FDA.reportPublic FDA data

Application 204741

Type
ANDA
Sponsor
AMNEAL PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CAPECITABINECAPECITABINETABLET;ORAL150MGNoNo
002CAPECITABINECAPECITABINETABLET;ORAL500MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42291-167CapecitabineCapecitabineAvKARE, Inc.ANDACurrent
50268-154CapecitabineCapecitabineAvPAKANDACurrent
50268-154CapecitabineCapecitabineAvPAKANDACurrent
50268-154CapecitabineCapecitabineAvPAKANDACurrent
65162-843CapecitabineCapecitabineAmneal Pharmaceuticals LLCANDACurrent
65162-843CapecitabineCapecitabineAmneal Pharmaceuticals LLCANDACurrent
65162-843CapecitabineCapecitabineAmneal Pharmaceuticals LLANDACurrent
65162-843CapecitabineCapecitabineAmneal Pharmaceuticals LLCANDACurrent
65162-843CapecitabineCapecitabineAmneal Pharmaceuticals LLCANDACurrent
65162-844CapecitabineCapecitabineAmneal Pharmaceuticals LLCANDACurrent
65162-844CapecitabineCapecitabineAmneal Pharmaceuticals LLCANDACurrent
65162-844CapecitabineCapecitabineAmneal Pharmaceuticals LLANDACurrent
65162-844CapecitabineCapecitabineAmneal Pharmaceuticals LLCANDACurrent
65162-844CapecitabineCapecitabineAmneal Pharmaceuticals LLCANDACurrent