FDA.reportPublic FDA data

Application 090094

Type
ANDA
Sponsor
AUROBINDO PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DIDANOSINEDIDANOSINECAPSULE, DELAYED REL PELLETS;ORAL125MGNoNo
002DIDANOSINEDIDANOSINECAPSULE, DELAYED REL PELLETS;ORAL200MGNoNo
003DIDANOSINEDIDANOSINECAPSULE, DELAYED REL PELLETS;ORAL250MGNoNo
004DIDANOSINEDIDANOSINECAPSULE, DELAYED REL PELLETS;ORAL400MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
65862-310DidanosineDidanosineAurobindo Pharma LimitedANDACurrent
65862-310DidanosineDidanosineAurobindo Pharma LimitedANDACurrent
65862-311DidanosineDidanosineAurobindo Pharma LimitedANDACurrent
65862-311DidanosineDidanosineAurobindo Pharma LimitedANDACurrent
65862-312DidanosineDidanosineAurobindo Pharma LimitedANDACurrent
65862-312DidanosineDidanosineAurobindo Pharma LimitedANDACurrent
65862-313DidanosineDidanosineAurobindo Pharma LimitedANDACurrent
65862-313DidanosineDidanosineAurobindo Pharma LimitedANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
23936ORIG2008-11-13
31450ORIG2008-09-26