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Details for New Drug Application (NDA): 019430

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NDA 019430 describes EPIPEN JR., which is a drug marketed by Mylan Speclt and is included in one NDA. It is available from five suppliers. There are four patents protecting this drug and one Paragraph IV challenge. Additional details are available on the EPIPEN JR. profile page.

The generic ingredient in EPIPEN JR. is epinephrine. There are nineteen drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the epinephrine profile page.

Summary for NDA: 019430

Tradename:
4
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 019430

Suppliers and Packaging for NDA: 019430

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EPI E Z PEN JR
epinephrine
INJECTABLE;INTRAMUSCULAR 019430 NDA AUTHORIZED GENERIC Mylan Specialty L.P. 49502-101 49502-101-02 2 CONTAINER in 1 CARTON (49502-101-02) > 1 SYRINGE, GLASS in 1 CONTAINER (49502-101-01) > .3 mL in 1 SYRINGE, GLASS
EPI E Z PEN JR
epinephrine
INJECTABLE;INTRAMUSCULAR 019430 NDA AUTHORIZED GENERIC Mylan Specialty L.P. 49502-102 49502-102-02 2 CONTAINER in 1 CARTON (49502-102-02) > 1 SYRINGE, GLASS in 1 CONTAINER (49502-102-01) > .3 mL in 1 SYRINGE, GLASS

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUSStrength0.3MG/DELIVERY
Approval Date:Dec 22, 1987TE:BXRLD:Yes
Patent:7,449,012Patent Expiration:Sep 11, 2025Product Flag?YSubstance Flag?Delist Request?
Patent:7,794,432Patent Expiration:Sep 11, 2025Product Flag?YSubstance Flag?Delist Request?
Patent:8,048,035Patent Expiration:Sep 11, 2025Product Flag?YSubstance Flag?Delist Request?


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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