Details for New Drug Application (NDA): 019438
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The generic ingredient in AMINOSYN II 8.5% is amino acids; magnesium chloride; potassium chloride; sodium chloride; sodium phosphate, dibasic. There are three hundred and fifty drug master file entries for this compound. Additional details are available on the amino acids; magnesium chloride; potassium chloride; sodium chloride; sodium phosphate, dibasic profile page.
Summary for 019438
Tradename: | AMINOSYN II 8.5% |
Applicant: | Icu Medical Inc |
Ingredient: | amino acids |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 3.5% (3.5GM/100ML) | ||||
Approval Date: | Apr 3, 1986 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 5% (5GM/100ML) | ||||
Approval Date: | Apr 3, 1986 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 7% (7GM/100ML) | ||||
Approval Date: | Apr 3, 1986 | TE: | RLD: | No |
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