Application 090022

Type
ANDA
Sponsor
SUN PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ALENDRONATE SODIUMALENDRONATE SODIUMTABLET;ORALEQ 5MG BASENoNo
002ALENDRONATE SODIUMALENDRONATE SODIUMTABLET;ORALEQ 10MG BASENoNo
003ALENDRONATE SODIUMALENDRONATE SODIUMTABLET;ORALEQ 35MG BASENoNo
004ALENDRONATE SODIUMALENDRONATE SODIUMTABLET;ORALEQ 70MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-1802Alendronate SodiumAlendronate SodiumA-S Medication SolutionsANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44414ORIG2008-09-19