Application 075138

Type: ANDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	120MG	No	No
002	VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	180MG	No	No
003	VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	240MG	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-6320	Verapamil Hydrochloride	verapamil hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6320	Verapamil Hydrochloride	verapamil hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6320	Verapamil Hydrochloride	verapamil hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6320	Verapamil Hydrochloride	verapamil hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6380	Verapamil Hydrochloride	verapamil hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6380	Verapamil Hydrochloride	verapamil hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6380	Verapamil Hydrochloride	verapamil hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6380	Verapamil Hydrochloride	verapamil hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6440	Verapamil Hydrochloride	verapamil hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6440	Verapamil Hydrochloride	verapamil hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6440	Verapamil Hydrochloride	verapamil hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6440	Verapamil Hydrochloride	verapamil hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
51079-917	Verapamil Hydrochloride	verapamil hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-917	Verapamil Hydrochloride	verapamil hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-917	Verapamil Hydrochloride	verapamil hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-917	Verapamil Hydrochloride	verapamil hydrochloride	Mylan Institutional Inc.	ANDA	Current
63629-7845	Verapamil Hydrochloride	verapamil hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-7845	Verapamil Hydrochloride	verapamil hydrochloride	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
39457	ORIG	2004-06-29
42944	ORIG	1999-04-20
8535	ORIG	1999-04-20