Application 078452
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | RISPERIDONE | RISPERIDONE | SOLUTION;ORAL | 1MG/ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 65862-167 | RISPERIDONE | RISPERIDONE | Aurobindo Pharma Limited | ANDA | Current |
| 65862-167 | RISPERIDONE | RISPERIDONE | Aurobindo Pharma Limited | ANDA | Current |
| 65862-167 | RISPERIDONE | RISPERIDONE | Aurobindo Pharma Limited | ANDA | Current |
| 65862-167 | RISPERIDONE | RISPERIDONE | Aurobindo Pharma Limited | ANDA | Current |
| 65862-167 | RISPERIDONE | RISPERIDONE | Aurobindo Pharma Limited | ANDA | Current |