FDA.reportPublic FDA data

Application 020943

Type
NDA
Sponsor
RECRO GAINESVILLE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VERELAN PMVERAPAMIL HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL100MGYesNo
002VERELAN PMVERAPAMIL HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL200MGYesNo
003VERELAN PMVERAPAMIL HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL300MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
62175-485Verapamil HydrochlorideVerapamil HydrochlorideLannett Company, Inc.NDACurrent
62175-485Verapamil HydrochlorideVerapamil HydrochlorideLannett Company, Inc.NDACurrent
62175-485Verapamil HydrochlorideVerapamil HydrochlorideLannett Company, Inc.NDACurrent
62175-485Verapamil HydrochlorideVerapamil HydrochlorideKremers Urban Pharmaceuticals Inc.NDACurrent
62175-485Verapamil HydrochlorideVerapamil HydrochlorideLannett Company, Inc.NDACurrent
62175-486Verapamil HydrochlorideVerapamil HydrochlorideKremers Urban Pharmaceuticals Inc.NDACurrent
62175-486Verapamil HydrochlorideVerapamil HydrochlorideLannett Company, Inc.NDACurrent
62175-486Verapamil HydrochlorideVerapamil HydrochlorideLannett Company, Inc.NDACurrent
62175-486Verapamil HydrochlorideVerapamil HydrochlorideLannett Company, Inc.NDACurrent
62175-486Verapamil HydrochlorideVerapamil HydrochlorideLannett Company, Inc.NDACurrent
62175-487Verapamil HydrochlorideVerapamil HydrochlorideLannett Company, Inc.NDACurrent
62175-487Verapamil HydrochlorideVerapamil HydrochlorideLannett Company, Inc.NDACurrent
62175-487Verapamil HydrochlorideVerapamil HydrochlorideLannett Company, Inc.NDACurrent
62175-487Verapamil HydrochlorideVerapamil HydrochlorideLannett Company, Inc.NDACurrent
62175-487Verapamil HydrochlorideVerapamil HydrochlorideKremers Urban Pharmaceuticals Inc.NDACurrent
62175-570VERELAN PMverapamil hydrochlorideKremers Urban Pharmaceuticals Inc.NDACurrent
62175-570VERELAN PMverapamil hydrochlorideLannett Company, Inc.NDACurrent
62175-570VERELAN PMverapamil hydrochlorideLannett Company, Inc.NDACurrent
62175-570VERELAN PMverapamil hydrochlorideLannett Company, Inc.NDACurrent
62175-570VERELAN PMverapamil hydrochlorideLannett Company, Inc.NDACurrent
62175-571VERELAN PMverapamil hydrochlorideLannett Company, Inc.NDACurrent
62175-571VERELAN PMverapamil hydrochlorideKremers Urban Pharmaceuticals Inc.NDACurrent
62175-571VERELAN PMverapamil hydrochlorideLannett Company, Inc.NDACurrent
62175-571VERELAN PMverapamil hydrochlorideLannett Company, Inc.NDACurrent
62175-571VERELAN PMverapamil hydrochlorideLannett Company, Inc.NDACurrent
62175-572VERELAN PMverapamil hydrochlorideLannett Company, Inc.NDACurrent
62175-572VERELAN PMverapamil hydrochlorideKremers Urban Pharmaceuticals Inc.NDACurrent
62175-572VERELAN PMverapamil hydrochlorideLannett Company, Inc.NDACurrent
62175-572VERELAN PMverapamil hydrochlorideLannett Company, Inc.NDACurrent
62175-572VERELAN PMverapamil hydrochlorideLannett Company, Inc.NDACurrent
63629-7233Verapamil HydrochlorideVerapamil HydrochlorideBryant Ranch PrepackNDACurrent
63629-7233Verapamil HydrochlorideVerapamil HydrochlorideBryant Ranch PrepackNDACurrent
63629-8017Verapamil HydrochlorideVerapamil HydrochlorideBryant Ranch PrepackNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
60230SUPPL2019-10-04
60225SUPPL2019-10-04
45916SUPPL2016-11-22
45938SUPPL2016-11-21
35690SUPPL2014-10-15
3817SUPPL2014-10-14
26264SUPPL2011-11-16
13792SUPPL2011-11-14
35688SUPPL2010-04-30
3815SUPPL2010-04-09
26263SUPPL2010-04-05
35689SUPPL2010-04-04
26262SUPPL2009-12-24
13791SUPPL2009-12-17
3816SUPPL2007-05-07
26261SUPPL2004-05-07
13790SUPPL2004-05-07
35687ORIG1998-11-25
26260ORIG1998-11-25
21294ORIG1998-11-25