Application 212807
- Type
- ANDA
- Sponsor
- CSPC OUYI
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PALIPERIDONE | PALIPERIDONE | TABLET, EXTENDED RELEASE;ORAL | 1.5MG | No | No |
| 002 | PALIPERIDONE | PALIPERIDONE | TABLET, EXTENDED RELEASE;ORAL | 3MG | No | No |
| 003 | PALIPERIDONE | PALIPERIDONE | TABLET, EXTENDED RELEASE;ORAL | 6MG | No | No |
| 004 | PALIPERIDONE | PALIPERIDONE | TABLET, EXTENDED RELEASE;ORAL | 9MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 27808-222 | Paliperidone | paliperidone | Tris Pharma Inc | ANDA | Current |
| 27808-222 | Paliperidone | paliperidone | Tris Pharma Inc | ANDA | Current |
| 27808-223 | Paliperidone | paliperidone | Tris Pharma Inc | ANDA | Current |
| 27808-223 | Paliperidone | paliperidone | Tris Pharma Inc | ANDA | Current |
| 27808-224 | Paliperidone | paliperidone | Tris Pharma Inc | ANDA | Current |
| 27808-224 | Paliperidone | paliperidone | Tris Pharma Inc | ANDA | Current |
| 27808-225 | Paliperidone | paliperidone | Tris Pharma Inc | ANDA | Current |
| 27808-225 | Paliperidone | paliperidone | Tris Pharma Inc | ANDA | Current |