FDA.reportPublic FDA data

Application 209243

Type
ANDA
Sponsor
APOTEX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATETABLET;ORALEQ 75MG BASENoNo
002DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATETABLET;ORALEQ 150MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60505-4382Doxycycline HyclateDoxycycline HyclateApotex Corp.ANDACurrent
60505-4382Doxycycline HyclateDoxycycline HyclateApotex Corp.ANDACurrent
60505-4384Doxycycline HyclateDoxycycline HyclateApotex Corp.ANDACurrent
60505-4384Doxycycline HyclateDoxycycline HyclateApotex Corp.ANDACurrent