FDA.reportPublic FDA data

Application 209717

Type
ANDA
Sponsor
AMNEAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ATAZANAVIR SULFATEATAZANAVIR SULFATECAPSULE;ORALEQ 100MG BASENoNo
002ATAZANAVIR SULFATEATAZANAVIR SULFATECAPSULE;ORALEQ 150MG BASENoNo
003ATAZANAVIR SULFATEATAZANAVIR SULFATECAPSULE;ORALEQ 200MG BASENoNo
004ATAZANAVIR SULFATEATAZANAVIR SULFATECAPSULE;ORALEQ 300MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
69238-1135AtazanavirAtazanavirAmneal Pharmaceuticals NY LLCANDACurrent
69238-1135AtazanavirAtazanavirAmneal Pharmaceuticals NY LLCANDACurrent
69238-1135AtazanavirAtazanavirAmneal Pharmaceuticals NY LLCANDACurrent
69238-1136AtazanavirAtazanavirAmneal Pharmaceuticals NY LLCANDACurrent
69238-1136AtazanavirAtazanavirAmneal Pharmaceuticals NY LLCANDACurrent
69238-1136AtazanavirAtazanavirAmneal Pharmaceuticals NY LLCANDACurrent
69238-1137AtazanavirAtazanavirAmneal Pharmaceuticals NY LLCANDACurrent
69238-1137AtazanavirAtazanavirAmneal Pharmaceuticals NY LLCANDACurrent
69238-1137AtazanavirAtazanavirAmneal Pharmaceuticals NY LLCANDACurrent
69238-1138AtazanavirAtazanavirAmneal Pharmaceuticals NY LLCANDACurrent
69238-1138AtazanavirAtazanavirAmneal Pharmaceuticals NY LLCANDACurrent
69238-1138AtazanavirAtazanavirAmneal Pharmaceuticals NY LLCANDACurrent