Details for New Drug Application (NDA): 216920
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NDA 216920 describes SODIUM ACETATE, which is a drug marketed by Fresenius Kabi Usa, Hikma, Hospira, and Milla Pharms, and is included in four NDAs. It is available from five suppliers. Additional details are available on the SODIUM ACETATE profile page.
The generic ingredient in SODIUM ACETATE is sodium acetate. There are one thousand four hundred and seventy-two drug master file entries for this compound. Five 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 are one thousand four hundred and seventy-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the sodium acetate profile page.
Summary for 216920
| Tradename: | SODIUM ACETATE |
| Applicant: | Hikma |
| Ingredient: | sodium acetate |
| Patents: | 0 |
Pharmacology for NDA: 216920
| Mechanism of Action | Osmotic Activity |
| Physiological Effect | Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption |
Suppliers and Packaging for NDA: 216920
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SODIUM ACETATE | sodium acetate | SOLUTION;INTRAVENOUS | 216920 | ANDA | Hikma Pharmaceuticals USA Inc. | 0641-6261 | 0641-6261-01 | 1 VIAL in 1 CARTON (0641-6261-01) / 20 mL in 1 VIAL |
| SODIUM ACETATE | sodium acetate | SOLUTION;INTRAVENOUS | 216920 | ANDA | Hikma Pharmaceuticals USA Inc. | 0641-6262 | 0641-6262-01 | 1 VIAL in 1 CARTON (0641-6262-01) / 50 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 40MEQ/20ML (2MEQ/ML) | ||||
| Approval Date: | Mar 15, 2024 | TE: | AP | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Nov 16, 2024 | ||||||||
| Regulatory Exclusivity Use: | COMPETITIVE GENERIC THERAPY | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 100MEQ/50ML (2MEQ/ML) | ||||
| Approval Date: | Mar 15, 2024 | TE: | AP | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 200MEQ/100ML (2MEQ/ML) | ||||
| Approval Date: | Mar 15, 2024 | TE: | AP | RLD: | No | ||||
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