FDA.reportPublic FDA data

Application 202063

Type
ANDA
Sponsor
EMCURE PHARMS 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
23155-213Gemcitabine hydrochlorideGemcitabine hydrochlorideHeritage Pharmaceuticals Inc.ANDACurrent
23155-213Gemcitabine hydrochlorideGemcitabine hydrochlorideHeritage Pharmaceuticals Inc.ANDACurrent
23155-214Gemcitabine hydrochlorideGemcitabine hydrochlorideHeritage Pharmaceuticals Inc.ANDACurrent
23155-214Gemcitabine hydrochlorideGemcitabine hydrochlorideHeritage Pharmaceuticals Inc.ANDACurrent
23155-483Gemcitabine hydrochlorideGemcitabine hydrochlorideHeritage Pharmaceuticals Inc.ANDACurrent
23155-484Gemcitabine hydrochlorideGemcitabine hydrochlorideHeritage Pharmaceuticals Inc.ANDACurrent
23155-528Gemcitabine hydrochlorideGemcitabine hydrochlorideHeritage Pharmaceuticals Inc.ANDACurrent
23155-529Gemcitabine hydrochlorideGemcitabine hydrochlorideHeritage Pharmaceuticals Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
43380ORIG2013-01-22