Application 021103
- Type
- NDA
- Sponsor
- NOVO NORDISK
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ACTIVELLA | ESTRADIOL; NORETHINDRONE ACETATE | TABLET; ORAL | 1MG/0.5MG | No | No |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Activella | ESTRADIOL/NORETHINDRONE ACETATE | Amneal Pharmaceuticals LLC | d4b0c1dd-aae9-4ca2-958c-71dbe5d0fab0 | 2023-11-30 | Boxed warning, Warnings, Adverse reactions | Activella |