Application 216715
- Type
- ANDA
- Sponsor
- AMNEALS PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PREDNISOLONE SODIUM PHOSPHATE | PREDNISOLONE SODIUM PHOSPHATE | SOLUTION;ORAL | EQ 15MG BASE/5ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 69238-2122 | Prednisolone Sodium Phosphate | Prednisolone Sodium Phosphate | Amneal Pharmaceuticals NY LLC | ANDA | Current |