Details for New Drug Application (NDA): 216274
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The generic ingredient in POTASSIUM PHOSPHATES is potassium phosphate, dibasic; potassium phosphate, monobasic. There are two hundred and forty drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the potassium phosphate, dibasic; potassium phosphate, monobasic profile page.
Summary for 216274
Tradename: | POTASSIUM PHOSPHATES |
Applicant: | Am Regent |
Ingredient: | potassium phosphate, dibasic; potassium phosphate, monobasic |
Patents: | 0 |
Pharmacology for NDA: 216274
Mechanism of Action | Osmotic Activity |
Physiological Effect | Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption |
Suppliers and Packaging for NDA: 216274
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
POTASSIUM PHOSPHATES | potassium phosphate, dibasic; potassium phosphate, monobasic | SOLUTION;INTRAVENOUS | 216274 | ANDA | American Regent, Inc. | 0517-2051 | 0517-2051-25 | 25 VIAL, SINGLE-DOSE in 1 TRAY (0517-2051-25) / 5 mL in 1 VIAL, SINGLE-DOSE (0517-2051-01) |
POTASSIUM PHOSPHATES | potassium phosphate, dibasic; potassium phosphate, monobasic | SOLUTION;INTRAVENOUS | 216274 | ANDA | American Regent, Inc. | 0517-2102 | 0517-2102-25 | 25 VIAL, SINGLE-DOSE in 1 TRAY (0517-2102-25) / 15 mL in 1 VIAL, SINGLE-DOSE (0517-2102-01) |
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: | Oct 2, 2023 | TE: | AP | RLD: | No | ||||
Regulatory Exclusivity Expiration: | Apr 13, 2024 | ||||||||
Regulatory Exclusivity Use: | COMPETITIVE GENERIC THERAPY |
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: | Oct 2, 2023 | TE: | AP | RLD: | No | ||||
Regulatory Exclusivity Expiration: | Apr 10, 2024 | ||||||||
Regulatory Exclusivity Use: | COMPETITIVE GENERIC THERAPY |
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: | Oct 2, 2023 | TE: | AP | RLD: | No | ||||
Regulatory Exclusivity Expiration: | Apr 10, 2024 | ||||||||
Regulatory Exclusivity Use: | COMPETITIVE GENERIC THERAPY |
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