FDA.reportPublic FDA data

Application 202023

Type
ANDA
Sponsor
AMNEAL PHARMS NY

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SILDENAFIL CITRATESILDENAFIL CITRATETABLET;ORALEQ 25MG BASENoNo
002SILDENAFIL CITRATESILDENAFIL CITRATETABLET;ORALEQ 50MG BASENoNo
003SILDENAFIL CITRATESILDENAFIL CITRATETABLET;ORALEQ 100MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-4644SildenafilSildenafilA-S Medication SolutionsANDACurrent
50090-4644SildenafilSildenafilA-S Medication SolutionsANDACurrent
50090-4646SildenafilSildenafilA-S Medication SolutionsANDACurrent
50090-4646SildenafilSildenafilA-S Medication SolutionsANDACurrent
60219-1751SildenafilSildenafilAmneal Pharmaceuticals LLCANDACurrent
60219-1751SildenafilSildenafilAmneal Pharmaceuticals NY LLCANDACurrent
60219-1751SildenafilSildenafilAmneal Pharmaceuticals NY LLCANDACurrent
60219-1751SildenafilSildenafilAmneal Pharmaceuticals NY LLCANDACurrent
60219-1752SildenafilSildenafilAmneal Pharmaceuticals LLCANDACurrent
60219-1752SildenafilSildenafilAmneal Pharmaceuticals NY LLCANDACurrent
60219-1752SildenafilSildenafilAmneal Pharmaceuticals NY LLCANDACurrent
60219-1752SildenafilSildenafilAmneal Pharmaceuticals NY LLCANDACurrent
60219-1753SildenafilSildenafilAmneal Pharmaceuticals LLCANDACurrent
60219-1753SildenafilSildenafilAmneal Pharmaceuticals NY LLCANDACurrent
60219-1753SildenafilSildenafilAmneal Pharmaceuticals NY LLCANDACurrent
60219-1753SildenafilSildenafilAmneal Pharmaceuticals NY LLCANDACurrent
63629-7833SildenafilSildenafilBryant Ranch PrepackANDACurrent
63629-7833SildenafilSildenafilBryant Ranch PrepackANDACurrent
63629-7833SildenafilSildenafilBryant Ranch PrepackANDACurrent
68071-2898SildenafilSildenafilNuCare Pharmaceuticals,Inc.ANDACurrent
71335-0969SildenafilSildenafilBryant Ranch PrepackANDACurrent
71335-0969SildenafilSildenafilBryant Ranch PrepackANDACurrent
71335-0969SildenafilSildenafilBryant Ranch PrepackANDACurrent
73160-005sildenafil citratesildenafilCarePartners Pharmacy, LLCANDACurrent