FDA.reportPublic FDA data

Application 077237

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZALEPLONZALEPLONCAPSULE;ORAL5MGNoNo
002ZALEPLONZALEPLONCAPSULE;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-0084ZaleplonZaleplonWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0084ZaleplonZaleplonWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0084ZaleplonZaleplonWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0085ZaleplonZaleplonWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0085ZaleplonZaleplonWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0085ZaleplonZaleplonWest-Ward Pharmaceuticals Corp.ANDACurrent
43063-912ZaleplonZaleplonPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-912ZaleplonZaleplonPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-912ZaleplonZaleplonPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-912ZaleplonZaleplonPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-912ZaleplonZaleplonPD-Rx Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44347ORIG2008-07-01
31208ORIG2005-11-18