Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 214313

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NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE (NOREPINEPHRINE BITARTRATE)
EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)
Marketing Status: Prescription

Active Ingredient: NOREPINEPHRINE BITARTRATE
Proprietary Name: NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N214313
Product Number: 001
Approval Date: Jan 15, 2021
Applicant Holder Full Name: BAXTER HEALTHCARE CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE (NOREPINEPHRINE BITARTRATE)
EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)
Marketing Status: Prescription

Active Ingredient: NOREPINEPHRINE BITARTRATE
Proprietary Name: NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N214313
Product Number: 002
Approval Date: Jan 15, 2021
Applicant Holder Full Name: BAXTER HEALTHCARE CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE (NOREPINEPHRINE BITARTRATE)
EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)
Marketing Status: Prescription

Active Ingredient: NOREPINEPHRINE BITARTRATE
Proprietary Name: NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N214313
Product Number: 003
Approval Date: Nov 21, 2023
Applicant Holder Full Name: BAXTER HEALTHCARE CORP
Marketing Status:  Prescription
Patent and Exclusivity Information