FDA.reportPublic FDA data

Application 205927

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PRASUGRELPRASUGREL HYDROCHLORIDETABLET;ORALEQ 5MG BASENoNo
002PRASUGRELPRASUGREL HYDROCHLORIDETABLET;ORALEQ 10MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-5185PrasugrelPrasugrelMylan Pharmaceuticals Inc.ANDACurrent
0378-5185PrasugrelPrasugrelMylan Pharmaceuticals Inc.ANDACurrent
0378-5185PrasugrelPrasugrelMylan Pharmaceuticals Inc.ANDACurrent
0378-5185PrasugrelPrasugrelMylan Pharmaceuticals Inc.ANDACurrent
0378-5185PrasugrelPrasugrelMylan Pharmaceuticals Inc.ANDACurrent
0378-5185PrasugrelPrasugrelMylan Pharmaceuticals Inc.ANDACurrent
0378-5186PrasugrelPrasugrelMylan Pharmaceuticals Inc.ANDACurrent
0378-5186PrasugrelPrasugrelMylan Pharmaceuticals Inc.ANDACurrent
0378-5186PrasugrelPrasugrelMylan Pharmaceuticals Inc.ANDACurrent
0378-5186PrasugrelPrasugrelMylan Pharmaceuticals Inc.ANDACurrent
0378-5186PrasugrelPrasugrelMylan Pharmaceuticals Inc.ANDACurrent
0378-5186PrasugrelPrasugrelMylan Pharmaceuticals Inc.ANDACurrent
51407-444PrasugrelPrasugrelGolden State Medical Supply, Inc.ANDACurrent
51407-444PrasugrelPrasugrelGolden State Medical Supply, Inc.ANDACurrent
51407-444PrasugrelPrasugrelGolden State Medical Supply, Inc.ANDACurrent
51407-445PrasugrelPrasugrelGolden State Medical Supply, Inc.ANDACurrent
51407-445PrasugrelPrasugrelGolden State Medical Supply, Inc.ANDACurrent
51407-445PrasugrelPrasugrelGolden State Medical Supply, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
48989ORIG2017-07-14
48983ORIG2017-07-14