Product Details for NDA 215700
NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE (NOREPINEPHRINE BITARTRATE)
EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)
Marketing Status: Prescription
EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)
Marketing Status: Prescription
EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)
Marketing Status: Prescription
EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)
Marketing Status: Prescription
Active Ingredient: NOREPINEPHRINE BITARTRATE
Proprietary Name: NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE
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: N215700
Product Number: 001
Approval Date: Sep 15, 2022
Applicant Holder Full Name: INFORLIFE SA
Marketing Status: Prescription
Patent and Exclusivity Information
NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE (NOREPINEPHRINE BITARTRATE)
Proprietary Name: NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE
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: N215700
Product Number: 001
Approval Date: Sep 15, 2022
Applicant Holder Full Name: INFORLIFE SA
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)
Marketing Status: Prescription
Active Ingredient: NOREPINEPHRINE BITARTRATE
Proprietary Name: NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE
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: N215700
Product Number: 002
Approval Date: Sep 15, 2022
Applicant Holder Full Name: INFORLIFE SA
Marketing Status: Prescription
Patent and Exclusivity Information
NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE (NOREPINEPHRINE BITARTRATE)
Proprietary Name: NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE
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: N215700
Product Number: 002
Approval Date: Sep 15, 2022
Applicant Holder Full Name: INFORLIFE SA
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)
Marketing Status: Prescription
Active Ingredient: NOREPINEPHRINE BITARTRATE
Proprietary Name: NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE
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: N215700
Product Number: 003
Approval Date: Sep 15, 2022
Applicant Holder Full Name: INFORLIFE SA
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE
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: N215700
Product Number: 003
Approval Date: Sep 15, 2022
Applicant Holder Full Name: INFORLIFE SA
Marketing Status: Prescription
Patent and Exclusivity Information