FDA.reportPublic FDA data

Application 078096

Type
ANDA
Sponsor
FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GRANISETRON HYDROCHLORIDE PRESERVATIVE FREEGRANISETRON HYDROCHLORIDEINJECTABLE;INJECTIONEQ 1MG BASE/ML (EQ 1MG BASE/ML)NoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63323-318GranisetronGRANISETRON HYDROCHLORIDEFresenius Kabi USA, LLCANDACurrent
63323-318GranisetronGRANISETRON HYDROCHLORIDEFresenius Kabi USA, LLCANDACurrent
63323-318GranisetronGRANISETRON HYDROCHLORIDEFresenius Kabi USA, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31330SUPPL2014-09-24
18474SUPPL2014-09-23