FDA.reportPublic FDA data

Application 201951

Type
ANDA
Sponsor
ACTAVIS ELIZABETH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDETABLET;ORALEQ 3MG BASENoNo
002DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDETABLET;ORALEQ 6MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0228-3315DoxepinDoxepinActavis Pharma, Inc.ANDACurrent
0228-3315DoxepinDoxepinActavis Pharma, Inc.ANDACurrent
0228-3315DoxepinDoxepinActavis Pharma, Inc.ANDACurrent
0228-3316DoxepinDoxepinActavis Pharma, Inc.ANDACurrent
0228-3316DoxepinDoxepinActavis Pharma, Inc.ANDACurrent
0228-3316DoxepinDoxepinActavis Pharma, Inc.ANDACurrent
70518-3495DoxepinDoxepinREMEDYREPACK INC.ANDACurrent