FDA.reportPublic FDA data

Application 207178

Type
ANDA
Sponsor
APPCO

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
69097-951SILDENAFILSILDENAFILCIPLA USA INC.,ANDACurrent
69097-951SILDENAFILSILDENAFILCIPLA USA INC.,ANDACurrent
69097-952SILDENAFILSILDENAFILCIPLA USA INC.,ANDACurrent
69097-952SILDENAFILSILDENAFILCIPLA USA INC.,ANDACurrent
69097-953SILDENAFILSILDENAFILCIPLA USA INC.,ANDACurrent
69097-953SILDENAFILSILDENAFILCIPLA USA INC.,ANDACurrent
71205-473SILDENAFILSILDENAFILProficient Rx LPANDACurrent
71205-473SILDENAFILSILDENAFILProficient Rx LPANDACurrent
71610-675SILDENAFILSILDENAFILAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-675SILDENAFILSILDENAFILAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-675SILDENAFILSILDENAFILAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-679SILDENAFILSILDENAFILAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-679SILDENAFILSILDENAFILAphena Pharma Solutions - Tennessee, LLCANDACurrent
76282-643SILDENAFILSILDENAFILExelan Pharmaceuticals, Inc.ANDACurrent
76282-643SILDENAFILSILDENAFILExelan Pharmaceuticals, Inc.ANDACurrent
76282-644SILDENAFILSILDENAFILExelan Pharmaceuticals, Inc.ANDACurrent
76282-644SILDENAFILSILDENAFILExelan Pharmaceuticals, Inc.ANDACurrent
76282-645SILDENAFILSILDENAFILExelan Pharmaceuticals, Inc.ANDACurrent
76282-645SILDENAFILSILDENAFILExelan Pharmaceuticals, Inc.ANDACurrent