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Generated: November 12, 2018

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Details for New Drug Application (NDA): 209360

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NDA 209360 describes GIAPREZA, which is a drug marketed by La Jolla Pharma and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the GIAPREZA profile page.

The generic ingredient in GIAPREZA is angiotensin ii acetate. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the angiotensin ii acetate profile page.
Summary for 209360
Tradename:GIAPREZA
Applicant:La Jolla Pharma
Ingredient:angiotensin ii acetate
Patents:4
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 209360
Generic Entry Date for 209360*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY
Dosage:
SOLUTION;IV (INFUSION)

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 209360
Physiological EffectVasoconstriction
Medical Subject Heading (MeSH) Categories for 209360
Suppliers and Packaging for NDA: 209360
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GIAPREZA angiotensin ii acetate SOLUTION;INTRAVENOUS 209360 NDA La Jolla Pharmaceutical Company 68547-501 68547-501-02 1 VIAL, SINGLE-DOSE in 1 CARTON (68547-501-02) > 1 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrengthEQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML)
Approval Date:Dec 21, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 21, 2022
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:➤ Sign UpPatent Expiration:Dec 18, 2034Product Flag?Substance Flag?Delist Request?
Patented Use:MAINTAINING MEAN ARTERIAL PRESSURE OF ABOUT 65 MMHG OR ABOVE WITH ABOUT 1 NG/KG/MIN TO ABOUT 40 NG/KG/MIN ANGIOTENSIN II IN HYPOTENSIVE PATIENTS TREATED WITH VASOPRESSIN OR A VASOPRESSIN ANALOGUE AND REDUCING VASOPRESSIN OR VASOPRESSIN ANALOGUE USE
Patent:➤ Sign UpPatent Expiration:Dec 18, 2034Product Flag?Substance Flag?Delist Request?
Patented Use:MAINTAINING MEAN ARTERIAL PRESSURE OF ABOUT 65 MMHG OR HIGHER WITH ANGIOTENSIN II IN SHOCK PATIENTS TREATED WITH CATECHOLAMINES AND REDUCING CATECHOLAMINE USE

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