FDA.reportPublic FDA data

Application 209640

Type
ANDA
Sponsor
AMNEAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DOCETAXELDOCETAXELINJECTABLE;INJECTION20MG/ML (20MG/ML)NoNo
002DOCETAXELDOCETAXELINJECTABLE;INJECTION80MG/4ML (20MG/ML)NoNo
003DOCETAXELDOCETAXELINJECTABLE;INJECTION160MG/8ML (20MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70121-1221DocetaxelDocetaxelAmneal Pharmaceuticals LLCANDACurrent
70121-1221DocetaxelDocetaxelAmneal Pharmaceuticals LLCANDACurrent
70121-1221DocetaxelDocetaxelAmneal Pharmaceuticals LLCANDACurrent
70121-1221DocetaxelDocetaxelAmneal Pharmaceuticals LLCANDACurrent
70121-1221DocetaxelDocetaxelAmneal Biosciences LLCANDACurrent
70121-1222DocetaxelDocetaxelAmneal Pharmaceuticals LLCANDACurrent
70121-1222DocetaxelDocetaxelAmneal Pharmaceuticals LLCANDACurrent
70121-1222DocetaxelDocetaxelAmneal Pharmaceuticals LLCANDACurrent
70121-1222DocetaxelDocetaxelAmneal Pharmaceuticals LLCANDACurrent
70121-1222DocetaxelDocetaxelAmneal Biosciences LLCANDACurrent
70121-1223DocetaxelDocetaxelAmneal Pharmaceuticals LLCANDACurrent
70121-1223DocetaxelDocetaxelAmneal Pharmaceuticals LLCANDACurrent
70121-1223DocetaxelDocetaxelAmneal Pharmaceuticals LLCANDACurrent
70121-1223DocetaxelDocetaxelAmneal Pharmaceuticals LLCANDACurrent
70121-1223DocetaxelDocetaxelAmneal Biosciences LLCANDACurrent