Skip to contentApplication 078871
- Type
- ANDA
- Sponsor
- CELLTRION
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 |
|---|
| 53808-0565 | Risperidone | RISPERIDONE | DOH CENTRAL PHARMACY | ANDA | Current |
| 55648-553 | RISPERIDONE | RISPERIDONE | WOCKHARDT LIMITED | ANDA | Current |
| 55648-554 | RISPERIDONE | RISPERIDONE | WOCKHARDT LIMITED | ANDA | Current |
| 55648-555 | RISPERIDONE | RISPERIDONE | WOCKHARDT LIMITED | ANDA | Current |
| 55648-557 | RISPERIDONE | RISPERIDONE | WOCKHARDT LIMITED | ANDA | Current |
| 55648-571 | RISPERIDONE | RISPERIDONE | WOCKHARDT LIMITED | ANDA | Current |
| 55648-572 | RISPERIDONE | RISPERIDONE | WOCKHARDT LIMITED | ANDA | Current |
| 64679-553 | Risperidone | Risperidone | Wockhardt USA LLC. | ANDA | Current |
| 64679-554 | Risperidone | Risperidone | Wockhardt USA LLC. | ANDA | Current |
| 64679-555 | Risperidone | Risperidone | Wockhardt USA LLC. | ANDA | Current |
| 64679-557 | Risperidone | Risperidone | Wockhardt USA LLC. | ANDA | Current |
| 64679-571 | Risperidone | Risperidone | Wockhardt USA LLC. | ANDA | Current |
| 64679-572 | Risperidone | Risperidone | Wockhardt USA LLC. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 23925 | ORIG | 2008-11-25 |