FDA.reportPublic FDA data

Application 206699

Type
ANDA
Sponsor
AMNEAL PHARMS CO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PARICALCITOLPARICALCITOLSOLUTION;INTRAVENOUS0.002MG/ML (0.002MG/ML)NoNo
002PARICALCITOLPARICALCITOLSOLUTION;INTRAVENOUS0.005MG/ML (0.005MG/ML)NoNo
003PARICALCITOLPARICALCITOLSOLUTION;INTRAVENOUS0.01MG/2ML (0.005MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70121-1033ParicalcitolParicalcitolAmneal Pharmaceuticals LLCANDACurrent
70121-1033ParicalcitolParicalcitolAmneal Pharmaceuticals LLCANDACurrent
70121-1033ParicalcitolParicalcitolAmneal Pharmaceuticals LLCANDACurrent
70121-1033ParicalcitolParicalcitolAmneal Biosciences LLCANDACurrent
70121-1034ParicalcitolParicalcitolAmneal Pharmaceuticals LLCANDACurrent
70121-1034ParicalcitolParicalcitolAmneal Pharmaceuticals LLCANDACurrent
70121-1034ParicalcitolParicalcitolAmneal Pharmaceuticals LLCANDACurrent
70121-1034ParicalcitolParicalcitolAmneal Biosciences LLCANDACurrent
70121-1035ParicalcitolParicalcitolAmneal Pharmaceuticals LLCANDACurrent
70121-1035ParicalcitolParicalcitolAmneal Pharmaceuticals LLCANDACurrent
70121-1035ParicalcitolParicalcitolAmneal Pharmaceuticals LLCANDACurrent
70121-1035ParicalcitolParicalcitolAmneal Biosciences LLCANDACurrent
70121-1036ParicalcitolParicalcitolAmneal Pharmaceuticals LLCANDACurrent
70121-1036ParicalcitolParicalcitolAmneal Pharmaceuticals LLCANDACurrent
70121-1036ParicalcitolParicalcitolAmneal Pharmaceuticals LLCANDACurrent
70121-1036ParicalcitolParicalcitolAmneal Biosciences LLCANDACurrent