FDA.reportPublic FDA data

Application 205242

Type
ANDA
Sponsor
MYLAN LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GEMCITABINE HYDROCHLORIDEGEMCITABINE HYDROCHLORIDEINJECTABLE;INJECTION200MG/5.26ML (38MG/ML)NoNo
002GEMCITABINE HYDROCHLORIDEGEMCITABINE HYDROCHLORIDEINJECTABLE;INJECTION1GM/26.3ML (38MG/ML)NoNo
003GEMCITABINE HYDROCHLORIDEGEMCITABINE HYDROCHLORIDEINJECTABLE;INJECTION2GM/52.6ML (38MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
67457-616GemcitabineGEMCITABINE HYDROCHLORIDEMylan Institutional LLCANDACurrent
67457-616GemcitabineGEMCITABINE HYDROCHLORIDEMylan Institutional LLCANDACurrent
67457-617GemcitabineGEMCITABINE HYDROCHLORIDEMylan Institutional LLCANDACurrent
67457-617GemcitabineGEMCITABINE HYDROCHLORIDEMylan Institutional LLCANDACurrent
67457-618GemcitabineGEMCITABINE HYDROCHLORIDEMylan Institutional LLCANDACurrent
67457-618GemcitabineGEMCITABINE HYDROCHLORIDEMylan Institutional LLCANDACurrent