FDA.reportPublic FDA data

Application 021316

Type
NDA
Sponsor
COVIS PHARMA BV

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ALTOPREVLOVASTATINTABLET, EXTENDED RELEASE;ORAL10MGNoNo
002ALTOPREVLOVASTATINTABLET, EXTENDED RELEASE;ORAL20MGYesNo
003ALTOPREVLOVASTATINTABLET, EXTENDED RELEASE;ORAL40MGYesNo
004ALTOPREVLOVASTATINTABLET, EXTENDED RELEASE;ORAL60MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70515-628AltoprevlovastatinCovis PharmaNDACurrent
70515-628AltoprevlovastatinCovis Pharma US, IncNDACurrent
70515-628AltoprevlovastatinCovis PharmaNDACurrent
70515-628AltoprevlovastatinCovis PharmaNDACurrent
70515-629AltoprevlovastatinCovis PharmaNDACurrent
70515-629AltoprevlovastatinCovis Pharma US, IncNDACurrent
70515-629AltoprevlovastatinCovis PharmaNDACurrent
70515-629AltoprevlovastatinCovis PharmaNDACurrent
70515-630AltoprevlovastatinCovis PharmaNDACurrent
70515-630AltoprevlovastatinCovis Pharma US, IncNDACurrent
70515-630AltoprevlovastatinCovis PharmaNDACurrent
70515-630AltoprevlovastatinCovis PharmaNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
77836SUPPL 2024-03-15
64717SUPPL2020-09-29
64701SUPPL2020-09-28
52805SUPPL2018-03-02
52795SUPPL2018-03-02
49279SUPPL2017-08-08
49269SUPPL2017-08-08
36641SUPPL2014-05-02
27462SUPPL2014-05-01
15171SUPPL2012-12-28
5010SUPPL2012-12-27
27461SUPPL2012-11-05
15172SUPPL2012-11-02
27460SUPPL2012-05-02
15170SUPPL2012-04-27
42094SUPPL2007-07-09
42095SUPPL2007-04-30
5009SUPPL2007-02-12
36640SUPPL2004-07-21
27459SUPPL2004-07-21
5006SUPPL2004-05-28
36639SUPPL2003-09-30
5008SUPPL2003-09-30
5007SUPPL2003-08-28
21594ORIG2003-04-30
15169SUPPL2002-09-11
36638ORIG2002-06-26
5005ORIG2002-06-26