FDA.reportPublic FDA data

Application 204520

Type
ANDA
Sponsor
GLAND PHARMA LTD

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
68083-148gemcitabine hydrochloridegemcitabine hydrochlorideGland Pharma LimitedANDACurrent
68083-148gemcitabine hydrochloridegemcitabine hydrochlorideGland Pharma LimitedANDACurrent
68083-148gemcitabine hydrochloridegemcitabine hydrochlorideGland Pharma LimitedANDACurrent
68083-148gemcitabine hydrochloridegemcitabine hydrochlorideGland Pharma LimitedANDACurrent
68083-149gemcitabine hydrochloridegemcitabine hydrochlorideGland Pharma LimitedANDACurrent
68083-149gemcitabine hydrochloridegemcitabine hydrochlorideGland Pharma LimitedANDACurrent
68083-149gemcitabine hydrochloridegemcitabine hydrochlorideGland Pharma LimitedANDACurrent
68083-149gemcitabine hydrochloridegemcitabine hydrochlorideGland Pharma LimitedANDACurrent
70860-204Gemcitabinegemcitabine hydrochlorideAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-204Gemcitabinegemcitabine hydrochlorideAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-204Gemcitabinegemcitabine hydrochlorideAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-205Gemcitabinegemcitabine hydrochlorideAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-205Gemcitabinegemcitabine hydrochlorideAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-205Gemcitabinegemcitabine hydrochlorideAthenex Pharmaceutical Division, LLC.ANDACurrent