Details for New Drug Application (NDA): 217526
✉ Email this page to a colleague
NDA 217526 describes SODIUM PHENYLACETATE AND SODIUM BENZOATE, which is a drug marketed by Ailex Pharms Llc, Maia Pharms Inc, and Navinta Llc, and is included in five NDAs. It is available from six suppliers. Additional details are available on the SODIUM PHENYLACETATE AND SODIUM BENZOATE profile page.
The generic ingredient in SODIUM PHENYLACETATE AND SODIUM BENZOATE is sodium benzoate; sodium phenylacetate. There are one thousand four hundred and seventy-two drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the sodium benzoate; sodium phenylacetate profile page.
The generic ingredient in SODIUM PHENYLACETATE AND SODIUM BENZOATE is sodium benzoate; sodium phenylacetate. There are one thousand four hundred and seventy-two drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the sodium benzoate; sodium phenylacetate profile page.
Summary for 217526
| Tradename: | SODIUM PHENYLACETATE AND SODIUM BENZOATE |
| Applicant: | Navinta Llc |
| Ingredient: | sodium benzoate; sodium phenylacetate |
| Patents: | 0 |
Pharmacology for NDA: 217526
| Mechanism of Action | Ammonium Ion Binding Activity |
Suppliers and Packaging for NDA: 217526
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SODIUM PHENYLACETATE AND SODIUM BENZOATE | sodium benzoate; sodium phenylacetate | SOLUTION;INTRAVENOUS | 217526 | ANDA | Zydus Pharmaceuticals USA Inc. | 70710-1926 | 70710-1926-1 | 1 VIAL in 1 CARTON (70710-1926-1) / 20 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 10%;10% (2GM/20ML; 2GM/20ML) | ||||
| Approval Date: | Jul 14, 2023 | TE: | AP | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Mar 17, 2024 | ||||||||
| Regulatory Exclusivity Use: | COMPETITIVE GENERIC THERAPY | ||||||||
Complete Access Available with Subscription
