Application 079059
- Type
- ANDA
- Sponsor
- TRIS PHARMA INC
Application Products#
| 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 | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 27808-002 | Risperidone | Risperidone | Tris Pharma Inc | ANDA | Current |
| 27808-002 | Risperidone | Risperidone | Tris Pharma Inc | ANDA | Current |
| 27808-002 | Risperidone | Risperidone | Tris Pharma Inc | ANDA | Current |
| 51991-716 | Risperidone | Risperidone | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-716 | Risperidone | Risperidone | Breckenridge Pharmaceutical, Inc. | ANDA | Current |