Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 019438

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AMINOSYN II 10% (AMINO ACIDS)
10% (10GM/100ML)
Marketing Status: Discontinued

Active Ingredient: AMINO ACIDS
Proprietary Name: AMINOSYN II 10%
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 10% (10GM/100ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N019438
Product Number: 005
Approval Date: Apr 3, 1986
Applicant Holder Full Name: ICU MEDICAL INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

AMINOSYN II 3.5% (AMINO ACIDS)
3.5% (3.5GM/100ML)
Marketing Status: Discontinued

Active Ingredient: AMINO ACIDS
Proprietary Name: AMINOSYN II 3.5%
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 3.5% (3.5GM/100ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N019438
Product Number: 001
Approval Date: Apr 3, 1986
Applicant Holder Full Name: ICU MEDICAL INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

AMINOSYN II 5% (AMINO ACIDS)
5% (5GM/100ML)
Marketing Status: Discontinued

Active Ingredient: AMINO ACIDS
Proprietary Name: AMINOSYN II 5%
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 5% (5GM/100ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N019438
Product Number: 002
Approval Date: Apr 3, 1986
Applicant Holder Full Name: ICU MEDICAL INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

AMINOSYN II 7% (AMINO ACIDS)
7% (7GM/100ML)
Marketing Status: Discontinued

Active Ingredient: AMINO ACIDS
Proprietary Name: AMINOSYN II 7%
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 7% (7GM/100ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N019438
Product Number: 003
Approval Date: Apr 3, 1986
Applicant Holder Full Name: ICU MEDICAL INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

AMINOSYN II 8.5% (AMINO ACIDS)
8.5% (8.5GM/100ML)
Marketing Status: Discontinued

Active Ingredient: AMINO ACIDS
Proprietary Name: AMINOSYN II 8.5%
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 8.5% (8.5GM/100ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N019438
Product Number: 004
Approval Date: Apr 3, 1986
Applicant Holder Full Name: ICU MEDICAL INC
Marketing Status:  Discontinued
Patent and Exclusivity Information