FDA.reportPublic FDA data

Application 208232

Type
NDA
Sponsor
CHIASMA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MYCAPSSAOCTREOTIDECAPSULE, DELAYED RELEASE; ORAL20MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
69880-120MycapssaOctreotideAmryt Pharmaceuticals Designated Activity CompanyNDACurrent
69880-120MycapssaOctreotideChiasma Inc.NDACurrent
69880-120MycapssaOctreotideChiasma Inc.NDACurrent
69880-120MycapssaOctreotideChiasma Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79091SUPPL 2024-07-15
79068SUPPL 2024-07-15
66746ORIG2021-03-11
63836ORIG2020-07-09
63753ORIG2020-06-30