Skip to contentApplication 078740
- Type
- ANDA
- Sponsor
- WEST WARD PHARMS
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | RISPERIDONE | RISPERIDONE | TABLET;ORAL | 0.25MG | No | No |
| 002 | RISPERIDONE | RISPERIDONE | TABLET;ORAL | 0.5MG | No | No |
| 003 | RISPERIDONE | RISPERIDONE | TABLET;ORAL | 1MG | No | No |
| 004 | RISPERIDONE | RISPERIDONE | TABLET;ORAL | 2MG | No | No |
| 005 | RISPERIDONE | RISPERIDONE | TABLET;ORAL | 3MG | No | No |
| 006 | RISPERIDONE | RISPERIDONE | TABLET;ORAL | 4MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 59115-088 | Risperidone | Risperidone | Hikma Pharmaceutical | ANDA | Current |
| 59115-088 | Risperidone | Risperidone | Hikma Pharmaceutical | ANDA | Current |
| 59115-089 | Risperidone | Risperidone | Hikma Pharmaceutical | ANDA | Current |
| 59115-089 | Risperidone | Risperidone | Hikma Pharmaceutical | ANDA | Current |
| 59115-090 | Risperidone | Risperidone | Hikma Pharmaceutical | ANDA | Current |
| 59115-090 | Risperidone | Risperidone | Hikma Pharmaceutical | ANDA | Current |
| 59115-091 | Risperidone | Risperidone | Hikma Pharmaceutical | ANDA | Current |
| 59115-091 | Risperidone | Risperidone | Hikma Pharmaceutical | ANDA | Current |
| 59115-092 | Risperidone | Risperidone | Hikma Pharmaceutical | ANDA | Current |
| 59115-092 | Risperidone | Risperidone | Hikma Pharmaceutical | ANDA | Current |
| 59115-093 | Risperidone | Risperidone | Hikma Pharmaceutical | ANDA | Current |
| 59115-093 | Risperidone | Risperidone | Hikma Pharmaceutical | ANDA | Current |