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Generated: November 19, 2018

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Details for New Drug Application (NDA): 204485

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NDA 204485 describes VASOSTRICT, which is a drug marketed by Par Sterile Products and is included in one NDA. It is available from two suppliers. There are six patents protecting this drug and one Paragraph IV challenge. Additional details are available on the VASOSTRICT profile page.

The generic ingredient in VASOSTRICT is vasopressin. There are nine drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the vasopressin profile page.
Summary for 204485
Tradename:VASOSTRICT
Applicant:Par Sterile Products
Ingredient:vasopressin
Patents:6
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 204485
Generic Entry Date for 204485*:
Constraining patent/regulatory exclusivity:
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.

Suppliers and Packaging for NDA: 204485
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VASOSTRICT vasopressin SOLUTION;IV (INFUSION) 204485 NDA Par Pharmaceutical, Inc. 42023-164 42023-164-25 25 VIAL in 1 CARTON (42023-164-25) > 1 mL in 1 VIAL (42023-164-01)
VASOSTRICT vasopressin SOLUTION;IV (INFUSION) 204485 NDA Par Pharmaceutical, Inc. 42023-190 42023-190-01 1 VIAL in 1 CARTON (42023-190-01) > 10 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;IV (INFUSION)Strength20UNITS/ML (20UNITS/ML)
Approval Date:Apr 17, 2014TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Jan 30, 2035Product Flag?Substance Flag?Delist Request?
Patented Use:TO INCREASE BLOOD PRESSURE IN ADULTS WITH VASODILATORY SHOCK (E.G., POST-CARDIOTOMY OR SEPSIS) WHO REMAIN HYPOTENSIVE DESPITE FLUIDS AND CATECHOLAMINES
Patent:➤ Try a Free TrialPatent Expiration:Jan 30, 2035Product Flag?Substance Flag?Delist Request?
Patented Use:TO INCREASE BLOOD PRESSURE IN ADULTS WITH VASODILATORY SHOCK (E.G., POST-CARDIOTOMY OR SEPSIS) WHO REMAIN HYPOTENSIVE DESPITE FLUIDS AND CATECHOLAMINES
Patent:➤ Try a Free TrialPatent Expiration:Jan 30, 2035Product Flag?Substance Flag?Delist Request?
Patented Use:TO INCREASE BLOOD PRESSURE IN ADULTS WITH VASODILATORY SHOCK (E.G., POST-CARDIOTOMY OR SEPSIS) WHO REMAIN HYPOTENSIVE DESPITE FLUIDS AND CATECHOLAMINES

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