Application 217690
- Type
- ANDA
- Sponsor
- HETERO LABS LIMITED
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 002 | ELAGOLIX | ELAGOLIX | TABLET | 150MG | 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 |
|---|---|---|---|---|---|---|
| Orilissa | ELAGOLIX | AbbVie Inc. | a86757b3-09c5-fd3b-1223-244e94f50a66 | 2025-12-19 | Warnings, Adverse reactions | ELAGOLIX |