FDA.reportPublic FDA data

Application 021431

Type
NDA
Sponsor
FOREST LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CAMPRALACAMPROSATE CALCIUMTABLET, DELAYED RELEASE;ORAL333MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68151-4760Campralacamprosate calciumCarilion Materials ManagementNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
27754SUPPL2012-02-01
15448SUPPL2012-01-30
27753SUPPL2010-12-15
36903SUPPL2010-12-13
42155ORIG2004-10-18
36902ORIG2004-07-30
27752ORIG2004-07-30