FDA.reportPublic FDA data

Application 203490

Type
ANDA
Sponsor
AMERIGEN PHARMS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TEMOZOLOMIDETEMOZOLOMIDECAPSULE;ORAL5MGNoNo
002TEMOZOLOMIDETEMOZOLOMIDECAPSULE;ORAL20MGNoNo
003TEMOZOLOMIDETEMOZOLOMIDECAPSULE;ORAL100MGNoNo
004TEMOZOLOMIDETEMOZOLOMIDECAPSULE;ORAL140MGNoNo
005TEMOZOLOMIDETEMOZOLOMIDECAPSULE;ORAL180MGNoNo
006TEMOZOLOMIDETEMOZOLOMIDECAPSULE;ORAL250MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43975-252TemozolomideTemozolomideANI Pharmaceuticals, Inc.ANDACurrent
43975-252TEMOZOLOMIDETEMOZOLOMIDEAmerigen Pharmaceuticals Inc.ANDACurrent
43975-252TEMOZOLOMIDETEMOZOLOMIDEANI Pharmaceuticals, Inc.ANDACurrent
43975-253TEMOZOLOMIDETEMOZOLOMIDEANI Pharmaceuticals, Inc.ANDACurrent
43975-253TemozolomideTemozolomideANI Pharmaceuticals, Inc.ANDACurrent
43975-253TEMOZOLOMIDETEMOZOLOMIDEAmerigen Pharmaceuticals Inc.ANDACurrent
43975-254TEMOZOLOMIDETEMOZOLOMIDEANI Pharmaceuticals, Inc.ANDACurrent
43975-254TemozolomideTemozolomideANI Pharmaceuticals, Inc.ANDACurrent
43975-254TEMOZOLOMIDETEMOZOLOMIDEAmerigen Pharmaceuticals Inc.ANDACurrent
43975-255TemozolomideTemozolomideANI Pharmaceuticals, Inc.ANDACurrent
43975-255TEMOZOLOMIDETEMOZOLOMIDEAmerigen Pharmaceuticals Inc.ANDACurrent
43975-255TEMOZOLOMIDETEMOZOLOMIDEANI Pharmaceuticals, Inc.ANDACurrent
43975-256TEMOZOLOMIDETEMOZOLOMIDEANI Pharmaceuticals, Inc.ANDACurrent
43975-256TemozolomideTemozolomideANI Pharmaceuticals, Inc.ANDACurrent
43975-256TEMOZOLOMIDETEMOZOLOMIDEAmerigen Pharmaceuticals Inc.ANDACurrent
43975-257TEMOZOLOMIDETEMOZOLOMIDEANI Pharmaceuticals, Inc.ANDACurrent
43975-257TemozolomideTemozolomideANI Pharmaceuticals, Inc.ANDACurrent
43975-257TEMOZOLOMIDETEMOZOLOMIDEAmerigen Pharmaceuticals Inc.ANDACurrent
62559-920TemozolomideTemozolomideANI Pharmaceuticals, Inc.ANDACurrent
62559-920TemozolomideTemozolomideANI Pharmaceuticals, Inc.ANDACurrent
62559-920TemozolomideTemozolomideANI Pharmaceuticals, Inc.ANDACurrent
62559-920TemozolomideTemozolomideANI Pharmaceuticals, Inc.ANDACurrent
62559-921TemozolomideTemozolomideANI Pharmaceuticals, Inc.ANDACurrent
62559-921TemozolomideTemozolomideANI Pharmaceuticals, Inc.ANDACurrent
62559-921TemozolomideTemozolomideANI Pharmaceuticals, Inc.ANDACurrent
62559-921TemozolomideTemozolomideANI Pharmaceuticals, Inc.ANDACurrent
62559-922TemozolomideTemozolomideANI Pharmaceuticals, Inc.ANDACurrent
62559-922TemozolomideTemozolomideANI Pharmaceuticals, Inc.ANDACurrent
62559-922TemozolomideTemozolomideANI Pharmaceuticals, Inc.ANDACurrent
62559-922TemozolomideTemozolomideANI Pharmaceuticals, Inc.ANDACurrent
62559-923TemozolomideTemozolomideANI Pharmaceuticals, Inc.ANDACurrent
62559-923TemozolomideTemozolomideANI Pharmaceuticals, Inc.ANDACurrent
62559-923TemozolomideTemozolomideANI Pharmaceuticals, Inc.ANDACurrent
62559-923TemozolomideTemozolomideANI Pharmaceuticals, Inc.ANDACurrent
62559-924TemozolomideTemozolomideANI Pharmaceuticals, Inc.ANDACurrent
62559-924TemozolomideTemozolomideANI Pharmaceuticals, Inc.ANDACurrent
62559-924TemozolomideTemozolomideANI Pharmaceuticals, Inc.ANDACurrent
62559-924TemozolomideTemozolomideANI Pharmaceuticals, Inc.ANDACurrent
62559-925TemozolomideTemozolomideANI Pharmaceuticals, Inc.ANDACurrent
62559-925TemozolomideTemozolomideANI Pharmaceuticals, Inc.ANDACurrent
62559-925TemozolomideTemozolomideANI Pharmaceuticals, Inc.ANDACurrent
62559-925TemozolomideTemozolomideANI Pharmaceuticals, Inc.ANDACurrent