FDA.reportPublic FDA data

Application 075710

Type
ANDA
Sponsor
IMPAX LABS INC

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 40MG BASENoNo
005ALENDRONATE SODIUMALENDRONATE SODIUMTABLET;ORALEQ 70MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0115-1676Alendronate SodiumAlendronate SodiumAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1676Alendronate SodiumAlendronate SodiumImpax GenericsANDACurrent
0115-1676Alendronate SodiumAlendronate SodiumAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1676Alendronate SodiumAlendronate SodiumAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1678Alendronate SodiumAlendronate SodiumAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1678Alendronate SodiumAlendronate SodiumAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1678Alendronate SodiumAlendronate SodiumImpax GenericsANDACurrent
0115-1678Alendronate SodiumAlendronate SodiumAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1679Alendronate SodiumAlendronate SodiumAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1679Alendronate SodiumAlendronate SodiumAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1679Alendronate SodiumAlendronate SodiumImpax GenericsANDACurrent
0115-1679Alendronate SodiumAlendronate SodiumAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1680Alendronate SodiumAlendronate SodiumAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1680Alendronate SodiumAlendronate SodiumAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1680Alendronate SodiumAlendronate SodiumImpax GenericsANDACurrent
0115-1680Alendronate SodiumAlendronate SodiumAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1681Alendronate SodiumAlendronate SodiumAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1681Alendronate SodiumAlendronate SodiumAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1681Alendronate SodiumAlendronate SodiumImpax GenericsANDACurrent
0115-1681Alendronate SodiumAlendronate SodiumAmneal Pharmaceuticals of New York LLCANDACurrent
33261-554Alendronate SodiumAlendronate SodiumAidarex Pharmaceuticals LLCANDACurrent
33261-820Alendronate SodiumAlendronate SodiumAidarex Pharmaceuticals LLCANDACurrent
33261-993Alendronate SodiumAlendronate SodiumAidarex Pharmaceuticals LLCANDACurrent
63187-175Alendronate SodiumAlendronate SodiumProficient Rx LPANDACurrent
66116-428Alendronate SodiumAlendronate SodiumMedVantx, Inc.ANDACurrent
68788-7393Alendronate SodiumAlendronate SodiumPreferred Pharmaceuticals Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
43021ORIG2012-03-30
23771ORIG2008-02-28
8773ORIG2008-02-07