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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 215875


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NDA 215875 describes ADRENALIN, which is a drug marketed by Endo Operations and is included in three NDAs. It is available from seven suppliers. There are six patents protecting this drug and one Paragraph IV challenge. Additional details are available on the ADRENALIN profile page.

The generic ingredient in ADRENALIN is epinephrine. There are twenty-one drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the epinephrine profile page.
Summary for 215875
Tradename:ADRENALIN
Applicant:Endo Operations
Ingredient:epinephrine
Patents:3
Suppliers and Packaging for NDA: 215875
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ADRENALIN epinephrine SOLUTION;INTRAVENOUS 215875 NDA Endo USA, Inc. 42023-315 42023-315-10 10 BAG in 1 CARTON (42023-315-10) / 250 mL in 1 BAG (42023-315-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength2MG/250ML (8MCG/ML)
Approval Date:Apr 21, 2023TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Mar 21, 2039Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:Mar 21, 2039Product Flag?Substance Flag?Delist Request?
Patented Use:TO INCREASE MEAN ARTERIAL BLOOD PRESSURE IN ADULT PATIENTS WITH HYPOTENSION ASSOCIATED WITH SEPTIC SHOCK
Patent:⤷  Sign UpPatent Expiration:Mar 21, 2039Product Flag?YSubstance Flag?Delist Request?

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