route Name | ORAL |
Start Marketing Date | 20090729 |
Marketing Category Name | ANDA |
Labeler Name | Roxane Laboratories, Inc |
Substance Name | RISPERIDONE |
Strength Number | 1 |
Strength Unit | mg/mL |
Pharmaceutical Classes | Atypical Antipsychotic [EPC] |