Details for New Drug Application (NDA): 217515
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NDA 217515 describes POTASSIUM ACETATE, which is a drug marketed by Exela Pharma, Fresenius Kabi Usa, and Hospira, and is included in four NDAs. It is available from three suppliers. Additional details are available on the POTASSIUM ACETATE profile page.
The generic ingredient in POTASSIUM ACETATE is potassium acetate. There are two hundred and forty drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the potassium acetate profile page.
The generic ingredient in POTASSIUM ACETATE is potassium acetate. There are two hundred and forty drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the potassium acetate profile page.
Summary for 217515
| Tradename: | POTASSIUM ACETATE |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | potassium acetate |
| Patents: | 0 |
Pharmacology for NDA: 217515
| Mechanism of Action | Osmotic Activity |
| Physiological Effect | Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption |
Suppliers and Packaging for NDA: 217515
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| POTASSIUM ACETATE | potassium acetate | INJECTABLE;INJECTION | 217515 | ANDA | Fresenius Kabi USA, LLC | 65219-510 | 65219-510-20 | 25 VIAL, SINGLE-DOSE in 1 TRAY (65219-510-20) / 20 mL in 1 VIAL, SINGLE-DOSE (65219-510-02) |
| POTASSIUM ACETATE | potassium acetate | INJECTABLE;INJECTION | 217515 | ANDA | Fresenius Kabi USA, LLC | 65219-512 | 65219-512-50 | 25 VIAL, PHARMACY BULK PACKAGE in 1 TRAY (65219-512-50) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE (65219-512-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 2MEQ/ML | ||||
| Approval Date: | Nov 27, 2024 | TE: | AP | RLD: | No | ||||
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