Application 090589

Type: ANDA
Sponsor: TEVA PHARMS USA

Related Records

Company: TEVA PHARMS USA

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EPINEPHRINE (AUTOINJECTOR)	EPINEPHRINE	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	0.3MG/DELIVERY	No	No
002	EPINEPHRINE (AUTOINJECTOR)	EPINEPHRINE	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	0.15MG/DELIVERY	No	No

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-5985	Epinephrine	Epinephrine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5985	Epinephrine	Epinephrine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5985	Epinephrine	Epinephrine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5985	Epinephrine	Epinephrine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5985	Epinephrine	Epinephrine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5985	Epinephrine	Epinephrine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5985	Epinephrine	Epinephrine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5985	Epinephrine	Epinephrine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5986	Epinephrine	Epinephrine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5986	Epinephrine	Epinephrine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5986	Epinephrine	Epinephrine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5986	Epinephrine	Epinephrine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5986	Epinephrine	Epinephrine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5986	Epinephrine	Epinephrine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5986	Epinephrine	Epinephrine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5986	Epinephrine	Epinephrine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
50090-4544	Epinephrine	Epinephrine	A-S Medication Solutions	ANDA	Current
50090-4544	Epinephrine	Epinephrine	A-S Medication Solutions	ANDA	Current
50090-5254	Epinephrine	Epinephrine	A-S Medication Solutions	ANDA	Current
50090-5254	Epinephrine	Epinephrine	A-S Medication Solutions	ANDA	Current
50090-5254	Epinephrine	Epinephrine	A-S Medication Solutions	ANDA	Current
63629-8801	Epinephrine	Epinephrine	Bryant Ranch Prepack	ANDA	Current
63629-8801	Epinephrine	Epinephrine	Bryant Ranch Prepack	ANDA	Current
63629-8801	Epinephrine	Epinephrine	Bryant Ranch Prepack	ANDA	Current
70518-2283	Epinephrine	Epinephrine	REMEDYREPACK INC.	ANDA	Current
70518-2283	Epinephrine	Epinephrine	REMEDYREPACK INC.	ANDA	Current
70518-2283	Epinephrine	Epinephrine	REMEDYREPACK INC.	ANDA	Current
70518-3173	Epinephrine	Epinephrine	REMEDYREPACK INC.	ANDA	Current
76420-188	Epinephrine	Epinephrine	Asclemed USA, Inc.	ANDA	Current
76420-188	Epinephrine	Epinephrine	Asclemed USA, Inc.	ANDA	Current

Documents

Document	Submission type	Date
71472	ORIG	2022-06-28
55393	ORIG	2018-09-06