FDA.reportPublic FDA data

Application 220314

Type
ANDA
Sponsor
APOTEX INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SEMAGLUTIDESEMAGLUTIDEINJECTION;SOLUTION2MG/3MLNoNo
002SEMAGLUTIDESEMAGLUTIDEINJECTION;SOLUTION4MG/3MLNoNo
003SEMAGLUTIDESEMAGLUTIDEINJECTION;SOLUTION8MG/3MLNoNo

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 4 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
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