| Product NDC: | 52276-312 |
| Proprietary Name: | Carbaglu |
| Non Proprietary Name: | Carglumic Acid |
| Active Ingredient(s): | 200 mg/1 & nbsp; Carglumic Acid |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 52276-312 |
| Labeler Name: | Orphan Europe, SARL |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA022562 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20100318 |
| Package NDC: | 52276-312-60 |
| Package Description: | 60 TABLET in 1 BOTTLE (52276-312-60) |
| NDC Code | 52276-312-60 |
| Proprietary Name | Carbaglu |
| Package Description | 60 TABLET in 1 BOTTLE (52276-312-60) |
| Product NDC | 52276-312 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Carglumic Acid |
| Dosage Form Name | TABLET |
| Route Name | ORAL |
| Start Marketing Date | 20100318 |
| Marketing Category Name | NDA |
| Labeler Name | Orphan Europe, SARL |
| Substance Name | CARGLUMIC ACID |
| Strength Number | 200 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Carbamoyl Phosphate Synthetase 1 Activator [EPC],Carbamoyl Phosphate Synthetase 1 Activators [MoA] |