Details for New Drug Application (NDA): 213395
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NDA 213395 describes CARGLUMIC ACID, which is a drug marketed by Navinta Llc and Novitium Pharma and is included in two NDAs. It is available from three suppliers. Additional details are available on the CARGLUMIC ACID profile page.
The generic ingredient in CARGLUMIC ACID 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 CARGLUMIC ACID 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 213395
| Tradename: | CARGLUMIC ACID |
| Applicant: | Navinta Llc |
| Ingredient: | carglumic acid |
| Patents: | 0 |
Pharmacology for NDA: 213395
| Mechanism of Action | Carbamoyl Phosphate Synthetase 1 Activators |
Suppliers and Packaging for NDA: 213395
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CARGLUMIC ACID | carglumic acid | TABLET, FOR SUSPENSION;ORAL | 213395 | ANDA | Burel Pharmaceuticals, LLC | 35573-459 | 35573-459-60 | 60 TABLET, FOR SUSPENSION in 1 BOTTLE (35573-459-60) |
| CARGLUMIC ACID | carglumic acid | TABLET, FOR SUSPENSION;ORAL | 213395 | ANDA | Navinta LLC | 68475-006 | 68475-006-01 | 5 TABLET, FOR SUSPENSION in 1 BOTTLE (68475-006-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, FOR SUSPENSION;ORAL | Strength | 200MG | ||||
| Approval Date: | Jun 22, 2022 | TE: | AB | RLD: | No | ||||
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