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, 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 212121
| Tradename: | POTASSIUM PHOSPHATES |
| Applicant: | Cmp Dev Llc |
| Ingredient: | potassium phosphate, dibasic; potassium phosphate, monobasic |
| Patents: | 1 |
Suppliers and Packaging for NDA: 212121
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| POTASSIUM PHOSPHATES | potassium phosphate, dibasic; potassium phosphate, monobasic | SOLUTION;INTRAVENOUS | 212121 | NDA | CMP PHARMA, INC. | 46287-024 | 46287-024-10 | 10 VIAL, SINGLE-DOSE in 1 CARTON (46287-024-10) / 15 mL in 1 VIAL, SINGLE-DOSE |
| POTASSIUM PHOSPHATES | potassium phosphate, dibasic; potassium phosphate, monobasic | SOLUTION;INTRAVENOUS | 212121 | NDA | CMP PHARMA, INC. | 46287-024 | 46287-024-15 | 1 VIAL, SINGLE-DOSE in 1 CARTON (46287-024-15) / 15 mL in 1 VIAL, SINGLE-DOSE |
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: | ⤷ Sign Up | 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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