Application 075117
- Type
- ANDA
- Sponsor
- CONCORDIA PHARMS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ORAPRED | PREDNISOLONE SODIUM PHOSPHATE | SOLUTION;ORAL | EQ 15MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 42938 | ORIG | 2000-12-14 |
| 39454 | ORIG | 2000-12-14 |
| 30762 | ORIG | 2000-12-14 |