Application 077746

Type: ANDA
Sponsor: APOTEX

Related Records

Company: APOTEX

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	TABLET;ORAL	2.5MG	No	No
002	MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	TABLET;ORAL	5MG	No	No
003	MIDODRINE HYDROCHLORIDE	MIDODRINE HYDROCHLORIDE	TABLET;ORAL	10MG	No	No

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-8291	Midodrine Hydrochloride	Midodrine Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8291	Midodrine Hydrochloride	Midodrine Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8291	Midodrine Hydrochloride	Midodrine Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8293	Midodrine Hydrochloride	Midodrine Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8293	Midodrine Hydrochloride	Midodrine Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8293	Midodrine Hydrochloride	Midodrine Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8358	midodrine hydrochloride	midodrine	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8358	midodrine hydrochloride	midodrine	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0904-6817	Midodrine Hydrochloride	Midodrine Hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-6817	Midodrine Hydrochloride	Midodrine Hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-6817	Midodrine Hydrochloride	Midodrine Hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-6817	Midodrine Hydrochloride	Midodrine Hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-6817	Midodrine Hydrochloride	Midodrine Hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-6818	Midodrine Hydrochloride	Midodrine Hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-6818	Midodrine Hydrochloride	Midodrine Hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-6818	Midodrine Hydrochloride	Midodrine Hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-6818	Midodrine Hydrochloride	Midodrine Hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-6818	Midodrine Hydrochloride	Midodrine Hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-6819	Midodrine Hydrochloride	Midodrine Hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-6819	Midodrine Hydrochloride	Midodrine Hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-6819	Midodrine Hydrochloride	Midodrine Hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-6819	Midodrine Hydrochloride	Midodrine Hydrochloride	Major Pharmaceuticals	ANDA	Current
42291-560	Midodrine Hydrochloride	Midodrine Hydrochloride	AvKARE, Inc.	ANDA	Current
42291-560	Midodrine Hydrochloride	Midodrine Hydrochloride	AvKARE	ANDA	Current
42291-561	Midodrine Hydrochloride	Midodrine Hydrochloride	AvKARE, Inc.	ANDA	Current
42291-561	Midodrine Hydrochloride	Midodrine Hydrochloride	AvKARE	ANDA	Current
42291-562	Midodrine Hydrochloride	Midodrine Hydrochloride	AvKARE, Inc.	ANDA	Current
42291-562	Midodrine Hydrochloride	Midodrine Hydrochloride	AvKARE	ANDA	Current
50268-561	Midodrine Hydrochloride	Midodrine Hydrochloride	AvPAK	ANDA	Current
50268-561	Midodrine Hydrochloride	Midodrine Hydrochloride	AvPAK	ANDA	Current
50268-562	Midodrine Hydrochloride	Midodrine Hydrochloride	AvPAK	ANDA	Current
50268-562	Midodrine Hydrochloride	Midodrine Hydrochloride	AvPAK	ANDA	Current
50268-563	Midodrine Hydrochloride	Midodrine Hydrochloride	AvPAK	ANDA	Current
50268-563	Midodrine Hydrochloride	Midodrine Hydrochloride	AvPAK	ANDA	Current
55154-8086	Midodrine Hydrochloride	Midodrine Hydrochloride	Cardinal Health	ANDA	Current
55154-8086	Midodrine Hydrochloride	Midodrine Hydrochloride	Cardinal Health 107, LLC	ANDA	Current
60505-1320	Midodrine Hydrochloride	Midodrine Hydrochloride	Apotex Corp	ANDA	Current
60505-1321	Midodrine Hydrochloride	Midodrine Hydrochloride	Apotex Corp	ANDA	Current
60505-1325	Midodrine Hydrochloride	Midodrine Hydrochloride	Apotex Corp	ANDA	Current
60687-387	Midodrine Hydrochloride	Midodrine Hydrochloride	American Health Packaging	ANDA	Current
60687-387	Midodrine Hydrochloride	Midodrine Hydrochloride	American Health Packaging	ANDA	Current
60687-387	Midodrine Hydrochloride	Midodrine Hydrochloride	American Health Packaging	ANDA	Current
60687-398	Midodrine Hydrochloride	Midodrine Hydrochloride	American Health Packaging	ANDA	Current
60687-398	Midodrine Hydrochloride	Midodrine Hydrochloride	American Health Packaging	ANDA	Current
60687-398	Midodrine Hydrochloride	Midodrine Hydrochloride	American Health Packaging	ANDA	Current
60687-409	Midodrine Hydrochloride	Midodrine Hydrochloride	American Health Packaging	ANDA	Current
60687-409	Midodrine Hydrochloride	Midodrine Hydrochloride	American Health Packaging	ANDA	Current
60687-409	Midodrine Hydrochloride	Midodrine Hydrochloride	American Health Packaging	ANDA	Current
71335-1433	Midodrine Hydrochloride	Midodrine Hydrochloride	Bryant Ranch Prepack	ANDA	Current