FDA.reportPublic FDA data

Application 205790

Type
ANDA
Sponsor
USPHARMA WINDLAS

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
0440-0604PRASUGRELPrasugrelLiberty Pharmaceuticals, Inc.ANDACurrent
0440-0605PRASUGRELPrasugrelLiberty Pharmaceuticals, Inc.ANDACurrent
67877-604PRASUGRELPrasugrelAscend Laboratories, LLCANDACurrent
67877-604PRASUGRELPrasugrelAscend Laboratories, LLCANDACurrent
67877-604PRASUGRELPrasugrelAscend Laboratories, LLCANDACurrent
67877-605PRASUGRELPrasugrelAscend Laboratories, LLCANDACurrent
67877-605PRASUGRELPrasugrelAscend Laboratories, LLCANDACurrent
67877-605PRASUGRELPrasugrelAscend Laboratories, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
50119ORIG2017-10-19