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Application 078470

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ACARBOSEACARBOSETABLET;ORAL25MGNoNo
002ACARBOSEACARBOSETABLET;ORAL50MGNoNo
003ACARBOSEACARBOSETABLET;ORAL100MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-0140AcarboseAcarboseWest-Ward Pharmaceuticals Inc.ANDACurrent
0054-0140AcarboseAcarboseWest-Ward Pharmaceuticals CorpANDACurrent
0054-0141AcarboseAcarboseWest-Ward Pharmaceuticals CorpANDACurrent
0054-0141AcarboseAcarboseWest-Ward Pharmaceuticals Inc.ANDACurrent
0054-0142AcarboseAcarboseWest-Ward Pharmaceuticals CorpANDACurrent
0054-0142AcarboseAcarboseWest-Ward Pharmaceuticals Inc.ANDACurrent
55289-171AcarboseAcarbosePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-131AcarboseAcarbosePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-131AcarboseAcarbosePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-131AcarboseAcarbosePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-131AcarboseAcarbosePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-131AcarboseAcarbosePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-132AcarboseAcarbosePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-132AcarboseAcarbosePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-132AcarboseAcarbosePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-132AcarboseAcarbosePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-132AcarboseAcarbosePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-133AcarboseAcarbosePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-133AcarboseAcarbosePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-133AcarboseAcarbosePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-133AcarboseAcarbosePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-133AcarboseAcarbosePD-Rx Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9158ORIG2008-05-09