FDA.reportPublic FDA data

Application 079160

Type
ANDA
Sponsor
ACTAVIS TOTOWA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GEMCITABINE HYDROCHLORIDEGEMCITABINE HYDROCHLORIDEINJECTABLE;INJECTIONEQ 200MG BASE/VIALNoNo
002GEMCITABINE HYDROCHLORIDEGEMCITABINE HYDROCHLORIDEINJECTABLE;INJECTIONEQ 1GM BASE/VIALNoNo
003GEMCITABINE HYDROCHLORIDEGEMCITABINE HYDROCHLORIDEINJECTABLE;INJECTIONEQ 2GM BASE/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
45963-612gemcitabine hydrochloridegemcitabine hydrochlorideActavis Pharma, Inc.ANDACurrent
45963-612gemcitabine hydrochloridegemcitabine hydrochlorideActavis Pharma, Inc.ANDACurrent
45963-612gemcitabine hydrochloridegemcitabine hydrochlorideActavis Pharma, Inc.ANDACurrent
45963-612gemcitabine hydrochloridegemcitabine hydrochlorideActavis Pharma, Inc.ANDACurrent
45963-619gemcitabine hydrochloridegemcitabine hydrochlorideActavis Pharma, Inc.ANDACurrent
45963-619gemcitabine hydrochloridegemcitabine hydrochlorideActavis Pharma, Inc.ANDACurrent
45963-619gemcitabine hydrochloridegemcitabine hydrochlorideActavis Pharma, Inc.ANDACurrent
45963-619gemcitabine hydrochloridegemcitabine hydrochlorideActavis Pharma, Inc.ANDACurrent
45963-620gemcitabine hydrochloridegemcitabine hydrochlorideActavis Pharma, Inc.ANDACurrent
45963-620gemcitabine hydrochloridegemcitabine hydrochlorideActavis Pharma, Inc.ANDACurrent
45963-620gemcitabine hydrochloridegemcitabine hydrochlorideActavis Pharma, Inc.ANDACurrent