FDA.reportPublic FDA data

Application 021366

Type
NDA
Sponsor
IPR

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002CRESTORROSUVASTATIN CALCIUMTABLET;ORAL5MGYesNo
003CRESTORROSUVASTATIN CALCIUMTABLET;ORAL10MGYesNo
004CRESTORROSUVASTATIN CALCIUMTABLET;ORAL20MGYesNo
005CRESTORROSUVASTATIN CALCIUMTABLET;ORAL40MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0310-0751CRESTORRosuvastatin calciumAstraZeneca Pharmaceuticals LPNDACurrent
0310-0751CRESTORRosuvastatin calciumAstraZeneca Pharmaceuticals LPNDACurrent
0310-0751CRESTORRosuvastatin calciumAstraZeneca Pharmaceuticals LPNDACurrent
0310-0751CRESTORRosuvastatin calciumAstraZeneca Pharmaceuticals LPNDACurrent
0310-0751CRESTORRosuvastatin calciumAstraZeneca Pharmaceuticals LPNDACurrent
0310-0751CRESTORRosuvastatin calciumAstraZeneca Pharmaceuticals LPNDACurrent
0310-0751CRESTORRosuvastatin calciumAstraZeneca Pharmaceuticals LPNDACurrent
0310-0752CRESTORRosuvastatin calciumAstraZeneca Pharmaceuticals LPNDACurrent
0310-0752CRESTORRosuvastatin calciumAstraZeneca Pharmaceuticals LPNDACurrent
0310-0752CRESTORRosuvastatin calciumAstraZeneca Pharmaceuticals LPNDACurrent
0310-0752CRESTORRosuvastatin calciumAstraZeneca Pharmaceuticals LPNDACurrent
0310-0752CRESTORRosuvastatin calciumAstraZeneca Pharmaceuticals LPNDACurrent
0310-0752CRESTORRosuvastatin calciumAstraZeneca Pharmaceuticals LPNDACurrent
0310-0752CRESTORRosuvastatin calciumAstraZeneca Pharmaceuticals LPNDACurrent
0310-0754CRESTORRosuvastatin calciumAstraZeneca Pharmaceuticals LPNDACurrent
0310-0754CRESTORRosuvastatin calciumAstraZeneca Pharmaceuticals LPNDACurrent
0310-0754CRESTORRosuvastatin calciumAstraZeneca Pharmaceuticals LPNDACurrent
0310-0754CRESTORRosuvastatin calciumAstraZeneca Pharmaceuticals LPNDACurrent
0310-0754CRESTORRosuvastatin calciumAstraZeneca Pharmaceuticals LPNDACurrent
0310-0754CRESTORRosuvastatin calciumAstraZeneca Pharmaceuticals LPNDACurrent
0310-0754CRESTORRosuvastatin calciumAstraZeneca Pharmaceuticals LPNDACurrent
0310-0755CRESTORRosuvastatin calciumAstraZeneca Pharmaceuticals LPNDACurrent
0310-0755CRESTORRosuvastatin calciumAstraZeneca Pharmaceuticals LPNDACurrent
0310-0755CRESTORRosuvastatin calciumAstraZeneca Pharmaceuticals LPNDACurrent
0310-0755CRESTORRosuvastatin calciumAstraZeneca Pharmaceuticals LPNDACurrent
0310-0755CRESTORRosuvastatin calciumAstraZeneca Pharmaceuticals LPNDACurrent
0310-0755CRESTORRosuvastatin calciumAstraZeneca Pharmaceuticals LPNDACurrent
0310-0755CRESTORRosuvastatin calciumAstraZeneca Pharmaceuticals LPNDACurrent
0310-7560CrestorRosuvastatin calciumAstraZeneca Pharmaceuticals LPNDACurrent
0310-7570CrestorRosuvastatin calciumAstraZeneca Pharmaceuticals LPNDACurrent
0310-7580CrestorRosuvastatin calciumAstraZeneca Pharmaceuticals LPNDACurrent
0310-7580CrestorRosuvastatin calciumAstraZeneca Pharmaceuticals LPNDACurrent
0310-7580CrestorRosuvastatin calciumAstraZeneca Pharmaceuticals LPNDACurrent
0310-7590CrestorRosuvastatin calciumAstraZeneca Pharmaceuticals LPNDACurrent
0310-7590CrestorRosuvastatin calciumAstraZeneca Pharmaceuticals LPNDACurrent
0310-7590CrestorRosuvastatin calciumAstraZeneca Pharmaceuticals LPNDACurrent
21695-287CrestorRosuvastatin calciumRebel Distributors CorpNDACurrent
21695-288CrestorRosuvastatin calciumRebel Distributors CorpNDACurrent
21695-659CrestorRosuvastatin calciumRebel Distributors CorpNDACurrent
21695-759CrestorRosuvastatin calciumRebel Distributors CorpNDACurrent
35356-413CrestorRosuvastatin calciumLake Erie Medical DBA Quality Care Products LLCNDACurrent
43353-031CRESTORRosuvastatin calciumAphena Pharma Solutions - Tennessee, LLCNDACurrent
43353-289CRESTORRosuvastatin calciumAphena Pharma Solutions - Tennessee, LLCNDACurrent
43353-290CRESTORRosuvastatin calciumAphena Pharma Solutions - Tennessee, LLCNDACurrent
50090-1097CRESTORRosuvastatin calciumA-S Medication SolutionsNDACurrent
50090-1097CRESTORRosuvastatin calciumA-S Medication SolutionsNDACurrent
50090-1621CRESTORRosuvastatin calciumA-S Medication SolutionsNDACurrent
52959-629CRESTORRosuvastatin calciumH.J. Harkins Company, Inc.NDACurrent
55154-6921CRESTORRosuvastatin calciumCardinal HealthNDACurrent
55154-6924CRESTORRosuvastatin calciumCardinal HealthNDACurrent
55289-932CRESTORRosuvastatin calciumPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-932CRESTORRosuvastatin calciumPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-932CRESTORRosuvastatin calciumPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-932CRESTORRosuvastatin calciumPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-932CRESTORRosuvastatin calciumPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-935CRESTORRosuvastatin calciumPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-935CRESTORRosuvastatin calciumPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-935CRESTORRosuvastatin calciumPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-935CRESTORRosuvastatin calciumPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-935CRESTORRosuvastatin calciumPD-Rx Pharmaceuticals, Inc.NDACurrent
63629-3381CRESTORRosuvastatin calciumBryant Ranch PrepackNDACurrent
63629-3381CRESTORRosuvastatin calciumBryant Ranch PrepackNDACurrent
63629-3381CRESTORRosuvastatin calciumBryant Ranch PrepackNDACurrent
63629-4311CRESTORRosuvastatin calciumBryant Ranch PrepackNDACurrent
63629-4372CRESTORRosuvastatin calciumBryant Ranch PrepackNDACurrent
63629-4372CRESTORRosuvastatin calciumBryant Ranch PrepackNDACurrent
63629-6372CRESTORRosuvastatin calciumBryant Ranch PrepackNDACurrent
63629-6372CRESTORRosuvastatin calciumBryant Ranch PrepackNDACurrent
63629-6427CRESTORRosuvastatin calciumBryant Ranch PrepackNDACurrent
63629-6427CRESTORRosuvastatin calciumBryant Ranch PrepackNDACurrent
63629-6427CRESTORRosuvastatin calciumBryant Ranch PrepackNDACurrent
63629-6427CRESTORRosuvastatin calciumBryant Ranch PrepackNDACurrent
63629-6924CRESTORRosuvastatin calciumBryant Ranch PrepackNDACurrent
63629-6924CRESTORRosuvastatin calciumBryant Ranch PrepackNDACurrent
63629-6924CRESTORRosuvastatin calciumBryant Ranch PrepackNDACurrent
63629-6924CRESTORRosuvastatin calciumBryant Ranch PrepackNDACurrent
68151-4634CRESTORRosuvastatin calciumCarilion Materials ManagementNDACurrent
69189-0752CRESTORRosuvastatin calciumAvera McKennan HospitalNDACurrent
70518-1904CRESTORRosuvastatin calciumREMEDYREPACK INC.NDACurrent
70518-1905CRESTORRosuvastatin calciumREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85782SUPPL 2026-05-01
83891SUPPL 2025-11-19
79279SUPPL 2024-08-02
79264SUPPL 2024-08-02
74924SUPPL 2023-07-31
74915SUPPL 2023-07-28
73227SUPPL2023-01-17
73178SUPPL2023-01-17
73177SUPPL2023-01-17
64729SUPPL2020-09-29
64702SUPPL2020-09-28
63313SUPPL2020-05-28
63312SUPPL2020-05-28
63274SUPPL2020-05-22
63273SUPPL2020-05-22
56451SUPPL2018-11-15
56416SUPPL2018-11-12
49899SUPPL2017-10-01
49270SUPPL2017-08-08
36782SUPPL2016-06-01
5196SUPPL2016-05-31
36780SUPPL2015-11-25
27614SUPPL2015-11-23
36781SUPPL2015-06-04
5195SUPPL2015-06-04
36779SUPPL2014-08-12
27613SUPPL2014-07-10
36778SUPPL2013-08-09
15316SUPPL2013-08-09
27612SUPPL2013-08-08
5194SUPPL2013-08-08
27611SUPPL2012-12-26
15315SUPPL2012-12-21
27610SUPPL2012-11-05
5193SUPPL2012-11-05
36777SUPPL2012-11-02
36776SUPPL2012-11-02
21622SUPPL2012-03-30
15314SUPPL2012-02-28
5192SUPPL2012-02-28
23997SUPPL2011-12-16
23998SUPPL2011-11-01
42122SUPPL2011-09-22
27609SUPPL2010-11-26
15313SUPPL2010-11-26
42123SUPPL2010-07-27
24194SUPPL2010-07-27
5191SUPPL2010-02-12
36774SUPPL2010-02-08
27608SUPPL2010-01-28
36775SUPPL2010-01-24
27607SUPPL2009-11-25
15312SUPPL2009-10-21
52326SUPPL2009-07-07
36773SUPPL2009-04-03
27606SUPPL2009-04-01
36772SUPPL2009-01-29
27605SUPPL2009-01-26
27604SUPPL2008-11-13
36771SUPPL2008-11-07
27603SUPPL2007-11-19
36770SUPPL2007-11-13
5190SUPPL2007-07-27
15311SUPPL2007-07-24
27602SUPPL2005-03-03
15310SUPPL2005-03-02
23651ORIG2004-03-24
21621ORIG2004-01-29
27601ORIG2004-01-20
15309ORIG2003-08-14
53073ORIG1900-01-01
53072ORIG1900-01-01
53071ORIG1900-01-01
52890ORIG1900-01-01