Application 203559
- Type
- ANDA
- Sponsor
- EDENBRIDGE PHARMS
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 | No |
| 002 | PREDNISOLONE SODIUM PHOSPHATE | PREDNISOLONE SODIUM PHOSPHATE | SOLUTION;ORAL | EQ 20MG BASE/5ML | No | No |
| 003 | PREDNISOLONE SODIUM PHOSPHATE | PREDNISOLONE SODIUM PHOSPHATE | SOLUTION;ORAL | EQ 15MG BASE/5ML | No | No |
| 004 | PREDNISOLONE SODIUM PHOSPHATE | PREDNISOLONE SODIUM PHOSPHATE | SOLUTION;ORAL | EQ 25MG BASE/5ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 42799-812 | Prednisolone Sodium Phosphate | Prednisolone Sodium Phosphate | Edenbridge Pharmaceuticals, LLC | ANDA | Current |
| 42799-812 | Prednisolone Sodium Phosphate | Prednisolone Sodium Phosphate | Edenbridge Pharmaceuticals LLC. | ANDA | Current |
| 42799-813 | Prednisolone Sodium Phosphate | Prednisolone Sodium Phosphate | Edenbridge Pharmaceuticals, LLC | ANDA | Current |
| 42799-813 | Prednisolone Sodium Phosphate | Prednisolone Sodium Phosphate | Edenbridge Pharmaceuticals LLC. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 46522 | ORIG | 2016-12-23 |