FDA.reportPublic FDA data

Application 019614

Type
NDA
Sponsor
RECRO GAINESVILLE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VERELANVERAPAMIL HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL120MGYesNo
002VERELANVERAPAMIL HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL240MGYesNo
003VERELANVERAPAMIL HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL180MGYesNo
004VERELANVERAPAMIL HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL360MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0591-2880Verapamil Hydrochlorideverapamil hydrochlorideActavis Pharma, Inc.NDACurrent
0591-2880Verapamil Hydrochlorideverapamil hydrochlorideTeva Pharmaceuticals IncNDACurrent
0591-2880Verapamil Hydrochlorideverapamil hydrochlorideActavis Pharma, Inc.NDACurrent
0591-2880Verapamil Hydrochlorideverapamil hydrochlorideActavis Pharma, Inc.NDACurrent
0591-2882Verapamil Hydrochlorideverapamil hydrochlorideTeva Pharmaceuticals IncNDACurrent
0591-2882Verapamil Hydrochlorideverapamil hydrochlorideActavis Pharma, Inc.NDACurrent
0591-2882Verapamil Hydrochlorideverapamil hydrochlorideActavis Pharma, Inc.NDACurrent
0591-2882Verapamil Hydrochlorideverapamil hydrochlorideActavis Pharma, Inc.NDACurrent
0591-2884Verapamil Hydrochlorideverapamil hydrochlorideTeva Pharmaceuticals IncNDACurrent
0591-2884Verapamil Hydrochlorideverapamil hydrochlorideActavis Pharma, Inc.NDACurrent
0591-2884Verapamil Hydrochlorideverapamil hydrochlorideActavis Pharma, Inc.NDACurrent
0591-2884Verapamil Hydrochlorideverapamil hydrochlorideActavis Pharma, Inc.NDACurrent
0591-2886Verapamil Hydrochlorideverapamil hydrochlorideTeva Pharmaceuticals IncNDACurrent
0591-2886Verapamil Hydrochlorideverapamil hydrochlorideActavis Pharma, Inc.NDACurrent
0591-2886Verapamil Hydrochlorideverapamil hydrochlorideActavis Pharma, Inc.NDACurrent
0591-2886Verapamil Hydrochlorideverapamil hydrochlorideActavis Pharma, Inc.NDACurrent
62175-580VERELANverapamil hydrochlorideKremers Urban Pharmaceuticals Inc.NDACurrent
62175-580VERELANverapamil hydrochlorideLannett Company, Inc.NDACurrent
62175-580VERELANverapamil hydrochlorideLannett Company, Inc.NDACurrent
62175-580VERELANverapamil hydrochlorideLannett Company, Inc.NDACurrent
62175-581VERELANverapamil hydrochlorideLannett Company, Inc.NDACurrent
62175-581VERELANverapamil hydrochlorideLannett Company, Inc.NDACurrent
62175-581VERELANverapamil hydrochlorideLannett Company, Inc.NDACurrent
62175-581VERELANverapamil hydrochlorideKremers Urban Pharmaceuticals Inc.NDACurrent
62175-582VERELANverapamil hydrochlorideKremers Urban Pharmaceuticals Inc.NDACurrent
62175-582VERELANverapamil hydrochlorideLannett Company, Inc.NDACurrent
62175-582VERELANverapamil hydrochlorideLannett Company, Inc.NDACurrent
62175-582VERELANverapamil hydrochlorideLannett Company, Inc.NDACurrent
62175-583VERELANverapamil hydrochlorideLannett Company, Inc.NDACurrent
62175-583VERELANverapamil hydrochlorideLannett Company, Inc.NDACurrent
62175-583VERELANverapamil hydrochlorideLannett Company, Inc.NDACurrent
62175-583VERELANverapamil hydrochlorideKremers Urban Pharmaceuticals Inc.NDACurrent
63629-4353Verapamil Hydrochlorideverapamil hydrochlorideBryant Ranch PrepackNDACurrent
63629-8842Verapamil Hydrochlorideverapamil hydrochlorideBryant Ranch PrepackNDACurrent
63629-8842Verapamil Hydrochlorideverapamil hydrochlorideBryant Ranch PrepackNDACurrent
68151-0136Verapamil Hydrochlorideverapamil hydrochlorideCarilion Materials ManagementNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
60199SUPPL2019-10-02
60191SUPPL2019-10-02
45913SUPPL2016-11-22
45941SUPPL2016-11-21
11562SUPPL2014-10-15
1417SUPPL2014-10-10
17481SUPPL2011-11-16
11561SUPPL2011-11-14
1416SUPPL2010-04-09
33812SUPPL2010-04-04
17480SUPPL2010-04-02