FDA.reportPublic FDA data

Application 040784

Type
ANDA
Sponsor
XGEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ACETAZOLAMIDE SODIUMACETAZOLAMIDE SODIUMINJECTABLE;INJECTIONEQ 500MG BASE/VIALNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
39822-0190AcetazolamideAcetazolamideXGen Pharmaceuticals DJB, Inc.ANDACurrent
39822-0190AcetazolamideAcetazolamideX-GEN Pharmaceuticals, Inc.ANDACurrent
39822-0190AcetazolamideAcetazolamideXGen Pharmaceuticals DJB, Inc.ANDACurrent
39822-0190AcetazolamideAcetazolamideX-GEN Pharmaceuticals, Inc.ANDACurrent
39822-0190AcetazolamideAcetazolamideX-GEN Pharmaceuticals, Inc.ANDACurrent
39822-0190AcetazolamideAcetazolamideX-GEN Pharmaceuticals, Inc.ANDACurrent
39822-0191AcetazolamideAcetazolamideX-GEN Pharmaceuticals, Inc.ANDACurrent