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Last Updated: January 27, 2023

Details for New Drug Application (NDA): 204640


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NDA 204640 describes ADRENALIN, which is a drug marketed by Par Sterile Products and is included in two NDAs. It is available from nine suppliers. There are three 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-five suppliers are listed for this compound. Additional details are available on the epinephrine profile page.
Summary for 204640
Tradename:ADRENALIN
Applicant:Par Sterile Products
Ingredient:epinephrine
Patents:3
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 204640
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ADRENALIN epinephrine SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS 204640 NDA Par Pharmaceutical, Inc. 42023-168 42023-168-01 1 VIAL in 1 CARTON (42023-168-01) / 30 mL in 1 VIAL
ADRENALIN epinephrine SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS 204640 NDA Par Pharmaceutical, Inc. 42023-168 42023-168-99 1 VIAL in 1 CARTON (42023-168-99) / 30 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSStrengthEQ 30MG BASE/30ML (EQ 1MG BASE/ML)
Approval Date:Dec 18, 2013TE:APRLD:Yes
Patent:See Plans and PricingPatent Expiration:Mar 13, 2035Product Flag?YSubstance Flag?Delist Request?
Patent:See Plans and PricingPatent Expiration:Mar 13, 2035Product Flag?YSubstance Flag?Delist Request?
Patent:See Plans and PricingPatent Expiration:Mar 13, 2035Product Flag?Substance Flag?Delist Request?
Patented Use:EMERGENCY TREATMENT OF ALLERGIC REACTIONS (TYPE I), INCLUDING ANAPHYLAXIS

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