FDA.reportPublic FDA data

Application 090647

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TENOFOVIR DISOPROXIL FUMARATETENOFOVIR DISOPROXIL FUMARATETABLET;ORAL150MGNoNo
002TENOFOVIR DISOPROXIL FUMARATETENOFOVIR DISOPROXIL FUMARATETABLET;ORAL200MGNoNo
003TENOFOVIR DISOPROXIL FUMARATETENOFOVIR DISOPROXIL FUMARATETABLET;ORAL250MGNoNo
004TENOFOVIR DISOPROXIL FUMARATETENOFOVIR DISOPROXIL FUMARATETABLET;ORAL300MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60687-366Tenofovir Disoproxil FumarateTenofovir Disoproxil FumarateAmerican Health PackagingANDACurrent
60687-366Tenofovir Disoproxil FumarateTenofovir Disoproxil FumarateAmerican Health PackagingANDACurrent
60687-366Tenofovir Disoproxil FumarateTenofovir Disoproxil FumarateAmerican Health PackagingANDACurrent
65862-421Tenofovir Disoproxil FumarateTenofovir Disoproxil FumarateAurobindo Pharma LimitedANDACurrent
65862-421Tenofovir Disoproxil FumarateTenofovir Disoproxil FumarateAurobindo Pharma LimitedANDACurrent
65862-421Tenofovir Disoproxil FumarateTenofovir Disoproxil FumarateAurobindo Pharma LimitedANDACurrent
65862-421Tenofovir Disoproxil FumarateTenofovir Disoproxil FumarateAurobindo Pharma LimitedANDACurrent
65862-421Tenofovir Disoproxil FumarateTenofovir Disoproxil FumarateAurobindo Pharma LimitedANDACurrent
65862-818Tenofovir Disoproxil FumarateTenofovir Disoproxil FumarateAurobindo Pharma LimitedANDACurrent
65862-818Tenofovir Disoproxil FumarateTenofovir Disoproxil FumarateAurobindo Pharma LimitedANDACurrent
65862-818Tenofovir Disoproxil FumarateTenofovir Disoproxil FumarateAurobindo Pharma LimitedANDACurrent
65862-818Tenofovir Disoproxil FumarateTenofovir Disoproxil FumarateAurobindo Pharma LimitedANDACurrent
65862-818Tenofovir Disoproxil FumarateTenofovir Disoproxil FumarateAurobindo Pharma LimitedANDACurrent
65862-819Tenofovir Disoproxil FumarateTenofovir Disoproxil FumarateAurobindo Pharma LimitedANDACurrent
65862-819Tenofovir Disoproxil FumarateTenofovir Disoproxil FumarateAurobindo Pharma LimitedANDACurrent
65862-819Tenofovir Disoproxil FumarateTenofovir Disoproxil FumarateAurobindo Pharma LimitedANDACurrent
65862-819Tenofovir Disoproxil FumarateTenofovir Disoproxil FumarateAurobindo Pharma LimitedANDACurrent
65862-819Tenofovir Disoproxil FumarateTenofovir Disoproxil FumarateAurobindo Pharma LimitedANDACurrent
65862-820Tenofovir Disoproxil FumarateTenofovir Disoproxil FumarateAurobindo Pharma LimitedANDACurrent
65862-820Tenofovir Disoproxil FumarateTenofovir Disoproxil FumarateAurobindo Pharma LimitedANDACurrent
65862-820Tenofovir Disoproxil FumarateTenofovir Disoproxil FumarateAurobindo Pharma LimitedANDACurrent
65862-820Tenofovir Disoproxil FumarateTenofovir Disoproxil FumarateAurobindo Pharma LimitedANDACurrent
65862-820Tenofovir Disoproxil FumarateTenofovir Disoproxil FumarateAurobindo Pharma LimitedANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
52552ORIG2018-02-09
9283ORIG2009-02-23