FDA.reportPublic FDA data

Application 078564

Type
ANDA
Sponsor
WOCKHARDT USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GRANISETRON HYDROCHLORIDEGRANISETRON HYDROCHLORIDEINJECTABLE;INJECTIONEQ 1MG BASE/ML (EQ 1MG BASE/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55648-661GRANISETRON HYDROCHLORIDEGRANISETRON HYDROCHLORIDEWOCKHARDT LIMITEDANDACurrent
64679-661GRANISETRON HYDROCHLORIDEGRANISETRON HYDROCHLORIDEWockhardt USA LLC.ANDACurrent
64679-661GRANISETRON HYDROCHLORIDEGRANISETRON HYDROCHLORIDEWockhardt USA LLC.ANDACurrent
64679-661GRANISETRON HYDROCHLORIDEGRANISETRON HYDROCHLORIDEWockhardt USA LLC.ANDACurrent