Application 217650
- Type
- ANDA
- Sponsor
- TEVA PHARM
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | SHEUR | ELAGOLIX, ESTRADIOL AND NORETHINDRONE ACETATE AND ELAGOLIX | CAPSULE | 300MG/1MG/0.5MG | No | No |
Source provenance: Browse the complete Orange Book source catalog.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 83420 | ORIG | 2025-09-23 |