Details for New Drug Application (NDA): 219826
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NDA 219826 describes SODIUM ACETATE, which is a drug marketed by Amneal, Extrovis, Fresenius Kabi Usa, Hikma, Hospira, Milla Pharms, and Somerset Theraps Llc, and is included in seven NDAs. It is available from six suppliers. Additional details are available on the SODIUM ACETATE profile page.
The generic ingredient in SODIUM ACETATE is sodium acetate. There is one drug master file entry for this compound. Six suppliers are listed for this compound. Additional details are available on the sodium acetate profile page.
The generic ingredient in SODIUM ACETATE is sodium acetate. There is one drug master file entry for this compound. Six suppliers are listed for this compound. Additional details are available on the sodium acetate profile page.
Summary for 219826
| Tradename: | SODIUM ACETATE |
| Applicant: | Somerset Theraps Llc |
| Ingredient: | sodium acetate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 219826
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SODIUM ACETATE | sodium acetate | SOLUTION;INTRAVENOUS | 219826 | ANDA | Somerset Therapeutics, LLC | 70069-047 | 70069-047-25 | 25 VIAL, GLASS in 1 CARTON (70069-047-25) / 50 mL in 1 VIAL, GLASS |
| SODIUM ACETATE | sodium acetate | SOLUTION;INTRAVENOUS | 219826 | ANDA | Somerset Therapeutics, LLC | 70069-048 | 70069-048-20 | 20 VIAL, GLASS in 1 CARTON (70069-048-20) / 100 mL in 1 VIAL, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 100MEQ/50ML (2MEQ/ML) | ||||
| Approval Date: | Sep 18, 2025 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 200MEQ/100ML (2MEQ/ML) | ||||
| Approval Date: | Sep 18, 2025 | TE: | AP | RLD: | No | ||||
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