FDA.reportPublic FDA data

Application 203988

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SILDENAFIL CITRATESILDENAFIL CITRATESOLUTION;INTRAVENOUSEQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55150-166SildenafilSildenafil CitrateAuroMedics Pharma LLCANDACurrent
55150-166SildenafilSildenafil CitrateAuroMedics Pharma LLCANDACurrent
55150-166SildenafilSildenafil CitrateAuroMedics Pharma LLCANDACurrent
55150-166SildenafilSildenafil CitrateAuroMedics Pharma LLCANDACurrent