FDA.reportPublic FDA data

Application 075541

Type
ANDA
Sponsor
EPIC PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BETAXOLOL HYDROCHLORIDEBETAXOLOL HYDROCHLORIDETABLET;ORAL10MGNoNo
002BETAXOLOL HYDROCHLORIDEBETAXOLOL HYDROCHLORIDETABLET;ORAL20MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10135-623BetaxololBetaxololMarlex Pharmaceuticals IncANDACurrent
10135-624BetaxololBetaxololMarlex Pharmaceuticals IncANDACurrent
24658-700BetaxololBetaxololPuraCap Laboratories LLCANDACurrent
24658-700BetaxololBetaxololPuraCap Laboratories LLC dba Blu PharmaceuticalsANDACurrent
24658-701BetaxololBetaxololPuraCap Laboratories LLCANDACurrent
24658-701BetaxololBetaxololPuraCap Laboratories LLC dba Blu PharmaceuticalsANDACurrent
42806-038BetaxololBetaxololEpic Pharma LLCANDACurrent
42806-039BetaxololBetaxololEpic Pharma LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
18412SUPPL2014-12-31
8713SUPPL2014-12-31
30927ORIG1999-10-22