Application 078116
- Type
- ANDA
- Sponsor
- SANDOZ
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | RISPERIDONE | RISPERIDONE | TABLET, ORALLY DISINTEGRATING;ORAL | 0.5MG | No | No |
| 002 | RISPERIDONE | RISPERIDONE | TABLET, ORALLY DISINTEGRATING;ORAL | 1MG | No | No |
| 003 | RISPERIDONE | RISPERIDONE | TABLET, ORALLY DISINTEGRATING;ORAL | 2MG | No | No |
| 004 | RISPERIDONE | RISPERIDONE | TABLET, ORALLY DISINTEGRATING;ORAL | 3MG | No | No |
| 005 | RISPERIDONE | RISPERIDONE | TABLET, ORALLY DISINTEGRATING;ORAL | 4MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0781-5310 | Risperidone | Risperidone | Sandoz Inc | ANDA | Current |
| 0781-5310 | Risperidone | Risperidone | Sandoz Inc | ANDA | Current |
| 0781-5311 | Risperidone | Risperidone | Sandoz Inc | ANDA | Current |
| 0781-5311 | Risperidone | Risperidone | Sandoz Inc | ANDA | Current |
| 0781-5312 | Risperidone | Risperidone | Sandoz Inc | ANDA | Current |
| 0781-5312 | Risperidone | Risperidone | Sandoz Inc | ANDA | Current |
| 0781-5313 | Risperidone | Risperidone | Sandoz Inc | ANDA | Current |
| 0781-5313 | Risperidone | Risperidone | Sandoz Inc | ANDA | Current |
| 0781-5314 | Risperidone | Risperidone | Sandoz Inc | ANDA | Current |
| 0781-5314 | Risperidone | Risperidone | Sandoz Inc | ANDA | Current |