Application 078465
- Type
- ANDA
- Sponsor
- PHARM ASSOC
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PREDNISOLONE SODIUM PHOSPHATE | PREDNISOLONE SODIUM PHOSPHATE | SOLUTION;ORAL | EQ 10MG BASE/5ML | No | Yes |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0121-0773 | Prednisolone Sodium Phosphate | Prednisolone Sodium Phosphate | Pharmaceutical Associates, Inc. | ANDA | Current |
| 0121-0773 | Prednisolone Sodium Phosphate | Prednisolone Sodium Phosphate | Pharmaceutical Associates, Inc. | ANDA | Current |
| 0121-0773 | Prednisolone Sodium Phosphate | Prednisolone Sodium Phosphate | Pharmaceutical Associates, Inc. | ANDA | Current |
| 23594-510 | Millipred | PREDNISOLONE SODIUM PHOSPHATE | Zylera Pharmaceuticals, L | ANDA | Current |
| 23594-510 | Millipred | PREDNISOLONE SODIUM PHOSPHATE | Cerecor, Inc. | ANDA | Current |