Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 019626

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DEXTROSE 10% IN PLASTIC CONTAINER (DEXTROSE)
10GM/100ML
Marketing Status: Prescription
Active Ingredient: DEXTROSE
Proprietary Name: DEXTROSE 10% IN PLASTIC CONTAINER
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 10GM/100ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N019626
Product Number: 004
Approval Date: Feb 2, 1988
Applicant Holder Full Name: B BRAUN MEDICAL INC
Marketing Status:  Prescription
Patent and Exclusivity Information
DEXTROSE 5% IN PLASTIC CONTAINER (DEXTROSE)
5GM/100ML
Marketing Status: Prescription
Active Ingredient: DEXTROSE
Proprietary Name: DEXTROSE 5% IN PLASTIC CONTAINER
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 5GM/100ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N019626
Product Number: 002
Approval Date: Feb 2, 1988
Applicant Holder Full Name: B BRAUN MEDICAL INC
Marketing Status:  Prescription
Patent and Exclusivity Information
DEXTROSE 70% IN PLASTIC CONTAINER (DEXTROSE)
70GM/100ML
Marketing Status: Prescription
Active Ingredient: DEXTROSE
Proprietary Name: DEXTROSE 70% IN PLASTIC CONTAINER
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 70GM/100ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N019626
Product Number: 005
Approval Date: Feb 18, 2015
Applicant Holder Full Name: B BRAUN MEDICAL INC
Marketing Status:  Prescription
Patent and Exclusivity Information
DEXTROSE 2.5% IN PLASTIC CONTAINER (DEXTROSE)
2.5GM/100ML
Marketing Status: Discontinued
Active Ingredient: DEXTROSE
Proprietary Name: DEXTROSE 2.5% IN PLASTIC CONTAINER
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 2.5GM/100ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N019626
Product Number: 001
Approval Date: Feb 2, 1988
Applicant Holder Full Name: B BRAUN MEDICAL INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
DEXTROSE 7.7% IN PLASTIC CONTAINER (DEXTROSE)
7.7GM/100ML
Marketing Status: Discontinued
Active Ingredient: DEXTROSE
Proprietary Name: DEXTROSE 7.7% IN PLASTIC CONTAINER
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 7.7GM/100ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N019626
Product Number: 003
Approval Date: Feb 2, 1988
Applicant Holder Full Name: B BRAUN MEDICAL INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

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