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: | 52276-312-05 |
Package Description: | 5 TABLET in 1 BOTTLE (52276-312-05) |
NDC Code | 52276-312-05 |
Proprietary Name | Carbaglu |
Package Description | 5 TABLET in 1 BOTTLE (52276-312-05) |
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] |