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#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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