FDA.reportPublic FDA data

Application 210588

Type
ANDA
Sponsor
NOVITIUM PHARMA

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
10135-772AcetazolamideAcetazolamideMarlex Pharmaceuticals, Inc.ANDACurrent
10135-773AcetazolamideAcetazolamideMarlex Pharmaceuticals, Inc.ANDACurrent
70954-033AcetazolamideAcetazolamideNovitium Pharma LLCANDACurrent
70954-033AcetazolamideAcetazolamideNovitium Pharma LLCANDACurrent
70954-033AcetazolamideAcetazolamideNovitium Pharma LLCANDACurrent
70954-034AcetazolamideAcetazolamideNovitium Pharma LLCANDACurrent
70954-034AcetazolamideAcetazolamideNovitium Pharma LLCANDACurrent
70954-034AcetazolamideAcetazolamideNovitium Pharma LLCANDACurrent