Application 077542
- Type
- ANDA
- Sponsor
- SUN PHARM INDS LTD
Application Products#
Product, Drug, Ingredient table| 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 |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 63304-949 | Risperidone | Risperidone | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 63304-949 | Risperidone | Risperidone | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 63304-949 | Risperidone | Risperidone | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 63304-950 | Risperidone | Risperidone | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 63304-950 | Risperidone | Risperidone | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 63304-950 | Risperidone | Risperidone | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 63304-951 | Risperidone | Risperidone | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 63304-951 | Risperidone | Risperidone | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 63304-951 | Risperidone | Risperidone | Sun Pharmaceutical Industries, Inc. | ANDA | Current |