Details for New Drug Application (NDA): 216274
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NDA 216274 describes POTASSIUM PHOSPHATES, which is a drug marketed by Am Regent, Amneal, Cmp Dev Llc, Fresenius Kabi Usa, and Somerset Theraps Llc, and is included in six NDAs. It is available from five suppliers. There is one patent protecting this drug. Additional details are available on the POTASSIUM PHOSPHATES profile page.
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. 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 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 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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