Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 209360

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GIAPREZA (ANGIOTENSIN II ACETATE)
EQ 0.5MG BASE/ML (EQ 0.5MG BASE/ML)
Marketing Status: Prescription

Active Ingredient: ANGIOTENSIN II ACETATE
Proprietary Name: GIAPREZA
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: EQ 0.5MG BASE/ML (EQ 0.5MG BASE/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N209360
Product Number: 003
Approval Date: Dec 23, 2021
Applicant Holder Full Name: LA JOLLA PHARMA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

GIAPREZA (ANGIOTENSIN II ACETATE)
EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML)
Marketing Status: Prescription

Active Ingredient: ANGIOTENSIN II ACETATE
Proprietary Name: GIAPREZA
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N209360
Product Number: 001
Approval Date: Dec 21, 2017
Applicant Holder Full Name: LA JOLLA PHARMA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

GIAPREZA (ANGIOTENSIN II ACETATE)
EQ 5MG BASE/2ML (EQ 2.5MG BASE/ML)
Marketing Status: Discontinued

Active Ingredient: ANGIOTENSIN II ACETATE
Proprietary Name: GIAPREZA
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: EQ 5MG BASE/2ML (EQ 2.5MG BASE/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N209360
Product Number: 002
Approval Date: Dec 21, 2017
Applicant Holder Full Name: LA JOLLA PHARMA LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information