Details for New Drug Application (NDA): 212832
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NDA 212832 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 212832
| Tradename: | POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | potassium phosphate, dibasic; potassium phosphate, monobasic |
| Patents: | 2 |
Pharmacology for NDA: 212832
| Mechanism of Action | Osmotic Activity |
| Physiological Effect | Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption |
Suppliers and Packaging for NDA: 212832
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| POTASSIUM PHOSPHATES | potassium phosphate, dibasic; potassium phosphate, monobasic | SOLUTION;INTRAVENOUS | 212832 | NDA | Fresenius Kabi USA, LLC | 65219-052 | 65219-052-29 | 25 VIAL, SINGLE-DOSE in 1 TRAY (65219-052-29) / 5 mL in 1 VIAL, SINGLE-DOSE (65219-052-09) |
| POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE | potassium phosphate, dibasic; potassium phosphate, monobasic | SOLUTION;INTRAVENOUS | 212832 | NDA | Fresenius Kabi USA, LLC | 65219-052 | 65219-052-29 | 25 VIAL, SINGLE-DOSE in 1 TRAY (65219-052-29) / 5 mL in 1 VIAL, SINGLE-DOSE (65219-052-09) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) | ||||
| Approval Date: | Nov 26, 2019 | TE: | AP | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) | ||||
| Approval Date: | Nov 26, 2019 | TE: | AP | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) | ||||
| Approval Date: | Nov 26, 2019 | TE: | AP | RLD: | Yes | ||||
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