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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. Additional details are available on the ADRENALIN profile page.

The generic ingredient in ADRENALIN is epinephrine. There are seventeen drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the epinephrine profile page.

Summary for NDA: 204200

Tradename:
ADRENALIN
Applicant:
Par Sterile Products
Ingredient:
epinephrine
Patents:2
Therapeutic Class:Respiratory Tract Agents
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
INJECTABLE;INTRAMUSCULAR, INTRAOCULAR, SUBCUTANEOUS 204200 NDA Focus Health Group 24357-911 24357-911-01 1 mL in 1 KIT (24357-911-01)
ADRENALIN
epinephrine
INJECTABLE;INTRAMUSCULAR, INTRAOCULAR, SUBCUTANEOUS 204200 NDA Par Pharmaceutical, Inc. 42023-159 42023-159-25 25 VIAL in 1 CARTON (42023-159-25) > 1 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAMUSCULAR, INTRAOCULAR, SUBCUTANEOUSStrengthEQ 1MG BASE/ML (EQ 1MG BASE/ML)
Approval Date:Dec 7, 2012TE:RLD:Yes
Patent:9,119,876Patent Expiration:Mar 13, 2035Product Flag?YSubstance Flag?Delist Request?
Patent:9,295,657Patent Expiration:Mar 13, 2035Product Flag?Substance Flag?Delist Request?
Patented Use:EMERGENCY TREATMENT OF ALLERGIC REACTIONS (TYPE I), INCLUDING ANAPHYLAXIS
Patent:9,295,657Patent Expiration:Mar 13, 2035Product Flag?Substance Flag?Delist Request?
Patented Use:INDUCTION AND MAINTENANCE OF MYDRIASIS DURING INTRAOCULAR SURGERY


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