FDA.reportPublic FDA data

Application 211372

Type
ANDA
Sponsor
APPCO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ACETAZOLAMIDEACETAZOLAMIDETABLET;ORAL125MGNoNo
002ACETAZOLAMIDEACETAZOLAMIDETABLET;ORAL250MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
52817-200ACETAZOLAMIDEACETAZOLAMIDETRUPHARMA, LLCANDACurrent
52817-200ACETAZOLAMIDEACETAZOLAMIDETRUPHARMA, LLCANDACurrent
52817-200ACETAZOLAMIDEACETAZOLAMIDETRUPHARMA, LLCANDACurrent
52817-201ACETAZOLAMIDEACETAZOLAMIDETRUPHARMA, LLCANDACurrent
52817-201ACETAZOLAMIDEACETAZOLAMIDETRUPHARMA, LLCANDACurrent
52817-201ACETAZOLAMIDEACETAZOLAMIDETRUPHARMA, LLCANDACurrent