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Last Updated: April 20, 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 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

Medical Subject Heading (MeSH) Categories for 020800

Adrenergic alpha-Agonists
Adrenergic beta-Agonists
Bronchodilator Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents

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:	DISCN	Dosage:	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS			Strength	EQ 0.3MG/DELIVERY
Approval Date:	May 30, 2003	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS			Strength	EQ 0.15MG/DELIVERY
Approval Date:	May 28, 2004	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS			Strength	EQ 0.15MG/DELIVERY
Approval Date:	Nov 25, 2009	TE:	BX	RLD:	Yes

Expired US Patents for NDA 020800

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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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