Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 214628

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NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE (NOREPINEPHRINE BITARTRATE)
EQ 4MG BASE/250 ML (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/250 ML (EQ 16MCG BASE/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N214628
Product Number: 001
Approval Date: Oct 6, 2022
Applicant Holder Full Name: LONG GROVE PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE (NOREPINEPHRINE BITARTRATE)
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: N214628
Product Number: 002
Approval Date: Oct 6, 2022
Applicant Holder Full Name: LONG GROVE PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE (NOREPINEPHRINE BITARTRATE)
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: N214628
Product Number: 003
Approval Date: Oct 6, 2022
Applicant Holder Full Name: LONG GROVE PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information