FDA.reportPublic FDA data

Application 209193

Type
ANDA
Sponsor
DEXCEL PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 150MG BASENoNo
002VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 225MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0527-2604Venlafaxine HydrochlorideVenlafaxine HydrochlorideLannett Company, Inc.ANDACurrent
0527-2604Venlafaxine HydrochlorideVenlafaxine HydrochlorideLannett Company, Inc.ANDACurrent
0527-2604Venlafaxine HydrochlorideVenlafaxine HydrochlorideLannett Company, Inc.ANDACurrent
0527-2605Venlafaxine HydrochlorideVenlafaxine HydrochlorideLannett Company, Inc.ANDACurrent
0527-2605Venlafaxine HydrochlorideVenlafaxine HydrochlorideLannett Company, Inc.ANDACurrent
0527-2605Venlafaxine HydrochlorideVenlafaxine HydrochlorideLannett Company, Inc.ANDACurrent
63629-2100Venlafaxine HydrochlorideVenlafaxine HydrochlorideBryant Ranch PrepackANDACurrent
63629-2100Venlafaxine HydrochlorideVenlafaxine HydrochlorideBryant Ranch PrepackANDACurrent
63629-2100Venlafaxine HydrochlorideVenlafaxine HydrochlorideBryant Ranch PrepackANDACurrent
63629-2101Venlafaxine HydrochlorideVenlafaxine HydrochlorideBryant Ranch PrepackANDACurrent
63629-2101Venlafaxine HydrochlorideVenlafaxine HydrochlorideBryant Ranch PrepackANDACurrent
63629-2101Venlafaxine HydrochlorideVenlafaxine HydrochlorideBryant Ranch PrepackANDACurrent
63629-9284Venlafaxine HydrochlorideVenlafaxine HydrochlorideBryant Ranch PrepackANDACurrent