FDA.reportPublic FDA data

Application 077672

Type
ANDA
Sponsor
AUROBINDO PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001STAVUDINESTAVUDINECAPSULE;ORAL30MGNoNo
002STAVUDINESTAVUDINECAPSULE;ORAL40MGNoNo
003STAVUDINESTAVUDINECAPSULE;ORAL15MGNoNo
004STAVUDINESTAVUDINECAPSULE;ORAL20MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
57237-234StavudineStavudineCitron Pharma LLCANDACurrent
57237-235StavudineStavudineCitron Pharma LLCANDACurrent
57237-236StavudineStavudineCitron Pharma LLCANDACurrent
57237-237StavudineStavudineCitron Pharma LLCANDACurrent
64980-354StavudineStavudineRising Pharmaceuticals, Inc.ANDACurrent
64980-354StavudineStavudineRising Pharmaceuticals, Inc.ANDACurrent
64980-355StavudineStavudineRising Pharmaceuticals, Inc.ANDACurrent
64980-355StavudineStavudineRising Pharmaceuticals, Inc.ANDACurrent
64980-356StavudineStavudineRising Pharmaceuticals, Inc.ANDACurrent
64980-356StavudineStavudineRising Pharmaceuticals, Inc.ANDACurrent
64980-357StavudineStavudineRising Pharmaceuticals, Inc.ANDACurrent
64980-357StavudineStavudineRising Pharmaceuticals, Inc.ANDACurrent
65862-046StavudineStavudineAurobindo Pharma LimitedANDACurrent
65862-046StavudineStavudineAurobindo Pharma LimitedANDACurrent
65862-047StavudineStavudineAurobindo Pharma LimitedANDACurrent
65862-047StavudineStavudineAurobindo Pharma LimitedANDACurrent
65862-111StavudineStavudineAurobindo Pharma LimitedANDACurrent
65862-111StavudineStavudineAurobindo Pharma LimitedANDACurrent
65862-112StavudineStavudineAurobindo Pharma LimitedANDACurrent
65862-112StavudineStavudineAurobindo Pharma LimitedANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
18468ORIG2009-02-04
31275ORIG2008-12-30
31274ORIG2006-07-03
31273ORIG2005-07-08