FDA.reportPublic FDA data

Application 020702

Type
NDA
Sponsor
PFIZER

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LIPITORATORVASTATIN CALCIUMTABLET;ORALEQ 10MG BASEYesNo
002LIPITORATORVASTATIN CALCIUMTABLET;ORALEQ 20MG BASEYesNo
003LIPITORATORVASTATIN CALCIUMTABLET;ORALEQ 40MG BASEYesNo
004LIPITORATORVASTATIN CALCIUMTABLET;ORALEQ 80MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0071-0155Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0155Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0155Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0155Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0155Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0155Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0155Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0155Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0155Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0155Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0155Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0155Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0155Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0155Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0156Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0156Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0156Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0156Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0156Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0156Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0156Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0156Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0156Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0156Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0156Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0156Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0156Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0156Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0157Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0157Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0157Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0157Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0157Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0157Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0157Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0157Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0157Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0157Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0157Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0157Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0157Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0157Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0158Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0158Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0158Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0158Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0158Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0158Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0158Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0158Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0158Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0158Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0158Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0158Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0158Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0071-0158Lipitoratorvastatin calciumParke-Davis Div of Pfizer IncNDACurrent
0179-0141ATORVASTATIN CALCIUMATORVASTATIN CALCIUMKAISER FOUNDATION HOSPITALSNDA AUTHORIZED GENERICCurrent
0179-0214ATORVASTATIN CALCIUMATORVASTATIN CALCIUMKAISER FOUNDATION HOSPITALSNDA AUTHORIZED GENERICCurrent
0179-0215ATORVASTATIN CALCIUMATORVASTATIN CALCIUMKAISER FOUNDATION HOSPITALSNDA AUTHORIZED GENERICCurrent
0179-0216ATORVASTATIN CALCIUMATORVASTATIN CALCIUMKAISER FOUNDATION HOSPITALSNDA AUTHORIZED GENERICCurrent
21695-255Lipitoratorvastatin calciumRebel Distributors CorpNDACurrent
42254-019ATORVASTATIN CALCIUMATORVASTATIN CALCIUMRebel Distributors CorpNDA AUTHORIZED GENERICCurrent
42254-261ATORVASTATIN CALCIUMATORVASTATIN CALCIUMRebel Distributors CorpNDA AUTHORIZED GENERICCurrent
42254-267ATORVASTATIN CALCIUMATORVASTATIN CALCIUMRebel Distributors CorpNDA AUTHORIZED GENERICCurrent
42254-307ATORVASTATIN CALCIUMATORVASTATIN CALCIUMRebel Distributors CorpNDA AUTHORIZED GENERICCurrent
43353-120ATORVASTATIN CALCIUMATORVASTATIN CALCIUMAphena Pharma Solutions - Tennessee, LLCNDA AUTHORIZED GENERICCurrent
43353-120ATORVASTATIN CALCIUMATORVASTATIN CALCIUMAphena Pharma Solutions - Tennessee, LLCNDA AUTHORIZED GENERICCurrent
43353-826ATORVASTATIN CALCIUMATORVASTATIN CALCIUMAphena Pharma Solutions - Tennessee, LLCNDA AUTHORIZED GENERICCurrent
43353-826ATORVASTATIN CALCIUMATORVASTATIN CALCIUMAphena Pharma Solutions - Tennessee, LLCNDA AUTHORIZED GENERICCurrent
43353-827ATORVASTATIN CALCIUMATORVASTATIN CALCIUMAphena Pharma Solutions - Tennessee, LLCNDA AUTHORIZED GENERICCurrent
43353-827ATORVASTATIN CALCIUMATORVASTATIN CALCIUMAphena Pharma Solutions - Tennessee, LLCNDA AUTHORIZED GENERICCurrent
43353-892ATORVASTATIN CALCIUMATORVASTATIN CALCIUMAphena Pharma Solutions - Tennessee, LLCNDA AUTHORIZED GENERICCurrent
43353-892ATORVASTATIN CALCIUMATORVASTATIN CALCIUMAphena Pharma Solutions - Tennessee, LLCNDA AUTHORIZED GENERICCurrent
49299-1090LIPITORatorvastatin calciumPHARMAKON, LLCNDACurrent
49299-1091LIPITORatorvastatin calciumPHARMAKON, LLCNDACurrent
49299-1092LIPITORatorvastatin calciumPHARMAKON, LLCNDACurrent
49299-1093LIPITORatorvastatin calciumPHARMAKON, LLCNDACurrent
51655-880Atorvastatin CalciumAtorvastatin CalciumNorthwind PharmaceuticalsANDACurrent
53808-0951ATORVASTATIN CALCIUMATORVASTATIN CALCIUMState of Florida DOH Central PharmacyNDA AUTHORIZED GENERICCurrent
55289-800Lipitoratorvastatin calcium trihydratePD-Rx Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78046SUPPL 2024-04-03
78041SUPPL 2024-04-03
72893SUPPL2022-12-15
72831SUPPL2022-12-09
65260SUPPL2020-11-18
65234SUPPL2020-11-16
64723SUPPL2020-09-29
64699SUPPL2020-09-28
61105SUPPL2019-11-29
61091SUPPL2019-11-29
58348SUPPL2019-04-22
58330SUPPL2019-04-15
55225SUPPL2018-08-20
55168SUPPL2018-08-13
48846SUPPL2017-06-27
48845SUPPL2017-06-27
48840SUPPL2017-06-27
48839SUPPL2017-06-27
35179SUPPL2015-03-17
3135SUPPL2015-03-13
35178SUPPL2014-05-28
25577SUPPL2014-05-22
20856SUPPL2013-08-06
3134SUPPL2012-11-05
3133SUPPL2012-11-05
35177SUPPL2012-11-02
13249SUPPL2012-11-02
41591SUPPL2012-03-30
35176SUPPL2012-02-28
25576SUPPL2012-02-28
3132SUPPL2010-11-05
20841ORIG2010-03-16
35174SUPPL2009-06-22
35175SUPPL2009-04-03
25575SUPPL2009-04-01
41590SUPPL2008-08-01
20855SUPPL2008-08-01
41587SUPPL2008-07-31
20850SUPPL2008-02-19
20854SUPPL2007-12-06
20853SUPPL2007-12-06
20852SUPPL2007-12-06
41586SUPPL2007-11-19
41584SUPPL2007-11-19
41583SUPPL2007-11-19
20847SUPPL2007-11-19
20846SUPPL2007-11-19
20845SUPPL2007-11-19
25574SUPPL2007-10-04
41589SUPPL2007-09-26
41588SUPPL2007-09-26
35173SUPPL2007-09-26
41582SUPPL2007-07-06
20849SUPPL2007-07-06
25572SUPPL2007-03-07
13248SUPPL2007-03-07
25573SUPPL2007-01-25
35172SUPPL2007-01-18
35171SUPPL2006-08-09
3130SUPPL2006-08-09
23061SUPPL2006-06-28
3131SUPPL2006-06-27
3128SUPPL2005-10-20
3129SUPPL2005-10-14
35170SUPPL2005-09-30
25571SUPPL2004-08-02
13245SUPPL2004-06-08
3126SUPPL2004-06-08
43563SUPPL2004-05-27
25568SUPPL2004-05-26
13247SUPPL2003-10-10
25570SUPPL2003-10-09
3127SUPPL2003-06-08
13246SUPPL2003-05-29
25569SUPPL2002-10-18
13244SUPPL2002-10-18
35169SUPPL2002-04-22
3125SUPPL2002-04-22
20851SUPPL2002-04-10
25567SUPPL2001-06-15
13243SUPPL2001-06-15
41585SUPPL2001-02-26
25566SUPPL1999-12-02
20848SUPPL1998-12-14
20843SUPPL1998-11-12
41581SUPPL1998-10-23
25565SUPPL1998-07-10
20844SUPPL1998-07-10
3124SUPPL1998-07-10
20842SUPPL1997-11-28