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Last Updated: May 19, 2024

Details for New Drug Application (NDA): 020800


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NDA 020800 describes TWINJECT 0.3, which is a drug marketed by Impax and is included in one NDA. It is available from five suppliers. Additional details are available on the TWINJECT 0.3 profile page.

The generic ingredient in TWINJECT 0.3 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 020800
Tradename:TWINJECT 0.3
Applicant:Impax
Ingredient:epinephrine
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 020800
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ADRENACLICK epinephrine INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS 020800 NDA AUTHORIZED GENERIC Amneal Pharmaceuticals of New York LLC 0115-1694 0115-1694-30 1 CASE in 1 CARTON (0115-1694-30) / 1 SYRINGE, GLASS in 1 CASE / .3 mL in 1 SYRINGE, GLASS
ADRENACLICK epinephrine INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS 020800 NDA AUTHORIZED GENERIC Amneal Pharmaceuticals of New York LLC 0115-1694 0115-1694-49 2 CASE in 1 CARTON (0115-1694-49) / 1 SYRINGE, GLASS in 1 CASE / .3 mL in 1 SYRINGE, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUSStrengthEQ 0.3MG/DELIVERY
Approval Date:May 30, 2003TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUSStrengthEQ 0.15MG/DELIVERY
Approval Date:May 28, 2004TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUSStrengthEQ 0.15MG/DELIVERY
Approval Date:Nov 25, 2009TE:BXRLD:Yes

Expired US Patents for NDA 020800

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Impax ADRENACLICK epinephrine INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS 020800-003 Nov 25, 2009 ⤷  Try a Trial ⤷  Try a Trial
Impax ADRENACLICK epinephrine INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS 020800-004 Nov 25, 2009 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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