Application 213378
- Type
- NDA
- Sponsor
- ALKERMES INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LYBALVI | OLANZAPINE; SAMIDORPHAN | TABLET; ORAL | 5MG; 10MG | Yes | No |
| 002 | LYBALVI | OLANZAPINE; SAMIDORPHAN | TABLET; ORAL | 10MG; 10MG | Yes | No |
| 003 | LYBALVI | OLANZAPINE; SAMIDORPHAN | TABLET; ORAL | 15MG; 20MG | Yes | No |
| 004 | LYBALVI | OLANZAPINE; SAMIDORPHAN | TABLET; ORAL | 20MG; 10MG | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 65757-651 | LYBALVI | olanzapine and samidorphan L-malate | Alkermes, Inc. | NDA | Current |
| 65757-651 | LYBALVI | olanzapine and samidorphan L-malate | Alkermes, Inc. | NDA | Current |
| 65757-652 | LYBALVI | olanzapine and samidorphan L-malate | Alkermes, Inc. | NDA | Current |
| 65757-652 | LYBALVI | olanzapine and samidorphan L-malate | Alkermes, Inc. | NDA | Current |
| 65757-653 | LYBALVI | olanzapine and samidorphan L-malate | Alkermes, Inc. | NDA | Current |
| 65757-653 | LYBALVI | olanzapine and samidorphan L-malate | Alkermes, Inc. | NDA | Current |
| 65757-654 | LYBALVI | olanzapine and samidorphan L-malate | Alkermes, Inc. | NDA | Current |
| 65757-654 | LYBALVI | olanzapine and samidorphan L-malate | Alkermes, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 84947 | SUPPL | 2026-02-05 |
| 84896 | SUPPL | 2026-02-03 |
| 81424 | SUPPL | 2025-03-04 |
| 81403 | SUPPL | 2025-03-03 |
| 81402 | SUPPL | 2025-03-03 |
| 81162 | SUPPL | 2025-02-07 |
| 81027 | SUPPL | 2025-02-05 |
| 77362 | SUPPL | 2024-01-31 |
| 77360 | SUPPL | 2024-01-31 |
| 75566 | SUPPL | 2023-09-26 |
| 75565 | SUPPL | 2023-09-26 |
| 67904 | ORIG | 2021-06-25 |
| 67903 | ORIG | 2021-06-25 |
| 67641 | ORIG | 2021-06-01 |
| 67640 | ORIG | 2021-06-01 |
| 67639 | ORIG | 2021-06-01 |
| 67638 | ORIG | 2021-06-01 |
| 67637 | ORIG | 2021-06-01 |