FDA.reportPublic FDA data

Application 020356

Type
NDA
Sponsor
COVIS PHARMA BV

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SULARNISOLDIPINETABLET, EXTENDED RELEASE;ORAL10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002SULARNISOLDIPINETABLET, EXTENDED RELEASE;ORAL20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
003SULARNISOLDIPINETABLET, EXTENDED RELEASE;ORAL30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
004SULARNISOLDIPINETABLET, EXTENDED RELEASE;ORAL40MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
005SULARNISOLDIPINETABLET, EXTENDED RELEASE;ORAL34MGYesYes
006SULARNISOLDIPINETABLET, EXTENDED RELEASE;ORAL25.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
007SULARNISOLDIPINETABLET, EXTENDED RELEASE;ORAL17MGYesYes
008SULARNISOLDIPINETABLET, EXTENDED RELEASE;ORAL8.5MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0677-1978NisoldipineNisoldipineUnited Research Laboratories, Inc.NDA AUTHORIZED GENERICCurrent
0677-1979NisoldipineNisoldipineUnited Research Laboratories, Inc.NDA AUTHORIZED GENERICCurrent
0677-1980NisoldipineNisoldipineUnited Research Laboratories, Inc.NDA AUTHORIZED GENERICCurrent
0677-1981NisoldipineNisoldipineUnited Research Laboratories, Inc.NDA AUTHORIZED GENERICCurrent
59630-500SULARNisoldipineShionogi Inc.NDACurrent
59630-501SULARNisoldipineShionogi Inc.NDACurrent
59630-503SULARNisoldipineShionogi Inc.NDACurrent
66993-472NisoldipineNisoldipinePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-472NisoldipineNisoldipinePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-473NisoldipineNisoldipinePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-473NisoldipineNisoldipinePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-475NisoldipineNisoldipinePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-475NisoldipineNisoldipinePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
70515-500SularnisoldipineCovis PharmaNDACurrent
70515-500SularnisoldipineCovis Pharma US, IncNDACurrent
70515-500SularnisoldipineCovis PharmaNDACurrent
70515-501SularnisoldipineCovis PharmaNDACurrent
70515-501SularnisoldipineCovis Pharma US, IncNDACurrent
70515-501SularnisoldipineCovis PharmaNDACurrent
70515-503SularnisoldipineCovis PharmaNDACurrent
70515-503SularnisoldipineCovis Pharma US, IncNDACurrent
70515-503SularnisoldipineCovis PharmaNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
48749ORIG2017-06-16
48713SUPPL2017-06-14
20603SUPPL2012-02-28
24813SUPPL2008-01-09
41289SUPPL2001-06-04
20602SUPPL2001-06-04
57428ORIG1995-02-02