FDA.reportPublic FDA data

Application 201573

Type
ANDA
Sponsor
ANCHEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FENOFIBRIC ACIDCHOLINE FENOFIBRATECAPSULE, DELAYED RELEASE;ORALEQ 135MG FENOFIBRIC ACIDNoNo
002FENOFIBRIC ACIDCHOLINE FENOFIBRATECAPSULE, DELAYED RELEASE;ORALEQ 45MG FENOFIBRIC ACIDNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10370-209Fenofibric AcidFenofibric AcidPar Pharmaceutical, Inc.ANDACurrent
10370-209Fenofibric AcidFenofibric AcidPar Pharmaceutical, Inc.ANDACurrent
10370-210Fenofibric AcidFenofibric AcidPar Pharmaceutical, Inc.ANDACurrent
10370-210Fenofibric AcidFenofibric AcidPar Pharmaceutical, Inc.ANDACurrent
60429-432Fenofibric AcidFenofibric AcidGolden State Medical Supply, Inc.ANDACurrent
60429-432Fenofibric AcidFenofibric AcidGolden State Medical Supply, Inc.ANDACurrent
60429-432Fenofibric AcidFenofibric AcidGolden State Medical SupplyANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
19026ORIG2013-09-19
9911ORIG2013-07-22