FDA.reportPublic FDA data

Application 021498

Type
NDA
Sponsor
ROMARK

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ALINIANITAZOXANIDEFOR SUSPENSION;ORAL100MG/5MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
67546-212AlinianitazoxanideRomark Laboratories, L.C.NDACurrent
67546-212AlinianitazoxanideRomark Laboratories, L.C.NDACurrent
67546-212AlinianitazoxanideRomark Laboratories, L.C.NDACurrent
67546-212AlinianitazoxanideRomark Laboratories, L.C.NDACurrent
67546-212AlinianitazoxanideRomark Laboratories, L.C.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
69934SUPPL2022-01-20
37076SUPPL2016-07-13
5547SUPPL2016-07-12
21697SUPPL2007-10-02
5546SUPPL2005-06-21
37075SUPPL2005-06-16
21696SUPPL2004-10-08
37074SUPPL2004-07-21
5545SUPPL2004-07-21
21695ORIG2003-04-25
27933ORIG2002-11-22
15602ORIG2002-11-22