Drug application
RELUGOLIX, ESTRADIOL AND NORETHINDRONE ACETATE (RELUGOLIX, ESTRADIOL, NORETHINDRONE ACETATE)
Drugs@FDA ANDA 220123 · ANNORA PHARMA PRIVATE LIMITED
Key facts
| Drug name | RELUGOLIX, ESTRADIOL AND NORETHINDRONE ACETATE |
|---|---|
| Active ingredients | RELUGOLIX, ESTRADIOL, NORETHINDRONE ACETATE |
| Application type | ANDA |
| Application number | 220123 |
| Company | ANNORA PHARMA PRIVATE LIMITED |
| Dosage forms | TABLET |
| Strength | 40MG, 1MG, 0.5MG |
| Marketing status | None (Tentative Approval) |
| Reference listed drug | No |
| Latest submission status date | Jul 15, 2026 |
At a glance
- 1–9 Submissions
- None Label versions
- None Products
- None Therapeutic equivalents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Drugs@FDA applications
Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.