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 is included in one NDA. It is available from one supplier. 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 are two hundred and forty drug master file entries for this compound. Six 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 are two hundred and forty drug master file entries for this compound. Six 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: | 0 |
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 | |||||
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