Application 078707
- Type
- ANDA
- Sponsor
- RENATA
Application Products#
| 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 | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 53808-0909 | Risperidone | risperidone | State of Florida DOH Central Pharmacy | ANDA | Current |
| 53808-1048 | Risperidone | risperidone | State of Florida DOH Central Pharmacy | ANDA | Current |
| 63187-209 | Risperidone | risperidone | Proficient Rx LP | ANDA | Current |
| 63187-210 | Risperidone | risperidone | Proficient Rx LP | ANDA | Current |
| 63187-211 | Risperidone | risperidone | Proficient Rx LP | ANDA | Current |
| 63629-3354 | Risperidone | risperidone | Bryant Ranch Prepack | ANDA | Current |
| 63629-3355 | Risperidone | risperidone | Bryant Ranch Prepack | ANDA | Current |
| 63629-4504 | Risperidone | risperidone | Bryant Ranch Prepack | ANDA | Current |
| 63629-4505 | Risperidone | risperidone | Bryant Ranch Prepack | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 44394 | ORIG | 2009-01-06 |