Application 213388
- Type
- NDA
- Sponsor
- ABBVIE INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ORIAHNN | ELAGOLIX;ESTRADIOL NORETHINDRONE ACETATE;ELAGOLIX | CAPSULE;ORAL | 300MG;1MG,0.5MG;300MG | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0074-1017 | Oriahnn | Elagolix and Estradiol and Norethisterone | AbbVie Inc. | NDA | Current |
| 0074-1017 | Oriahnn | Elagolix and Estradiol and Norethisterone | AbbVie Inc. | NDA | Current |
| 0074-1017 | Oriahnn | Elagolix and Estradiol and Norethisterone | AbbVie Inc. | NDA | Current |
| 0074-1017 | Oriahnn | Elagolix and Estradiol and Norethisterone | AbbVie Inc. | NDA | Current |
| 0074-1017 | Oriahnn | Elagolix and Estradiol and Norethisterone | AbbVie Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 85844 | SUPPL | 2026-05-07 |
| 84466 | SUPPL | 2025-12-19 |
| 79890 | SUPPL | 2024-10-15 |
| 79884 | SUPPL | 2024-10-15 |
| 74444 | SUPPL | 2023-06-06 |
| 74440 | SUPPL | 2023-06-06 |
| 74439 | SUPPL | 2023-06-06 |
| 68389 | SUPPL | 2021-08-17 |
| 68276 | SUPPL | 2021-08-03 |
| 68275 | SUPPL | 2021-08-03 |
| 65154 | ORIG | 2020-11-04 |
| 63387 | ORIG | 2020-06-02 |
| 63377 | ORIG | 2020-06-02 |
| 63376 | ORIG | 2020-06-02 |