FDA.reportPublic FDA data

Application 204327

Type
ANDA
Sponsor
AMNEAL PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PARICALCITOLPARICALCITOLCAPSULE;ORAL1MCGNoNo
002PARICALCITOLPARICALCITOLCAPSULE;ORAL2MCGNoNo
003PARICALCITOLPARICALCITOLCAPSULE;ORAL4MCGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
65162-822ParicalcitolParicalcitolAmneal Pharmaceuticals LLCANDACurrent
65162-822ParicalcitolParicalcitolAmneal Pharmaceuticals LLCANDACurrent
65162-822ParicalcitolParicalcitolAmneal Pharmaceuticals LLCANDACurrent
65162-822ParicalcitolParicalcitolAmneal Pharmaceuticals LLCANDACurrent
65162-823ParicalcitolParicalcitolAmneal Pharmaceuticals LLCANDACurrent
65162-823ParicalcitolParicalcitolAmneal Pharmaceuticals LLCANDACurrent
65162-823ParicalcitolParicalcitolAmneal Pharmaceuticals LLCANDACurrent
65162-823ParicalcitolParicalcitolAmneal Pharmaceuticals LLCANDACurrent
65162-824ParicalcitolParicalcitolAmneal Pharmaceuticals LLCANDACurrent
65162-824ParicalcitolParicalcitolAmneal Pharmaceuticals LLCANDACurrent
65162-824ParicalcitolParicalcitolAmneal Pharmaceuticals LLCANDACurrent
65162-824ParicalcitolParicalcitolAmneal Pharmaceuticals LLCANDACurrent