FDA.reportPublic FDA data

Application 090124

Type
ANDA
Sponsor
AUROBINDO PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ALENDRONATE SODIUMALENDRONATE SODIUMTABLET;ORALEQ 10MG BASENoNo
002ALENDRONATE SODIUMALENDRONATE SODIUMTABLET;ORALEQ 35MG BASENoNo
003ALENDRONATE SODIUMALENDRONATE SODIUMTABLET;ORALEQ 70MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16714-631Alendronate SodiumAlendronate SodiumNorthStar Rx LLCANDACurrent
16714-631Alendronate SodiumAlendronate SodiumNorthStar Rx LLCANDACurrent
16714-631Alendronate SodiumAlendronate SodiumNorthStar Rx LLCANDACurrent
16714-632Alendronate SodiumAlendronate SodiumNorthStar Rx LLCANDACurrent
16714-632Alendronate SodiumAlendronate SodiumNorthStar Rx LLCANDACurrent
16714-632Alendronate SodiumAlendronate SodiumNorthStar Rx LLCANDACurrent
16714-633Alendronate SodiumAlendronate SodiumNorthStar Rx LLCANDACurrent
16714-633Alendronate SodiumAlendronate SodiumNorthStar Rx LLCANDACurrent
16714-633Alendronate SodiumAlendronate SodiumNorthStar Rx LLCANDACurrent
50090-2322Alendronate SodiumAlendronate SodiumA-S Medication SolutionsANDACurrent
50090-2322Alendronate SodiumAlendronate SodiumA-S Medication SolutionsANDACurrent
50090-2322Alendronate SodiumAlendronate SodiumA-S Medication SolutionsANDACurrent
50090-2322Alendronate SodiumAlendronate SodiumA-S Medication SolutionsANDACurrent
50090-3126Alendronate SodiumAlendronate SodiumA-S Medication SolutionsANDACurrent
50090-3126Alendronate SodiumAlendronate SodiumA-S Medication SolutionsANDACurrent
50090-3126Alendronate SodiumAlendronate SodiumA-S Medication SolutionsANDACurrent
50090-5474Alendronate SodiumAlendronate SodiumA-S Medication SolutionsANDACurrent
50090-5677Alendronate SodiumAlendronate SodiumA-S Medication SolutionsANDACurrent
50090-5677Alendronate SodiumAlendronate SodiumA-S Medication SolutionsANDACurrent
64980-340Alendronate SodiumAlendronate SodiumRising Pharmaceuticals, Inc.ANDACurrent
64980-340Alendronate SodiumAlendronate SodiumRising Pharmaceuticals, Inc.ANDACurrent
64980-340Alendronate SodiumAlendronate SodiumRising Pharmaceuticals, Inc.ANDACurrent
64980-341Alendronate SodiumAlendronate SodiumRising Pharmaceuticals, Inc.ANDACurrent
64980-341Alendronate SodiumAlendronate SodiumRising Pharmaceuticals, Inc.ANDACurrent
64980-341Alendronate SodiumAlendronate SodiumRising Pharmaceuticals, Inc.ANDACurrent
64980-342Alendronate SodiumAlendronate SodiumRising Pharmaceuticals, Inc.ANDACurrent
64980-342Alendronate SodiumAlendronate SodiumRising Pharmaceuticals, Inc.ANDACurrent
64980-342Alendronate SodiumAlendronate SodiumRising Pharmaceuticals, Inc.ANDACurrent
65862-327Alendronate SodiumAlendronate SodiumAurobindo Pharma LimitedANDACurrent
65862-327Alendronate SodiumAlendronate SodiumAurobindo Pharma LimitedANDACurrent
65862-327Alendronate SodiumAlendronate SodiumAurobindo Pharma LimitedANDACurrent
65862-327Alendronate SodiumAlendronate SodiumAurobindo Pharma LimitedANDACurrent
65862-328Alendronate SodiumAlendronate SodiumAurobindo Pharma LimitedANDACurrent
65862-328Alendronate SodiumAlendronate SodiumAurobindo Pharma LimitedANDACurrent
65862-328Alendronate SodiumAlendronate SodiumAurobindo Pharma LimitedANDACurrent
65862-328Alendronate SodiumAlendronate SodiumAurobindo Pharma LimitedANDACurrent
65862-329Alendronate SodiumAlendronate SodiumAurobindo Pharma LimitedANDACurrent
65862-329Alendronate SodiumAlendronate SodiumAurobindo Pharma LimitedANDACurrent
65862-329Alendronate SodiumAlendronate SodiumAurobindo Pharma LimitedANDACurrent
65862-329Alendronate SodiumAlendronate SodiumAurobindo Pharma LimitedANDACurrent
68071-1514Alendronate SodiumAlendronate SodiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1514Alendronate SodiumAlendronate SodiumNuCare Pharmaceuticals,Inc.ANDACurrent
68788-8235Alendronate SodiumAlendronate SodiumPreferred Pharmaceuticals, Inc.ANDACurrent
71205-048Alendronate SodiumAlendronate SodiumProficient Rx LPANDACurrent
71205-048Alendronate SodiumAlendronate SodiumProficient Rx LPANDACurrent
71205-048Alendronate SodiumAlendronate SodiumProficient Rx LPANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44415ORIG2008-09-19