FDA.reportPublic FDA data

Application 076768

Type
ANDA
Sponsor
CIPLA

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
21695-901Alendronate Sodiumalendronate sodiumRebel Distributors CorpANDACurrent
21695-902Alendronate Sodiumalendronate sodiumRebel Distributors CorpANDACurrent
50090-4076ALENDRONATE SODIUMAlendronate sodiumA-S Medication SolutionsANDACurrent
50090-4076ALENDRONATE SODIUMAlendronate sodiumA-S Medication SolutionsANDACurrent
50090-4692ALENDRONATE SODIUMAlendronate sodiumA-S Medication SolutionsANDACurrent
50090-4692ALENDRONATE SODIUMAlendronate sodiumA-S Medication SolutionsANDACurrent
50090-4692ALENDRONATE SODIUMAlendronate sodiumA-S Medication SolutionsANDACurrent
50090-4692ALENDRONATE SODIUMAlendronate sodiumA-S Medication SolutionsANDACurrent
61919-689ALENDRONATE SODIUMALENDRONATE SODIUMDIRECT RXANDACurrent
61919-729Alendronate SodiumAlendronate SodiumDirect_RxANDACurrent
68071-3171ALENDRONATE SODIUMAlendronate sodiumNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3171ALENDRONATE SODIUMAlendronate sodiumNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3171ALENDRONATE SODIUMAlendronate sodiumNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3340ALENDRONATE SODIUMAlendronate sodiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3340ALENDRONATE SODIUMAlendronate sodiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3340ALENDRONATE SODIUMAlendronate sodiumNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7130ALENDRONATE SODIUMAlendronate sodiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-7130ALENDRONATE SODIUMAlendronate sodiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-7130ALENDRONATE SODIUMAlendronate sodiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-7130ALENDRONATE SODIUMAlendronate sodiumPreferred Pharmaceuticals Inc.ANDACurrent
69097-223ALENDRONATE SODIUMAlendronate sodiumCipla USA Inc.ANDACurrent
69097-223ALENDRONATE SODIUMAlendronate sodiumCipla USA Inc.ANDACurrent
69097-223ALENDRONATE SODIUMAlendronate sodiumCipla USA Inc.ANDACurrent
69097-224ALENDRONATE SODIUMAlendronate sodiumCipla USA Inc.ANDACurrent
69097-224ALENDRONATE SODIUMAlendronate sodiumCipla USA Inc.ANDACurrent
69097-224ALENDRONATE SODIUMAlendronate sodiumCipla USA Inc.ANDACurrent
70518-0033ALENDRONATE SODIUMAlendronate sodiumREMEDYREPACK INC.ANDACurrent
70518-0033ALENDRONATE SODIUMAlendronate sodiumREMEDYREPACK INC.ANDACurrent
70518-0033ALENDRONATE SODIUMAlendronate sodiumREMEDYREPACK INC.ANDACurrent
70518-0033ALENDRONATE SODIUMAlendronate sodiumREMEDYREPACK INC.ANDACurrent
70518-0033ALENDRONATE SODIUMAlendronate sodiumREMEDYREPACK INC.ANDACurrent
70518-0033ALENDRONATE SODIUMAlendronate sodiumREMEDYREPACK INC.ANDACurrent
70518-0033ALENDRONATE SODIUMAlendronate sodiumREMEDYREPACK INC.ANDACurrent
70518-0033ALENDRONATE SODIUMAlendronate sodiumREMEDYREPACK INC.ANDACurrent
70518-0033ALENDRONATE SODIUMAlendronate sodiumREMEDYREPACK INC.ANDACurrent
70518-0033ALENDRONATE SODIUMAlendronate sodiumREMEDYREPACK INC.ANDACurrent
70518-0033ALENDRONATE SODIUMAlendronate sodiumREMEDYREPACK INC.ANDACurrent
76282-681ALENDRONATE SODIUMAlendronate sodiumExelan Pharmaceuticals Inc.ANDACurrent
76282-682ALENDRONATE SODIUMAlendronate sodiumExelan Pharmaceuticals Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44320ORIG2008-09-19