Product Details for NDA 019437
AMINOSYN II 10% W/ ELECTROLYTES (AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE)
10%;102MG/100ML;45MG/100ML;522MG/100ML;410MG/100ML
Marketing Status: Discontinued
7%;102MG/100ML;45MG/100ML;522MG/100ML;410MG/100ML
Marketing Status: Discontinued
8.5%;102MG/100ML;45MG/100ML;522MG/100ML;410MG/100ML
Marketing Status: Discontinued
8.5%;102MG/100ML;492MG/100ML;60MG/100ML;425MG/100ML
Marketing Status: Discontinued
3.5%;30MG/100ML;97MG/100ML;120MG/100ML;49MG/100ML
Marketing Status: Discontinued
10%;102MG/100ML;45MG/100ML;522MG/100ML;410MG/100ML
Marketing Status: Discontinued
Active Ingredient: AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE
Proprietary Name: AMINOSYN II 10% W/ ELECTROLYTES
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 10%;102MG/100ML;45MG/100ML;522MG/100ML;410MG/100ML
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N019437
Product Number: 004
Approval Date: Apr 3, 1986
Applicant Holder Full Name: ICU MEDICAL INC
Marketing Status: Discontinued
Patent and Exclusivity Information
AMINOSYN II 7% W/ ELECTROLYTES (AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE)
Proprietary Name: AMINOSYN II 10% W/ ELECTROLYTES
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 10%;102MG/100ML;45MG/100ML;522MG/100ML;410MG/100ML
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N019437
Product Number: 004
Approval Date: Apr 3, 1986
Applicant Holder Full Name: ICU MEDICAL INC
Marketing Status: Discontinued
Patent and Exclusivity Information
7%;102MG/100ML;45MG/100ML;522MG/100ML;410MG/100ML
Marketing Status: Discontinued
Active Ingredient: AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE
Proprietary Name: AMINOSYN II 7% W/ ELECTROLYTES
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 7%;102MG/100ML;45MG/100ML;522MG/100ML;410MG/100ML
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N019437
Product Number: 006
Approval Date: Apr 3, 1986
Applicant Holder Full Name: ICU MEDICAL INC
Marketing Status: Discontinued
Patent and Exclusivity Information
AMINOSYN II 8.5% W/ ELECTROLYTES (AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE)
Proprietary Name: AMINOSYN II 7% W/ ELECTROLYTES
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 7%;102MG/100ML;45MG/100ML;522MG/100ML;410MG/100ML
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N019437
Product Number: 006
Approval Date: Apr 3, 1986
Applicant Holder Full Name: ICU MEDICAL INC
Marketing Status: Discontinued
Patent and Exclusivity Information
8.5%;102MG/100ML;45MG/100ML;522MG/100ML;410MG/100ML
Marketing Status: Discontinued
Active Ingredient: AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE
Proprietary Name: AMINOSYN II 8.5% W/ ELECTROLYTES
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 8.5%;102MG/100ML;45MG/100ML;522MG/100ML;410MG/100ML
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N019437
Product Number: 005
Approval Date: Apr 3, 1986
Applicant Holder Full Name: ICU MEDICAL INC
Marketing Status: Discontinued
Patent and Exclusivity Information
AMINOSYN II 8.5% W/ELECTROLYTES (AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC)
Proprietary Name: AMINOSYN II 8.5% W/ ELECTROLYTES
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 8.5%;102MG/100ML;45MG/100ML;522MG/100ML;410MG/100ML
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N019437
Product Number: 005
Approval Date: Apr 3, 1986
Applicant Holder Full Name: ICU MEDICAL INC
Marketing Status: Discontinued
Patent and Exclusivity Information
8.5%;102MG/100ML;492MG/100ML;60MG/100ML;425MG/100ML
Marketing Status: Discontinued
Active Ingredient: AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC
Proprietary Name: AMINOSYN II 8.5% W/ELECTROLYTES
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 8.5%;102MG/100ML;492MG/100ML;60MG/100ML;425MG/100ML
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N019437
Product Number: 008
Approval Date: Oct 25, 2002
Applicant Holder Full Name: ICU MEDICAL INC
Marketing Status: Discontinued
Patent and Exclusivity Information
AMINOSYN II 3.5% M (AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE)
Proprietary Name: AMINOSYN II 8.5% W/ELECTROLYTES
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 8.5%;102MG/100ML;492MG/100ML;60MG/100ML;425MG/100ML
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N019437
Product Number: 008
Approval Date: Oct 25, 2002
Applicant Holder Full Name: ICU MEDICAL INC
Marketing Status: Discontinued
Patent and Exclusivity Information
3.5%;30MG/100ML;97MG/100ML;120MG/100ML;49MG/100ML
Marketing Status: Discontinued
Active Ingredient: AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE
Proprietary Name: AMINOSYN II 3.5% M
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 3.5%;30MG/100ML;97MG/100ML;120MG/100ML;49MG/100ML
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N019437
Product Number: 007
Approval Date: Apr 3, 1986
Applicant Holder Full Name: ICU MEDICAL INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: AMINOSYN II 3.5% M
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 3.5%;30MG/100ML;97MG/100ML;120MG/100ML;49MG/100ML
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N019437
Product Number: 007
Approval Date: Apr 3, 1986
Applicant Holder Full Name: ICU MEDICAL INC
Marketing Status: Discontinued
Patent and Exclusivity Information