FDA.reportPublic FDA data

Application 021497

Type
NDA
Sponsor
ROMARK

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ALINIANITAZOXANIDETABLET;ORAL500MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43386-405N/AnitazoxanideLupin Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
43386-405N/AnitazoxanideLupin Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
67546-111AlinianitazoxanideRomark Laboratories, L.C.NDACurrent
67546-111AlinianitazoxanideRomark Laboratories, L.C.NDACurrent
67546-111AlinianitazoxanideRomark Laboratories, L.C.NDACurrent
67546-111AlinianitazoxanideRomark Laboratories, L.C.NDACurrent
67546-111AlinianitazoxanideRomark Laboratories, L.C.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
69933SUPPL2022-01-20
69700SUPPL2021-12-21
69620SUPPL2021-12-17
15601SUPPL2016-07-13
27932SUPPL2016-07-12
42193ORIG2004-10-08
15600ORIG2004-07-21
5544ORIG2004-07-21