Details for New Drug Application (NDA): 212121
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NDA 212121 describes POTASSIUM PHOSPHATES, which is a drug marketed by Am Regent, Amneal, Cmp Dev Llc, and Fresenius Kabi Usa, and is included in four NDAs. It is available from three 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. Three 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. Three suppliers are listed for this compound. Additional details are available on the potassium phosphate, dibasic; potassium phosphate, monobasic profile page.
Summary for 212121
| Tradename: | POTASSIUM PHOSPHATES |
| Applicant: | Cmp Dev Llc |
| Ingredient: | potassium phosphate, dibasic; potassium phosphate, monobasic |
| Patents: | 1 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) | ||||
| Approval Date: | Sep 19, 2019 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Apr 19, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | POTASSIUM PHOSPHATES INJECTION IS INDICATED AS A SOURCE OF PHOSPHORUS IN INTRAVENOUS FLUIDS TO CORRECT HYPOPHOSPHATEMIA IN ADULTS AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER | ||||||||
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