Details for New Drug Application (NDA): 016822
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NDA 016822 describes FREAMINE III 8.5% W/ ELECTROLYTES, which is a drug marketed by B Braun and is included in one NDA. It is available from one supplier. Additional details are available on the FREAMINE III 8.5% W/ ELECTROLYTES profile page.
The generic ingredient in FREAMINE III 8.5% W/ ELECTROLYTES is amino acids; magnesium acetate; phosphoric acid; potassium acetate; potassium chloride; sodium acetate. There are three hundred and fifty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the amino acids; magnesium acetate; phosphoric acid; potassium acetate; potassium chloride; sodium acetate profile page.
The generic ingredient in FREAMINE III 8.5% W/ ELECTROLYTES is amino acids; magnesium acetate; phosphoric acid; potassium acetate; potassium chloride; sodium acetate. There are three hundred and fifty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the amino acids; magnesium acetate; phosphoric acid; potassium acetate; potassium chloride; sodium acetate profile page.
Summary for 016822
| Tradename: | FREAMINE III 8.5% W/ ELECTROLYTES |
| Applicant: | B Braun |
| Ingredient: | amino acids; magnesium acetate; phosphoric acid; potassium acetate; potassium chloride; sodium acetate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 016822
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FREAMINE 8.5% | amino acids | INJECTABLE;INJECTION | 016822 | NDA | B. Braun Medical Inc. | 0264-9010 | 0264-9010-55 | 6 CARTON in 1 CASE (0264-9010-55) / 1 CONTAINER in 1 CARTON / 1000 mL in 1 CONTAINER |
| FREAMINE HBC 6.9% | amino acids | INJECTABLE;INJECTION | 016822 | NDA | B. Braun Medical Inc. | 0264-9010 | 0264-9010-55 | 6 CARTON in 1 CASE (0264-9010-55) / 1 CONTAINER in 1 CARTON / 1000 mL in 1 CONTAINER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 8.5% (8.5GM/100ML) | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 8.5% (8.5GM/100ML) | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 3%;54MG/100ML;40MG/100ML;150MG/100ML;200MG/100ML;120MG/100ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
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