FDA.reportPublic FDA data

Application 205356

Type
ANDA
Sponsor
XELLIA PHARMS APS

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
39822-0617Colistimethatecolistimethate sodiumX-GEN Pharmaceuticals, Inc.ANDACurrent
45932-0023Colistimethatecolistimethate sodiumXellia Pharmaceuticals ApSANDACurrent
70594-023ColistimethateColistimethate SodiumXellia Pharmaceuticals USA LLCANDACurrent
70594-023ColistimethateColistimethate SodiumXellia Pharmaceuticals USA LLCANDACurrent
70594-023ColistimethateColistimethate SodiumXellia Pharmaceuticals USA LLCANDACurrent
70594-023Colistimethatecolistimethate sodiumXellia Pharmaceuticals USA LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
10438ORIG2015-06-02