Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 016822

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

Active Ingredient: AMINO ACIDS
Proprietary Name: FREAMINE 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: N016822
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: B BRAUN MEDICAL INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

FREAMINE HBC 6.9% (AMINO ACIDS)
6.9% (6.9GM/100ML)
Marketing Status: Discontinued

Active Ingredient: AMINO ACIDS
Proprietary Name: FREAMINE HBC 6.9%
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 6.9% (6.9GM/100ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N016822
Product Number: 006
Approval Date: May 17, 1983
Applicant Holder Full Name: B BRAUN MEDICAL INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

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

Active Ingredient: AMINO ACIDS
Proprietary Name: FREAMINE 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: N016822
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: B BRAUN MEDICAL INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

FREAMINE III 10% (AMINO ACIDS)
10% (10GM/100ML)
Marketing Status: Discontinued

Active Ingredient: AMINO ACIDS
Proprietary Name: FREAMINE III 10%
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 10% (10GM/100ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N016822
Product Number: 005
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: B BRAUN MEDICAL INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

FREAMINE III 8.5% (AMINO ACIDS)
8.5% (8.5GM/100ML)
Marketing Status: Discontinued

Active Ingredient: AMINO ACIDS
Proprietary Name: FREAMINE III 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: N016822
Product Number: 004
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: B BRAUN MEDICAL INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

FREAMINE III 8.5% W/ ELECTROLYTES (AMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM ACETATE; POTASSIUM CHLORIDE; SODIUM ACETATE)
8.5%;110MG/100ML;230MG/100ML;10MG/100ML;440MG/100ML;690MG/100ML
Marketing Status: Discontinued

Active Ingredient: AMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM ACETATE; POTASSIUM CHLORIDE; SODIUM ACETATE
Proprietary Name: FREAMINE III 8.5% W/ ELECTROLYTES
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 8.5%;110MG/100ML;230MG/100ML;10MG/100ML;440MG/100ML;690MG/100ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N016822
Product Number: 007
Approval Date: Jul 1, 1988
Applicant Holder Full Name: B BRAUN MEDICAL INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

FREAMINE III 3% W/ ELECTROLYTES (AMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE)
3%;54MG/100ML;40MG/100ML;150MG/100ML;200MG/100ML;120MG/100ML
Marketing Status: Discontinued

Active Ingredient: AMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE
Proprietary Name: FREAMINE III 3% W/ ELECTROLYTES
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 3%;54MG/100ML;40MG/100ML;150MG/100ML;200MG/100ML;120MG/100ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N016822
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: B BRAUN MEDICAL INC
Marketing Status:  Discontinued
Patent and Exclusivity Information