FDA.reportPublic FDA data

Application 211012

Type
ANDA
Sponsor
AJANTA PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATECAPSULE;ORALEQ 50MG BASENoNo
002DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATECAPSULE;ORALEQ 100MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
27241-140Doxycycline HyclateDoxycycline HyclateAjanta Pharma USA Inc.ANDACurrent
27241-140Doxycycline HyclateDoxycycline HyclateAjanta Pharma LimitedANDACurrent
27241-140Doxycycline HyclateDoxycycline HyclateAjanta Pharma LimitedANDACurrent
27241-141Doxycycline HyclateDoxycycline HyclateAjanta Pharma USA Inc.ANDACurrent
27241-141Doxycycline HyclateDoxycycline HyclateAjanta Pharma LimitedANDACurrent
27241-141Doxycycline HyclateDoxycycline HyclateAjanta Pharma LimitedANDACurrent