Details for New Drug Application (NDA): 213729
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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 213729
Tradename: | CARGLUMIC ACID |
Applicant: | Novitium Pharma |
Ingredient: | carglumic acid |
Patents: | 0 |
Pharmacology for NDA: 213729
Mechanism of Action | Carbamoyl Phosphate Synthetase 1 Activators |
Suppliers and Packaging for NDA: 213729
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CARGLUMIC ACID | carglumic acid | TABLET, FOR SUSPENSION;ORAL | 213729 | ANDA | Eton Pharmaceuticals, Inc. | 71863-114 | 71863-114-60 | 1 BOTTLE in 1 CARTON (71863-114-60) / 60 TABLET, FOR SUSPENSION in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, FOR SUSPENSION;ORAL | Strength | 200MG | ||||
Approval Date: | Oct 13, 2021 | TE: | AB | RLD: | No |
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