FDA.reportPublic FDA data

Application 078759

Type
ANDA
Sponsor
CIPLA

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
69097-313GEMCITABINE HYDROCHLORIDEGEMCITABINE HYDROCHLORIDECipla USA Inc.ANDACurrent
69097-313GEMCITABINE HYDROCHLORIDEGEMCITABINE HYDROCHLORIDECipla USA Inc.ANDACurrent
69097-313GEMCITABINE HYDROCHLORIDEGEMCITABINE HYDROCHLORIDECipla USA Inc.ANDACurrent
69097-314GEMCITABINE HYDROCHLORIDEGEMCITABINE HYDROCHLORIDECipla USA Inc.ANDACurrent
69097-314GEMCITABINE HYDROCHLORIDEGEMCITABINE HYDROCHLORIDECipla USA Inc.ANDACurrent
69097-314GEMCITABINE HYDROCHLORIDEGEMCITABINE HYDROCHLORIDECipla USA Inc.ANDACurrent