Details for New Drug Application (NDA): 022562
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NDA 022562 describes CARBAGLU, which is a drug marketed by Recordati Rare and is included in one NDA. It is available from one supplier. Additional details are available on the CARBAGLU profile page.
The generic ingredient in CARBAGLU is carglumic acid. There are two drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the carglumic acid profile page.
The generic ingredient in CARBAGLU is carglumic acid. There are two drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the carglumic acid profile page.
Summary for 022562
| Tradename: | CARBAGLU |
| Applicant: | Recordati Rare |
| Ingredient: | carglumic acid |
| Patents: | 0 |
Pharmacology for NDA: 022562
| Mechanism of Action | Carbamoyl Phosphate Synthetase 1 Activators |
Suppliers and Packaging for NDA: 022562
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CARBAGLU | carglumic acid | TABLET, FOR SUSPENSION;ORAL | 022562 | NDA | Recordati Rare Diseases | 52276-312 | 52276-312-05 | 5 TABLET, FOR SUSPENSION in 1 BOTTLE (52276-312-05) |
| CARBAGLU | carglumic acid | TABLET, FOR SUSPENSION;ORAL | 022562 | NDA | Recordati Rare Diseases | 52276-312 | 52276-312-60 | 60 TABLET, FOR SUSPENSION in 1 BOTTLE (52276-312-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, FOR SUSPENSION;ORAL | Strength | 200MG | ||||
| Approval Date: | Mar 18, 2010 | TE: | AB | RLD: | Yes | ||||
| Regulatory Exclusivity Expiration: | Jan 22, 2028 | ||||||||
| Regulatory Exclusivity Use: | IN PEDIATRIC AND ADULT PATIENTS AS ADJUNCTIVE THERAPY TO STANDARD OF CARE FOR THE TREATMENT OF ACUTE HYPERAMMONEMIA DUE TO PROPIONIC ACIDEMIA (PA) OR METHYLMALONIC ACIDEMIA (MMA) | ||||||||
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