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Generated: November 17, 2018

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Details for New Drug Application (NDA): 204200

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NDA 204200 describes ADRENALIN, which is a drug marketed by Par Sterile Products and is included in two NDAs. It is available from four suppliers. There are two 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 drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the epinephrine profile page.
Summary for 204200
Tradename:ADRENALIN
Applicant:Par Sterile Products
Ingredient:epinephrine
Patents:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 204200
Suppliers and Packaging for NDA: 204200
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ADRENALIN epinephrine SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS 204200 NDA Par Pharmaceutical, Inc. 42023-159 42023-159-25 25 VIAL in 1 CARTON (42023-159-25) > 1 mL in 1 VIAL
ADRENALIN epinephrine SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS 204200 NDA HF Acquisition Co LLC, DBA HealthFirst 51662-1290 51662-1290-1 1 mL in 1 VIAL, SINGLE-DOSE (51662-1290-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAMUSCULAR, SUBCUTANEOUSStrengthEQ 1MG BASE/ML (EQ 1MG BASE/ML)
Approval Date:Dec 7, 2012TE:APRLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Mar 13, 2035Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Try a Free TrialPatent Expiration:Mar 13, 2035Product Flag?Substance Flag?Delist Request?
Patented Use:EMERGENCY TREATMENT OF ALLERGIC REACTIONS (TYPE I), INCLUDING ANAPHYLAXIS

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