Application 040424

Type: ANDA
Sponsor: MYLAN

Related Records

Company: MYLAN

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SPIRONOLACTONE	SPIRONOLACTONE	TABLET;ORAL	25MG	No	No
002	SPIRONOLACTONE	SPIRONOLACTONE	TABLET;ORAL	50MG	No	No
003	SPIRONOLACTONE	SPIRONOLACTONE	TABLET;ORAL	100MG	No	No

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-0243	Spironolactone	spironolactone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0243	Spironolactone	spironolactone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0243	Spironolactone	spironolactone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0243	Spironolactone	spironolactone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0243	Spironolactone	spironolactone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0437	Spironolactone	spironolactone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0437	Spironolactone	spironolactone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0437	Spironolactone	spironolactone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0437	Spironolactone	spironolactone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0437	Spironolactone	spironolactone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2146	Spironolactone	spironolactone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2146	Spironolactone	spironolactone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2146	Spironolactone	spironolactone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2146	Spironolactone	spironolactone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2146	Spironolactone	spironolactone	Mylan Pharmaceuticals Inc.	ANDA	Current
0615-1535	Spironolactone	spironolactone	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-5592	Spironolactone	spironolactone	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-6591	Spironolactone	spironolactone	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
51079-103	Spironolactone	spironolactone	Mylan Institutional Inc.	ANDA	Current
51079-103	Spironolactone	spironolactone	Mylan Institutional Inc.	ANDA	Current
51079-103	Spironolactone	spironolactone	Mylan Institutional Inc.	ANDA	Current
51079-979	Spironolactone	spironolactone	Mylan Institutional Inc.	ANDA	Current
51079-979	Spironolactone	spironolactone	Mylan Institutional Inc.	ANDA	Current
51079-979	Spironolactone	spironolactone	Mylan Institutional Inc.	ANDA	Current
51079-980	Spironolactone	spironolactone	Mylan Institutional Inc.	ANDA	Current
51079-980	Spironolactone	spironolactone	Mylan Institutional Inc.	ANDA	Current
51079-980	Spironolactone	spironolactone	Mylan Institutional Inc.	ANDA	Current
55154-5055	Spironolactone	spironolactone	Cardinal Health	ANDA	Current
55154-5055	Spironolactone	spironolactone	Cardinal Health	ANDA	Current
55154-5517	Spironolactone	spironolactone	Cardinal Health	ANDA	Current
55154-5517	Spironolactone	spironolactone	Cardinal Health	ANDA	Current
55154-5517	Spironolactone	spironolactone	Cardinal Health 107, LLC	ANDA	Current
55154-5517	Spironolactone	spironolactone	Cardinal Health	ANDA	Current
67544-310	Spironolactone	spironolactone	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
67544-310	Spironolactone	spironolactone	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
67544-310	Spironolactone	spironolactone	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current

Documents

Document	Submission type	Date
38896	ORIG	2004-06-18
22139	ORIG	2003-07-31
7658	ORIG	2003-04-10