FDA.reportPublic FDA data

Application 077691

Type
ANDA
Sponsor
AUROBINDO PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SIMVASTATINSIMVASTATINTABLET;ORAL5MGNoNo
002SIMVASTATINSIMVASTATINTABLET;ORAL10MGNoNo
003SIMVASTATINSIMVASTATINTABLET;ORAL20MGNoNo
004SIMVASTATINSIMVASTATINTABLET;ORAL40MGNoNo
005SIMVASTATINSIMVASTATINTABLET;ORAL80MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-7704SimvastatinSimvastatinNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7705SimvastatinSimvastatinNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7706SimvastatinSimvastatinNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7707SimvastatinSimvastatinNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
13107-050SimvastatinSimvastatinAurolife Pharma LLCANDACurrent
13107-051SimvastatinSimvastatinAurolife Pharma LLCANDACurrent
13107-052SimvastatinSimvastatinAurolife Pharma LLCANDACurrent
13107-053SimvastatinSimvastatinAurolife Pharma LLCANDACurrent
13107-054SimvastatinSimvastatinAurolife Pharma LLCANDACurrent
16714-681SimvastatinSimvastatinNorthStar Rx LLCANDACurrent
16714-681SimvastatinSimvastatinNorthStar Rx LLCANDACurrent
16714-681SimvastatinSimvastatinNorthStar Rx LLCANDACurrent
16714-681SimvastatinSimvastatinNorthStar Rx LLCANDACurrent
16714-681SimvastatinSimvastatinNorthStar Rx LLCANDACurrent
16714-681SimvastatinSimvastatinNorthStar Rx LLCANDACurrent
16714-681SimvastatinSimvastatinNorthStar Rx LLCANDACurrent
16714-681SimvastatinSimvastatinNorthStar Rx LLCANDACurrent
16714-681SimvastatinSimvastatinNorthStar Rx LLCANDACurrent
16714-682SimvastatinSimvastatinNorthStar Rx LLCANDACurrent
16714-682SimvastatinSimvastatinNorthStar Rx LLCANDACurrent
16714-682SimvastatinSimvastatinNorthStar Rx LLCANDACurrent
16714-682SimvastatinSimvastatinNorthStar Rx LLCANDACurrent
16714-682SimvastatinSimvastatinNorthStar Rx LLCANDACurrent
16714-682SimvastatinSimvastatinNorthStar Rx LLCANDACurrent
16714-682SimvastatinSimvastatinNorthStar Rx LLCANDACurrent
16714-682SimvastatinSimvastatinNorthStar Rx LLCANDACurrent
16714-682SimvastatinSimvastatinNorthStar Rx LLCANDACurrent
16714-683SimvastatinSimvastatinNorthStar Rx LLCANDACurrent
16714-683SimvastatinSimvastatinNorthStar Rx LLCANDACurrent
16714-683SimvastatinSimvastatinNorthStar Rx LLCANDACurrent
16714-683SimvastatinSimvastatinNorthStar Rx LLCANDACurrent
16714-683SimvastatinSimvastatinNorthStar Rx LLCANDACurrent
16714-683SimvastatinSimvastatinNorthStar Rx LLCANDACurrent
16714-683SimvastatinSimvastatinNorthStar Rx LLCANDACurrent
16714-683SimvastatinSimvastatinNorthStar Rx LLCANDACurrent
16714-683SimvastatinSimvastatinNorthStar Rx LLCANDACurrent
16714-684SimvastatinSimvastatinNorthStar Rx LLCANDACurrent
16714-684SimvastatinSimvastatinNorthStar Rx LLCANDACurrent
16714-684SimvastatinSimvastatinNorthStar Rx LLCANDACurrent
16714-684SimvastatinSimvastatinNorthStar Rx LLCANDACurrent
16714-684SimvastatinSimvastatinNorthStar Rx LLCANDACurrent
16714-684SimvastatinSimvastatinNorthStar Rx LLCANDACurrent
16714-684SimvastatinSimvastatinNorthStar Rx LLCANDACurrent
16714-684SimvastatinSimvastatinNorthStar Rx LLCANDACurrent
16714-684SimvastatinSimvastatinNorthStar Rx LLCANDACurrent
16714-685SimvastatinSimvastatinNorthStar Rx LLCANDACurrent
16714-685SimvastatinSimvastatinNorthStar Rx LLCANDACurrent
16714-685SimvastatinSimvastatinNorthStar Rx LLCANDACurrent
16714-685SimvastatinSimvastatinNorthStar Rx LLCANDACurrent
16714-685SimvastatinSimvastatinNorthStar Rx LLCANDACurrent
16714-685SimvastatinSimvastatinNorthStar Rx LLCANDACurrent
16714-685SimvastatinSimvastatinNorthStar Rx LLCANDACurrent
16714-685SimvastatinSimvastatinNorthStar Rx LLCANDACurrent
16714-685SimvastatinSimvastatinNorthStar Rx LLCANDACurrent
43353-007SimvastatinSimvastatinAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-007SimvastatinSimvastatinAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-856SimvastatinSimvastatinAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-856SimvastatinSimvastatinAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-858SimvastatinSimvastatinAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-858SimvastatinSimvastatinAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-860SimvastatinSimvastatinAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-861SimvastatinSimvastatinAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-861SimvastatinSimvastatinAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-875SimvastatinSimvastatinAphena Pharma Solutions - Tennessee, LLCANDACurrent
48433-311SimvastatinSimvastatinSafecor Health, LLCANDACurrent
50090-3473SimvastatinSimvastatinA-S Medication SolutionsANDACurrent
50090-3473SimvastatinSimvastatinA-S Medication SolutionsANDACurrent
50090-4801SimvastatinSimvastatinA-S Medication SolutionsANDACurrent
50090-5019SimvastatinSimvastatinA-S Medication SolutionsANDACurrent
50268-712SimvastatinSimvastatinAvPAKANDACurrent
50268-712SimvastatinSimvastatinAvPAKANDACurrent
50268-713SimvastatinSimvastatinAvPAKANDACurrent
50268-714SimvastatinSimvastatinAvPAKANDACurrent
50268-714SimvastatinSimvastatinAvPAKANDACurrent
50268-715SimvastatinSimvastatinAvPAKANDACurrent
50268-716SimvastatinSimvastatinAvPAKANDACurrent
50268-716SimvastatinSimvastatinAvPAKANDACurrent
50268-716SimvastatinSimvastatinAvPAKANDACurrent
50268-716SimvastatinSimvastatinAvPAKANDACurrent
52343-021SimvastatinSimvastatinACETRIS HEALTH, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
23883ORIG2011-05-26