Details for New Drug Application (NDA): 216344
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NDA 216344 describes POTASSIUM PHOSPHATES, which is a drug marketed by Am Regent, Amneal, Caplin, Cipla, Cmp Dev Llc, Fresenius Kabi Usa, Hospira, and Somerset Theraps Llc, and is included in nine NDAs. It is available from nine suppliers. There are three patents 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 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 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 216344
| Tradename: | POTASSIUM PHOSPHATES |
| Applicant: | Amneal |
| Ingredient: | potassium phosphate, dibasic; potassium phosphate, monobasic |
| Patents: | 0 |
Pharmacology for NDA: 216344
| Mechanism of Action | Osmotic Activity |
| Physiological Effect | Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption |
Suppliers and Packaging for NDA: 216344
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| POTASSIUM PHOSPHATES | potassium phosphate, dibasic; potassium phosphate, monobasic | SOLUTION;INTRAVENOUS | 216344 | ANDA | Amneal Pharmaceuticals Private Limited | 80830-1691 | 80830-1691-7 | 10 VIAL, SINGLE-DOSE in 1 CARTON (80830-1691-7) / 15 mL in 1 VIAL, SINGLE-DOSE (80830-1691-6) |
| POTASSIUM PHOSPHATES | potassium phosphate, dibasic; potassium phosphate, monobasic | SOLUTION;INTRAVENOUS | 216344 | ANDA | Amneal Pharmaceuticals Private Limited | 80830-1691 | 80830-1691-9 | 10 VIAL, SINGLE-DOSE in 1 CARTON (80830-1691-9) / 15 mL in 1 VIAL, SINGLE-DOSE (80830-1691-3) |
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 10, 2023 | TE: | AP | RLD: | No | ||||
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 10, 2023 | TE: | AP | RLD: | No | ||||
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 10, 2023 | TE: | AP | RLD: | No | ||||
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