FDA.reportPublic FDA data

Application 065013

Type
ANDA
Sponsor
XGEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TOBRAMYCIN SULFATETOBRAMYCIN SULFATEINJECTABLE;INJECTIONEQ 1.2GM BASE/VIALNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
39822-0409TobramycinTobramycinX-GEN Pharmaceuticals, Inc.ANDACurrent
39822-0412TobramycinTobramycinX-GEN Pharmaceuticals, Inc.ANDACurrent
39822-0412TobramycinTobramycinXGen Pharmaceuticals DJB, Inc.ANDACurrent
39822-0412TobramycinTobramycinXGen Pharmaceuticals DJB, Inc.ANDACurrent
39822-0412TobramycinTobramycinXGen Pharmaceuticals DJB, Inc.ANDACurrent
39822-0412TobramycinTobramycinX-GEN Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
18323SUPPL2012-07-30