FDA.reportPublic FDA data

Application 201570

Type
ANDA
Sponsor
APOTEX INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ABACAVIR SULFATEABACAVIR SULFATETABLET;ORALEQ 300MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-6523Abacavir SulfateAbacavir SulfateMajor PharmaceuticalsANDACurrent
0904-6523Abacavir SulfateAbacavir SulfateMajor PharmaceuticalsANDACurrent
60505-3583Abacavir SulfateAbacavir SulfateApotex CorpANDACurrent
60505-3583Abacavir SulfateAbacavir SulfateApotex CorpANDACurrent
70518-0640Abacavir SulfateAbacavir SulfateREMEDYREPACK INC.ANDACurrent
70518-0640Abacavir SulfateAbacavir SulfateREMEDYREPACK INC.ANDACurrent