| Product NDC: | 13925-501 |
| Proprietary Name: | PREDNISOLONE SODIUM PHOSPHATE |
| Non Proprietary Name: | PREDNISOLONE SODIUM PHOSPHATE |
| Active Ingredient(s): | 5 mg/5mL & nbsp; PREDNISOLONE SODIUM PHOSPHATE |
| Administration Route(s): | ORAL |
| Dosage Form(s): | SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 13925-501 |
| Labeler Name: | Seton Pharmaceuticals |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA075183 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20121201 |
| Package NDC: | 13925-501-04 |
| Package Description: | 120 mL in 1 BOTTLE (13925-501-04) |
| NDC Code | 13925-501-04 |
| Proprietary Name | PREDNISOLONE SODIUM PHOSPHATE |
| Package Description | 120 mL in 1 BOTTLE (13925-501-04) |
| Product NDC | 13925-501 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | PREDNISOLONE SODIUM PHOSPHATE |
| Dosage Form Name | SOLUTION |
| Route Name | ORAL |
| Start Marketing Date | 20121201 |
| Marketing Category Name | ANDA |
| Labeler Name | Seton Pharmaceuticals |
| Substance Name | PREDNISOLONE SODIUM PHOSPHATE |
| Strength Number | 5 |
| Strength Unit | mg/5mL |
| Pharmaceutical Classes | Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] |