Application 202179
- Type
- ANDA
- Sponsor
- MYLAN PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PREDNISOLONE SODIUM PHOSPHATE | PREDNISOLONE SODIUM PHOSPHATE | TABLET, ORALLY DISINTEGRATING;ORAL | EQ 10MG BASE | No | No |
| 002 | PREDNISOLONE SODIUM PHOSPHATE | PREDNISOLONE SODIUM PHOSPHATE | TABLET, ORALLY DISINTEGRATING;ORAL | EQ 15MG BASE | No | No |
| 003 | PREDNISOLONE SODIUM PHOSPHATE | PREDNISOLONE SODIUM PHOSPHATE | TABLET, ORALLY DISINTEGRATING;ORAL | EQ 30MG BASE | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-4710 | Prednisolone Sodium Phosphate | prednisolone | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4710 | Prednisolone Sodium Phosphate | prednisolone | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4715 | Prednisolone Sodium Phosphate | prednisolone | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4715 | Prednisolone Sodium Phosphate | prednisolone | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4730 | Prednisolone Sodium Phosphate | prednisolone | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4730 | Prednisolone Sodium Phosphate | prednisolone | Mylan Pharmaceuticals Inc. | ANDA | Current |