Details for New Drug Application (NDA): 209997
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The generic ingredient in SODIUM PHOSPHATES is sodium phosphate, dibasic, heptahydrate; sodium phosphate, monobasic, anhydrous. There are one thousand four hundred and seventy-two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the sodium phosphate, dibasic, heptahydrate; sodium phosphate, monobasic, anhydrous profile page.
Summary for 209997
Tradename: | SODIUM PHOSPHATES |
Applicant: | Fresenius Kabi Usa |
Ingredient: | sodium phosphate, dibasic, heptahydrate; sodium phosphate, monobasic, anhydrous |
Patents: | 0 |
Pharmacology for NDA: 209997
Mechanism of Action | Osmotic Activity |
Physiological Effect | Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption |
Suppliers and Packaging for NDA: 209997
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SODIUM PHOSPHATES | sodium phosphate, dibasic, heptahydrate; sodium phosphate, monobasic, anhydrous | INJECTABLE;INJECTION | 209997 | ANDA | Fresenius Kabi USA, LLC | 63323-881 | 63323-881-16 | 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-881-16) / 15 mL in 1 VIAL, SINGLE-DOSE (63323-881-01) |
SODIUM PHOSPHATES | sodium phosphate, dibasic, heptahydrate; sodium phosphate, monobasic, anhydrous | INJECTABLE;INJECTION | 209997 | ANDA | Fresenius Kabi USA, LLC | 63323-884 | 63323-884-06 | 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-884-06) / 5 mL in 1 VIAL, SINGLE-DOSE (63323-884-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 142MG/ML;276MG/ML | ||||
Approval Date: | Mar 30, 2022 | TE: | AP | RLD: | No |
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