FDA.reportPublic FDA data

Application 210910

Type
NDA
Sponsor
REDHILL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AEMCOLORIFAMYCIN SODIUMTABLET, DELAYED RELEASE;ORALEQ 194MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
57841-1200AemcoloRifamycinRedHill Biopharma LtdNDACurrent
57841-1200AemcoloRifamycinRedHill Biopharma LtdNDACurrent
57841-1201AemcoloRifamycinRedHill Biopharma LtdNDACurrent
57841-1201AemcoloRifamycinRedHill Biopharma LtdNDACurrent
71068-001AemcoloRifamycinAries Pharmaceuticals IncNDACurrent
71068-001AemcoloRifamycinAries Pharmaceuticals IncNDACurrent
71068-001AemcoloRifamycinAries Pharmaceuticals IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
59331SUPPL2019-07-15
56983ORIG2018-12-21
56517ORIG2018-11-20
56503ORIG2018-11-19