FDA.reportPublic FDA data

Application 021151

Type
NDA
Sponsor
COVIS PHARMA BV

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BETAPACE AFSOTALOL HYDROCHLORIDETABLET;ORAL80MGYesNo
002BETAPACE AFSOTALOL HYDROCHLORIDETABLET;ORAL120MGYesNo
003BETAPACE AFSOTALOL HYDROCHLORIDETABLET;ORAL160MGYesYes
005BETAPACE AFSOTALOL HYDROCHLORIDETABLET;ORAL100MGNoNo
006BETAPACE AFSOTALOL HYDROCHLORIDETABLET;ORAL40MGNoNo
007BETAPACE AFSOTALOL HYDROCHLORIDETABLET;ORAL60MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
13672-054Betapace AFsotalol HClSkyepharma Production SASNDACurrent
13672-054Betapace AFsotalol HClSkyepharma Production SASNDACurrent
13672-054Betapace AFsotalol HClSkyePharma Production SASNDACurrent
13672-055Betapace AFsotalol HClSkyePharma Production SASNDACurrent
13672-055Betapace AFsotalol HClSkyepharma Production SASNDACurrent
13672-055Betapace AFsotalol HClSkyepharma Production SASNDACurrent
13672-056Betapace AFsotalol HClSkyePharma Production SASNDACurrent
13672-056Betapace AFsotalol HClSkyepharma Production SASNDACurrent
13672-056Betapace AFsotalol HClSkyepharma Production SASNDACurrent
70515-115BETAPACE AFsotalol hydrochlorideCovis Pharma US, IncNDACurrent
70515-115BETAPACE AFsotalol hydrochlorideCovis PharmaNDACurrent
70515-115BETAPACE AFsotalol hydrochlorideCovis PharmaNDACurrent
70515-116BETAPACE AFsotalol hydrochlorideCovis Pharma US, IncNDACurrent
70515-116BETAPACE AFsotalol hydrochlorideCovis PharmaNDACurrent
70515-116BETAPACE AFsotalol hydrochlorideCovis PharmaNDACurrent
70515-119BETAPACE AFsotalol hydrochlorideCovis Pharma US, IncNDACurrent
70515-119BETAPACE AFsotalol hydrochlorideCovis PharmaNDACurrent
70515-119BETAPACE AFsotalol hydrochlorideCovis PharmaNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
36220SUPPL2011-08-24
26912SUPPL2011-08-18
14509SUPPL2011-02-09
4477SUPPL2011-02-09
41987ORIG2006-01-11
4476SUPPL2003-04-18
26911SUPPL2003-03-26
14508ORIG2000-02-22
4475ORIG2000-02-22