FDA.reportPublic FDA data

Application 076984

Type
ANDA
Sponsor
WATSON LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ALENDRONATE SODIUMALENDRONATE SODIUMTABLET;ORALEQ 35MG BASENoNo
002ALENDRONATE SODIUMALENDRONATE SODIUMTABLET;ORALEQ 40MG BASENoNo
003ALENDRONATE SODIUMALENDRONATE SODIUMTABLET;ORALEQ 70MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16252-599alendronate sodiumalendronate sodiumActavis Pharma, Inc.ANDACurrent
16252-601alendronate sodiumalendronate sodiumActavis Pharma, Inc.ANDACurrent
50090-1091alendronate sodiumalendronate sodiumA-S Medication SolutionsANDACurrent
53217-321alendronate sodiumalendronate sodiumAidarex Pharmaceuticals LLCANDACurrent
55695-012alendronate sodiumalendronate sodiumDepartment of State Health Services, Pharmacy BranchANDACurrent
63187-580alendronate sodiumalendronate sodiumProficient Rx LPANDACurrent
68071-4120alendronate sodiumalendronate sodiumNuCare Pharmaceuticals,Inc.ANDACurrent
68258-3014Alendronate Sodiumalendronate sodiumDispensing Solutions Inc.ANDACurrent
70518-0269alendronate sodiumalendronate sodiumREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
23844ORIG2008-09-19