FDA.reportPublic FDA data

Application 074928

Type
ANDA
Sponsor
EPIC PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NICARDIPINE HYDROCHLORIDENICARDIPINE HYDROCHLORIDECAPSULE;ORAL20MGNoNo
002NICARDIPINE HYDROCHLORIDENICARDIPINE HYDROCHLORIDECAPSULE;ORAL30MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
24658-750Nicardipine HydrochlorideNicardipine HydrochloridePuraCap Laboratories LLC dba Blu PharmaceuticalsANDACurrent
24658-751Nicardipine HydrochlorideNicardipine HydrochloridePuraCap Laboratories LLC dba Blu PharmaceuticalsANDACurrent
42806-501Nicardipine HydrochlorideNicardipine HydrochlorideEpic Pharma, LLCANDACurrent
42806-502Nicardipine HydrochlorideNicardipine HydrochlorideEpic Pharma, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22385ORIG1998-03-19
18373ORIG1998-03-19
8464ORIG1998-03-19