FDA.reportPublic FDA data

Application 213182

Type
NDA
Sponsor
NOVO NORDISK INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RYBELSUSSEMAGLUTIDETABLET;ORAL3MGYesNo
002RYBELSUSSEMAGLUTIDETABLET;ORAL7MGYesNo

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 ยท 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OzempicSEMAGLUTIDEA-S Medication Solutions42bdd912-2393-44c4-b7e0-47672ca289912026-07-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SEMAGLUTIDE
OZEMPICORAL SEMAGLUTIDENovo Nordisk Pharmaceutical Industries, LP27f15fac-7d98-4114-a2ec-92494a91da982026-01-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: RYBELSUS
WEGOVYSEMAGLUTIDEA-S Medication Solutionsf5e548d0-cc79-4c34-a3f5-e20a5b8b65642024-04-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SEMAGLUTIDE
OzempicSEMAGLUTIDEA-S Medication Solutions979e4df4-0597-48ea-b51c-0f699fa6d1662023-11-22Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SEMAGLUTIDE
OZEMPICSEMAGLUTIDEA-S Medication Solutionse6da837c-0da0-41d6-973c-5559bf7643672023-11-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SEMAGLUTIDE

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
63744ORIG2020-06-29
61602ORIG2020-01-17
61590ORIG2020-01-17
61589ORIG2020-01-17