Application 202359

Type
ANDA
Sponsor
EMCURE PHARMS LTD

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
23155-193COLISTIMETHATE SODIUMCOLISTIMETHATE SODIUMHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-193COLISTIMETHATE SODIUMCOLISTIMETHATE SODIUMHeritage Pharmaceuticals Inc.ANDACurrent
23155-193COLISTIMETHATE SODIUMCOLISTIMETHATE SODIUMHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-193COLISTIMETHATE SODIUMCOLISTIMETHATE SODIUMHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent