Application 208716
- Type
- NDA
- Sponsor
- ELI LILLY AND CO
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VERZENIO | ABEMACICLIB | TABLET;ORAL | 50MG | Yes | No |
| 002 | VERZENIO | ABEMACICLIB | TABLET;ORAL | 100MG | Yes | No |
| 003 | VERZENIO | ABEMACICLIB | TABLET;ORAL | 150MG | Yes | No |
| 004 | VERZENIO | ABEMACICLIB | TABLET;ORAL | 200MG | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N208716-001 | VERZENIO | ABEMACICLIB | 50MG | TABLET / ORAL | RLD | 2017-09-28 | |
| N208716-002 | VERZENIO | ABEMACICLIB | 100MG | TABLET / ORAL | RLD | 2017-09-28 | |
| N208716-003 | VERZENIO | ABEMACICLIB | 150MG | TABLET / ORAL | RLD | 2017-09-28 | |
| N208716-004 | VERZENIO | ABEMACICLIB | 200MG | TABLET / ORAL | RLD, RS | 2017-09-28 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N208716-001 | 7855211 | 2031-09-28 | U-2135 | Drug substance, Drug product | 2017-10-16 |
| N208716-001 | 7855211 | 2031-09-28 | U-3242 | Drug substance, Drug product | 2017-10-16 |
| N208716-001 | 7855211 | 2031-09-28 | U-3265 | Drug substance, Drug product | 2017-10-16 |
| N208716-001 | 7855211 | 2031-09-28 | U-3546 | Drug substance, Drug product | 2017-10-16 |
| N208716-002 | 7855211 | 2031-09-28 | U-2135 | Drug substance, Drug product | 2017-10-16 |
| N208716-002 | 7855211 | 2031-09-28 | U-3242 | Drug substance, Drug product | 2017-10-16 |
| N208716-002 | 7855211 | 2031-09-28 | U-3265 | Drug substance, Drug product | 2017-10-16 |
| N208716-002 | 7855211 | 2031-09-28 | U-3546 | Drug substance, Drug product | 2017-10-16 |
| N208716-003 | 7855211 | 2031-09-28 | U-2135 | Drug substance, Drug product | 2017-10-16 |
| N208716-003 | 7855211 | 2031-09-28 | U-3242 | Drug substance, Drug product | 2017-10-16 |
| N208716-003 | 7855211 | 2031-09-28 | U-3265 | Drug substance, Drug product | 2017-10-16 |
| N208716-003 | 7855211 | 2031-09-28 | U-3546 | Drug substance, Drug product | 2017-10-16 |
| N208716-004 | 7855211 | 2031-09-28 | U-1981 | Drug substance, Drug product | 2017-10-16 |
| N208716-004 | 7855211 | 2031-09-28 | U-2135 | Drug substance, Drug product | 2017-10-16 |
| N208716-004 | 7855211 | 2031-09-28 | U-3242 | Drug substance, Drug product | 2017-10-16 |
| N208716-004 | 7855211 | 2031-09-28 | U-3265 | Drug substance, Drug product | 2017-10-16 |
| N208716-004 | 7855211 | 2031-09-28 | U-3546 | Drug substance, Drug product | 2017-10-16 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208716-001 | VERZENIO | 50MG | TABLET / ORAL | RLD | 2017-09-28 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208716-002 | VERZENIO | 100MG | TABLET / ORAL | RLD | 2017-09-28 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208716-003 | VERZENIO | 150MG | TABLET / ORAL | RLD | 2017-09-28 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208716-004 | VERZENIO | 200MG | TABLET / ORAL | RLD, RS | 2017-09-28 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N208716-001 | VERZENIO | 50MG | TABLET / ORAL | RLD | 2017-09-28 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N208716-002 | VERZENIO | 100MG | TABLET / ORAL | RLD | 2017-09-28 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N208716-003 | VERZENIO | 150MG | TABLET / ORAL | RLD | 2017-09-28 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N208716-004 | VERZENIO | 200MG | TABLET / ORAL | RLD, RS | 2017-09-28 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N208716-001 | VERZENIO | 50MG | TABLET / ORAL | RLD | 2017-09-28 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N208716-002 | VERZENIO | 100MG | TABLET / ORAL | RLD | 2017-09-28 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N208716-003 | VERZENIO | 150MG | TABLET / ORAL | RLD | 2017-09-28 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N208716-004 | VERZENIO | 200MG | TABLET / ORAL | RLD, RS | 2017-09-28 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N208716-001 | VERZENIO | 50MG | TABLET / ORAL | RLD | 2017-09-28 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N208716-002 | VERZENIO | 100MG | TABLET / ORAL | RLD | 2017-09-28 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N208716-003 | VERZENIO | 150MG | TABLET / ORAL | RLD | 2017-09-28 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N208716-004 | VERZENIO | 200MG | TABLET / ORAL | RLD, RS | 2017-09-28 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N208716-001 | VERZENIO | 50MG | TABLET / ORAL | RLD | 2017-09-28 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N208716-002 | VERZENIO | 100MG | TABLET / ORAL | RLD | 2017-09-28 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N208716-003 | VERZENIO | 150MG | TABLET / ORAL | RLD | 2017-09-28 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N208716-004 | VERZENIO | 200MG | TABLET / ORAL | RLD, RS | 2017-09-28 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N208716-001 | VERZENIO | 50MG | TABLET / ORAL | RLD | 2017-09-28 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N208716-002 | VERZENIO | 100MG | TABLET / ORAL | RLD | 2017-09-28 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N208716-003 | VERZENIO | 150MG | TABLET / ORAL | RLD | 2017-09-28 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N208716-004 | VERZENIO | 200MG | TABLET / ORAL | RLD, RS | 2017-09-28 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N208716-001 | VERZENIO | 50MG | TABLET / ORAL | RLD | 2017-09-28 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N208716-002 | VERZENIO | 100MG | TABLET / ORAL | RLD | 2017-09-28 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N208716-003 | VERZENIO | 150MG | TABLET / ORAL | RLD | 2017-09-28 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N208716-004 | VERZENIO | 200MG | TABLET / ORAL | RLD, RS | 2017-09-28 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N208716-001 | VERZENIO | 50MG | TABLET / ORAL | RLD | 2017-09-28 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N208716-002 | VERZENIO | 100MG | TABLET / ORAL | RLD | 2017-09-28 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N208716-003 | VERZENIO | 150MG | TABLET / ORAL | RLD | 2017-09-28 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N208716-004 | VERZENIO | 200MG | TABLET / ORAL | RLD, RS | 2017-09-28 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N208716-001 | VERZENIO | 50MG | TABLET / ORAL | RLD | 2017-09-28 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N208716-002 | VERZENIO | 100MG | TABLET / ORAL | RLD | 2017-09-28 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N208716-003 | VERZENIO | 150MG | TABLET / ORAL | RLD | 2017-09-28 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N208716-004 | VERZENIO | 200MG | TABLET / ORAL | RLD, RS | 2017-09-28 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N208716-001 | VERZENIO | 50MG | TABLET / ORAL | RLD | 2017-09-28 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N208716-002 | VERZENIO | 100MG | TABLET / ORAL | RLD | 2017-09-28 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N208716-003 | VERZENIO | 150MG | TABLET / ORAL | RLD | 2017-09-28 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N208716-004 | VERZENIO | 200MG | TABLET / ORAL | RLD, RS | 2017-09-28 | 4b0b4de00fa7… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N208716-001 | 7855211 | 2031-09-28 | U-2135 | Drug substance, Drug product | 2017-10-16 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N208716-001 | 7855211 | 2031-09-28 | U-3546 | Drug substance, Drug product | 2017-10-16 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N208716-001 | 7855211 | 2031-09-28 | U-3265 | Drug substance, Drug product | 2017-10-16 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N208716-001 | 7855211 | 2031-09-28 | U-3242 | Drug substance, Drug product | 2017-10-16 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N208716-002 | 7855211 | 2031-09-28 | U-2135 | Drug substance, Drug product | 2017-10-16 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N208716-002 | 7855211 | 2031-09-28 | U-3546 | Drug substance, Drug product | 2017-10-16 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N208716-002 | 7855211 | 2031-09-28 | U-3265 | Drug substance, Drug product | 2017-10-16 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N208716-002 | 7855211 | 2031-09-28 | U-3242 | Drug substance, Drug product | 2017-10-16 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N208716-003 | 7855211 | 2031-09-28 | U-2135 | Drug substance, Drug product | 2017-10-16 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N208716-003 | 7855211 | 2031-09-28 | U-3546 | Drug substance, Drug product | 2017-10-16 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N208716-003 | 7855211 | 2031-09-28 | U-3265 | Drug substance, Drug product | 2017-10-16 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N208716-003 | 7855211 | 2031-09-28 | U-3242 | Drug substance, Drug product | 2017-10-16 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N208716-004 | 7855211 | 2031-09-28 | U-1981 | Drug substance, Drug product | 2017-10-16 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N208716-004 | 7855211 | 2031-09-28 | U-2135 | Drug substance, Drug product | 2017-10-16 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N208716-004 | 7855211 | 2031-09-28 | U-3265 | Drug substance, Drug product | 2017-10-16 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N208716-004 | 7855211 | 2031-09-28 | U-3546 | Drug substance, Drug product | 2017-10-16 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N208716-004 | 7855211 | 2031-09-28 | U-3242 | Drug substance, Drug product | 2017-10-16 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | N208716-001 | 7855211 | 2031-09-28 | U-2135 | Drug substance, Drug product | 2017-10-16 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N208716-001 | 7855211 | 2031-09-28 | U-3546 | Drug substance, Drug product | 2017-10-16 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N208716-001 | 7855211 | 2031-09-28 | U-3265 | Drug substance, Drug product | 2017-10-16 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N208716-001 | 7855211 | 2031-09-28 | U-3242 | Drug substance, Drug product | 2017-10-16 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N208716-002 | 7855211 | 2031-09-28 | U-2135 | Drug substance, Drug product | 2017-10-16 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N208716-002 | 7855211 | 2031-09-28 | U-3546 | Drug substance, Drug product | 2017-10-16 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N208716-002 | 7855211 | 2031-09-28 | U-3265 | Drug substance, Drug product | 2017-10-16 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N208716-002 | 7855211 | 2031-09-28 | U-3242 | Drug substance, Drug product | 2017-10-16 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N208716-003 | 7855211 | 2031-09-28 | U-2135 | Drug substance, Drug product | 2017-10-16 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N208716-003 | 7855211 | 2031-09-28 | U-3546 | Drug substance, Drug product | 2017-10-16 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N208716-003 | 7855211 | 2031-09-28 | U-3265 | Drug substance, Drug product | 2017-10-16 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N208716-003 | 7855211 | 2031-09-28 | U-3242 | Drug substance, Drug product | 2017-10-16 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N208716-004 | 7855211 | 2031-09-28 | U-1981 | Drug substance, Drug product | 2017-10-16 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N208716-004 | 7855211 | 2031-09-28 | U-2135 | Drug substance, Drug product | 2017-10-16 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N208716-004 | 7855211 | 2031-09-28 | U-3265 | Drug substance, Drug product | 2017-10-16 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N208716-004 | 7855211 | 2031-09-28 | U-3546 | Drug substance, Drug product | 2017-10-16 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N208716-004 | 7855211 | 2031-09-28 | U-3242 | Drug substance, Drug product | 2017-10-16 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N208716-001 | 7855211 | 2031-09-28 | U-2135 | Drug substance, Drug product | 2017-10-16 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N208716-001 | 7855211 | 2031-09-28 | U-3546 | Drug substance, Drug product | 2017-10-16 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N208716-001 | 7855211 | 2031-09-28 | U-3265 | Drug substance, Drug product | 2017-10-16 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N208716-001 | 7855211 | 2031-09-28 | U-3242 | Drug substance, Drug product | 2017-10-16 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N208716-002 | 7855211 | 2031-09-28 | U-2135 | Drug substance, Drug product | 2017-10-16 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N208716-002 | 7855211 | 2031-09-28 | U-3546 | Drug substance, Drug product | 2017-10-16 | caaa826d4ba7… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208716-001 | I-877 | 2024-10-12 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208716-001 | NPP | 2024-10-12 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208716-002 | I-877 | 2024-10-12 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208716-002 | NPP | 2024-10-12 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208716-003 | I-877 | 2024-10-12 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208716-003 | NPP | 2024-10-12 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208716-004 | I-877 | 2024-10-12 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208716-004 | NPP | 2024-10-12 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208716-001 | I-877 | 2024-10-12 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208716-001 | NPP | 2024-10-12 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208716-002 | I-877 | 2024-10-12 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208716-002 | NPP | 2024-10-12 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208716-003 | I-877 | 2024-10-12 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208716-003 | NPP | 2024-10-12 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208716-004 | I-877 | 2024-10-12 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208716-004 | NPP | 2024-10-12 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208716-001 | I-877 | 2024-10-12 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208716-001 | NPP | 2024-10-12 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208716-002 | I-877 | 2024-10-12 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208716-002 | NPP | 2024-10-12 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208716-003 | I-877 | 2024-10-12 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208716-003 | NPP | 2024-10-12 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208716-004 | I-877 | 2024-10-12 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208716-004 | NPP | 2024-10-12 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N208716-001 | I-877 | 2024-10-12 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N208716-001 | NPP | 2024-10-12 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N208716-002 | I-877 | 2024-10-12 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N208716-002 | NPP | 2024-10-12 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N208716-003 | I-877 | 2024-10-12 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N208716-003 | NPP | 2024-10-12 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N208716-004 | I-877 | 2024-10-12 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N208716-004 | NPP | 2024-10-12 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N208716-001 | I-877 | 2024-10-12 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N208716-001 | NPP | 2024-10-12 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N208716-002 | I-877 | 2024-10-12 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N208716-002 | NPP | 2024-10-12 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N208716-003 | I-877 | 2024-10-12 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N208716-003 | NPP | 2024-10-12 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N208716-004 | I-877 | 2024-10-12 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N208716-004 | NPP | 2024-10-12 | d06236e962d9… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0002-4483 | Verzenio | abemaciclib | Eli Lilly and Company | NDA | Current |
| 0002-4483 | Verzenio | abemaciclib | Eli Lilly and Company | NDA | Current |
| 0002-4483 | Verzenio | abemaciclib | Eli Lilly and Company | NDA | Current |
| 0002-4483 | Verzenio | abemaciclib | Eli Lilly and Company | NDA | Current |
| 0002-4483 | Verzenio | abemaciclib | Eli Lilly and Company | NDA | Current |
| 0002-4483 | Verzenio | abemaciclib | Eli Lilly and Company | NDA | Current |
| 0002-4815 | Verzenio | abemaciclib | Eli Lilly and Company | NDA | Current |
| 0002-4815 | Verzenio | abemaciclib | Eli Lilly and Company | NDA | Current |
| 0002-4815 | Verzenio | abemaciclib | Eli Lilly and Company | NDA | Current |
| 0002-4815 | Verzenio | abemaciclib | Eli Lilly and Company | NDA | Current |
| 0002-4815 | Verzenio | abemaciclib | Eli Lilly and Company | NDA | Current |
| 0002-4815 | Verzenio | abemaciclib | Eli Lilly and Company | NDA | Current |
| 0002-5337 | Verzenio | abemaciclib | Eli Lilly and Company | NDA | Current |
| 0002-5337 | Verzenio | abemaciclib | Eli Lilly and Company | NDA | Current |
| 0002-5337 | Verzenio | abemaciclib | Eli Lilly and Company | NDA | Current |
| 0002-5337 | Verzenio | abemaciclib | Eli Lilly and Company | NDA | Current |
| 0002-5337 | Verzenio | abemaciclib | Eli Lilly and Company | NDA | Current |
| 0002-5337 | Verzenio | abemaciclib | Eli Lilly and Company | NDA | Current |
| 0002-6216 | Verzenio | abemaciclib | Eli Lilly and Company | NDA | Current |
| 0002-6216 | Verzenio | abemaciclib | Eli Lilly and Company | NDA | Current |
| 0002-6216 | Verzenio | abemaciclib | Eli Lilly and Company | NDA | Current |
| 0002-6216 | Verzenio | abemaciclib | Eli Lilly and Company | NDA | Current |
| 0002-6216 | Verzenio | abemaciclib | Eli Lilly and Company | NDA | Current |
| 0002-6216 | Verzenio | abemaciclib | Eli Lilly and Company | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 81385 | SUPPL | 2025-03-03 |
| 81381 | SUPPL | 2025-02-28 |
| 80215 | SUPPL | 2024-11-14 |
| 80213 | SUPPL | 2024-11-14 |
| 73682 | SUPPL | 2023-03-06 |
| 73681 | SUPPL | 2023-03-06 |
| 73674 | SUPPL | 2023-03-03 |
| 73673 | SUPPL | 2023-03-03 |
| 68982 | SUPPL | 2021-10-14 |
| 68981 | SUPPL | 2021-10-14 |
| 68980 | SUPPL | 2021-10-14 |
| 68967 | SUPPL | 2021-10-13 |
| 68966 | SUPPL | 2021-10-13 |
| 68965 | SUPPL | 2021-10-13 |
| 62406 | SUPPL | 2020-04-01 |
| 62394 | SUPPL | 2020-03-31 |
| 59972 | SUPPL | 2019-09-11 |
| 59957 | SUPPL | 2019-09-09 |
| 55257 | SUPPL | 2018-08-21 |
| 55214 | SUPPL | 2018-08-20 |
| 50236 | ORIG | 2017-10-31 |
| 49891 | ORIG | 2017-09-28 |
| 49872 | ORIG | 2017-09-28 |