FDA.reportPublic FDA data

Application 202229

Type
ANDA
Sponsor
GLENMARK GENERICS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ACAMPROSATE CALCIUMACAMPROSATE CALCIUMTABLET, DELAYED RELEASE;ORAL333MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-7213Acamprosate CalciumAcamprosate CalciumMajor PharmaceuticalsANDACurrent
10135-636Acamprosate CalciumAcamprosate CalciumMarlex Pharmaceuticals IncANDACurrent
10135-636Acamprosate CalciumAcamprosate CalciumMarlex Pharmaceuticals IncANDACurrent
60687-121Acamprosate CalciumAcamprosate CalciumAmerican Health PackagingANDACurrent
60687-121Acamprosate CalciumAcamprosate CalciumAmerican Health PackagingANDACurrent
60687-121Acamprosate CalciumAcamprosate CalciumAmerican Health PackagingANDACurrent
60687-121Acamprosate CalciumAcamprosate CalciumAmerican Health PackagingANDACurrent
68462-435Acamprosate CalciumAcamprosate CalciumGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-435Acamprosate CalciumAcamprosate CalciumGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-435Acamprosate CalciumAcamprosate CalciumGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-435Acamprosate CalciumAcamprosate CalciumGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-435Acamprosate CalciumAcamprosate CalciumGlenmark Pharmaceuticals Inc., USAANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
32209ORIG2013-07-18