FDA.reportPublic FDA data

Application 204882

Type
ANDA
Sponsor
RUBICON

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
52817-340SILDENAFILsildenafilTruPharma LLCANDACurrent
52817-340SILDENAFILsildenafilTruPharma LLCANDACurrent
52817-341SILDENAFILsildenafilTruPharma LLCANDACurrent
52817-341SILDENAFILsildenafilTruPharma LLCANDACurrent
52817-342SILDENAFILsildenafilTruPharma LLCANDACurrent
52817-342SILDENAFILsildenafilTruPharma LLCANDACurrent
68071-5251SILDENAFILsildenafilNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5251SILDENAFILsildenafilNuCare Pharmaceuticals,Inc.ANDACurrent
72888-015SILDENAFILsildenafilAdvagen Pharma LtdANDACurrent
72888-015SILDENAFILsildenafilAdvagen Pharma LtdANDACurrent
72888-016SILDENAFILsildenafilAdvagen Pharma LtdANDACurrent
72888-016SILDENAFILsildenafilAdvagen Pharma LtdANDACurrent
72888-017SILDENAFILsildenafilAdvagen Pharma LtdANDACurrent
72888-017SILDENAFILsildenafilAdvagen Pharma LtdANDACurrent