Application 020800

Type: NDA
Sponsor: IMPAX

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TWINJECT 0.3	EPINEPHRINE	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	EQ 0.3MG/DELIVERY	No	No
002	TWINJECT 0.15	EPINEPHRINE	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	EQ 0.15MG/DELIVERY	No	No
003	ADRENACLICK	EPINEPHRINE	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	EQ 0.15MG/DELIVERY	Yes	Yes
004	ADRENACLICK	EPINEPHRINE	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	EQ 0.3MG/DELIVERY	Yes	Yes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0115-1694	epinephrine	epinephrine	Impax Generics	NDA AUTHORIZED GENERIC	Current
0115-1694	epinephrine	epinephrine	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
0115-1694	epinephrine	epinephrine	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
0115-1694	epinephrine	epinephrine	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
0115-1695	epinephrine	epinephrine	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
0115-1695	epinephrine	epinephrine	Impax Generics	NDA AUTHORIZED GENERIC	Current
0115-1695	epinephrine	epinephrine	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
0115-1695	epinephrine	epinephrine	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
21695-947	epinephrine	epinephrine	Rebel Distributors Corp	NDA AUTHORIZED GENERIC	Current
42291-425	epinephrine	epinephrine	AvKARE	NDA AUTHORIZED GENERIC	Current
42291-425	epinephrine	epinephrine	AvKARE	NDA AUTHORIZED GENERIC	Current
42291-425	epinephrine	epinephrine	AvKARE	NDA AUTHORIZED GENERIC	Current
42291-425	epinephrine	epinephrine	AvKARE	NDA AUTHORIZED GENERIC	Current
50090-1360	epinephrine	epinephrine	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
50090-3155	epinephrine	epinephrine	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
50090-3155	epinephrine	epinephrine	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
50090-3155	epinephrine	epinephrine	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
50090-4506	epinephrine	epinephrine	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
51662-1222	EPINEPHRINE	EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	NDA AUTHORIZED GENERIC	Current
51662-1222	EPINEPHRINE	EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	NDA AUTHORIZED GENERIC	Current
51662-1222	EPINEPHRINE	EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	NDA AUTHORIZED GENERIC	Current
51662-1222	EPINEPHRINE	EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	NDA AUTHORIZED GENERIC	Current
51662-1223	EPINEPHRINE	EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	NDA AUTHORIZED GENERIC	Current
51662-1223	EPINEPHRINE	EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	NDA AUTHORIZED GENERIC	Current
51662-1223	EPINEPHRINE	EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	NDA AUTHORIZED GENERIC	Current
51662-1223	EPINEPHRINE	EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	NDA AUTHORIZED GENERIC	Current
68788-6376	epinephrine	epinephrine	Preferred Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
70385-2009	epinephrine	epinephrine	Sina Health Inc	NDA AUTHORIZED GENERIC	Current
70385-2017	epinephrine	epinephrine	Sina Health Inc	NDA AUTHORIZED GENERIC	Current
70518-2048	epinephrine	epinephrine	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
70518-2048	epinephrine	epinephrine	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
70518-2048	epinephrine	epinephrine	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
70518-2048	epinephrine	epinephrine	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
71872-7007	epinephrine	epinephrine	Medical Purchasing Solutions, LLC	NDA AUTHORIZED GENERIC	Current
71872-7007	epinephrine	epinephrine	Medical Purchasing Solutions, LLC	NDA AUTHORIZED GENERIC	Current
71872-7103	epinephrine	epinephrine	Medical Purchasing Solutions, LLC	NDA AUTHORIZED GENERIC	Current
71872-7103	epinephrine	epinephrine	Medical Purchasing Solutions, LLC	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85501	SUPPL	2026-03-24
85444	SUPPL	2026-03-23
80264	SUPPL	2024-11-21
80251	SUPPL	2024-11-20
66119	SUPPL	2021-02-08
66113	SUPPL	2021-02-05
55473	SUPPL	2018-09-13
55369	SUPPL	2018-08-30
47090	SUPPL	2017-02-02
13460	SUPPL	2016-05-20
25867	SUPPL	2016-05-19
3391	SUPPL	2014-10-22
35387	SUPPL	2014-10-21
35386	SUPPL	2014-07-29
25866	SUPPL	2014-07-28
13459	SUPPL	2014-04-25
25865	SUPPL	2014-04-24
20967	SUPPL	2013-10-21
25864	SUPPL	2011-02-03
13458	SUPPL	2011-01-31
35385	SUPPL	2009-12-02
25863	SUPPL	2007-01-08
25861	SUPPL	2005-07-15
25862	SUPPL	2005-07-08
41709	ORIG	2005-04-08
3390	SUPPL	2005-02-23
3389	SUPPL	2004-06-01
3388	ORIG	2003-06-08

Application 020800

Related Records#

Application Products#

NDC Listings For This Application#

Documents#