FDA.reportPublic FDA data

Application 064216

Type
ANDA
Sponsor
XGEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001COLISTIMETHATE SODIUMCOLISTIMETHATE SODIUMINJECTABLE;INJECTIONEQ 150MG BASE/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
39822-0615ColistimethateColistimethateX-GEN Pharmaceuticals, Inc.ANDACurrent
39822-0615ColistimethateColistimethateXGen Pharmaceuticals DJB, Inc.ANDACurrent
39822-0615ColistimethateColistimethateX-GEN Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22300ORIG2012-06-27
23732ORIG2007-06-29
8360ORIG1999-02-26