Details for New Drug Application (NDA): 218343
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NDA 218343 describes POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE, which is a drug marketed by Amneal and Fresenius Kabi Usa and is included in two NDAs. It is available from three suppliers. There are two patents protecting this drug. Additional details are available on the POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE profile page.
The generic ingredient in POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE is potassium phosphate, dibasic; potassium phosphate, monobasic. There is one drug master file entry for this compound. Ten suppliers are listed for this compound. Additional details are available on the potassium phosphate, dibasic; potassium phosphate, monobasic profile page.
The generic ingredient in POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE is potassium phosphate, dibasic; potassium phosphate, monobasic. There is one drug master file entry for this compound. Ten suppliers are listed for this compound. Additional details are available on the potassium phosphate, dibasic; potassium phosphate, monobasic profile page.
Summary for 218343
| Tradename: | POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE |
| Applicant: | Amneal |
| Ingredient: | potassium phosphate, dibasic; potassium phosphate, monobasic |
| Patents: | 1 |
Pharmacology for NDA: 218343
| Mechanism of Action | Osmotic Activity |
| Physiological Effect | Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption |
Suppliers and Packaging for NDA: 218343
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE | potassium phosphate, dibasic; potassium phosphate, monobasic | SOLUTION;INTRAVENOUS | 218343 | NDA | Amneal Pharmaceuticals LLC | 70121-1722 | 70121-1722-9 | 24 POUCH in 1 CARTON (70121-1722-9) / 1 BAG in 1 POUCH / 250 mL in 1 BAG |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 1.18GM/250ML (4.72MG/ML);1.12GM/250ML (4.48MG/ML) | ||||
| Approval Date: | Jul 26, 2024 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Oct 12, 2041 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | METHOD TO PROVIDE PHOSPHORUS REPLACEMENT BY ADMINISTERING WITHOUT PRIOR DILUTION AN ISOTONIC, STERILE, AND READY-TO-USE SOLUTION COMPRISING ABOUT 15 MMOL PHOSPHORUS AND ABOUT 22 MEQ POTASSIUM FROM A FLEXIBLE CONTAINER | ||||||||
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