Application 205353
- Type
- NDA
- Sponsor
- SECURA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FARYDAK | PANOBINOSTAT LACTATE | CAPSULE;ORAL | EQ 10MG BASE | Yes | No |
| 002 | FARYDAK | PANOBINOSTAT LACTATE | CAPSULE;ORAL | EQ 15MG BASE | Yes | No |
| 003 | FARYDAK | PANOBINOSTAT LACTATE | CAPSULE;ORAL | EQ 20MG BASE | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N205353-001 | FARYDAK | PANOBINOSTAT LACTATE | EQ 10MG BASE | CAPSULE / ORAL | RLD | 2015-02-23 | |
| N205353-002 | FARYDAK | PANOBINOSTAT LACTATE | EQ 15MG BASE | CAPSULE / ORAL | RLD | 2015-02-23 | |
| N205353-003 | FARYDAK | PANOBINOSTAT LACTATE | EQ 20MG BASE | CAPSULE / ORAL | RLD | 2015-02-23 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N205353-001 | 7989494 | 2028-01-17 | Drug substance, Drug product | 2015-03-20 | |
| N205353-001 | 8883842 | 2028-06-13 | U-1669 | 2015-03-20 | |
| N205353-002 | 7989494 | 2028-01-17 | Drug substance, Drug product | 2015-03-20 | |
| N205353-002 | 8883842 | 2028-06-13 | U-1669 | 2015-03-20 | |
| N205353-003 | 7989494 | 2028-01-17 | Drug substance, Drug product | 2015-03-20 | |
| N205353-003 | 8883842 | 2028-06-13 | U-1669 | 2015-03-20 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N205353-001 | FARYDAK | EQ 10MG BASE | CAPSULE / ORAL | RLD | 2015-02-23 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N205353-002 | FARYDAK | EQ 15MG BASE | CAPSULE / ORAL | RLD | 2015-02-23 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N205353-003 | FARYDAK | EQ 20MG BASE | CAPSULE / ORAL | RLD | 2015-02-23 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | N205353-001 | FARYDAK | EQ 10MG BASE | CAPSULE / ORAL | RLD | 2015-02-23 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N205353-002 | FARYDAK | EQ 15MG BASE | CAPSULE / ORAL | RLD | 2015-02-23 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N205353-003 | FARYDAK | EQ 20MG BASE | CAPSULE / ORAL | RLD | 2015-02-23 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N205353-001 | FARYDAK | EQ 10MG BASE | CAPSULE / ORAL | RLD | 2015-02-23 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N205353-002 | FARYDAK | EQ 15MG BASE | CAPSULE / ORAL | RLD | 2015-02-23 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N205353-003 | FARYDAK | EQ 20MG BASE | CAPSULE / ORAL | RLD | 2015-02-23 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N205353-001 | FARYDAK | EQ 10MG BASE | CAPSULE / ORAL | RLD | 2015-02-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N205353-002 | FARYDAK | EQ 15MG BASE | CAPSULE / ORAL | RLD | 2015-02-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N205353-003 | FARYDAK | EQ 20MG BASE | CAPSULE / ORAL | RLD | 2015-02-23 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205353-001 | FARYDAK | EQ 10MG BASE | CAPSULE / ORAL | RLD | 2015-02-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205353-002 | FARYDAK | EQ 15MG BASE | CAPSULE / ORAL | RLD | 2015-02-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205353-003 | FARYDAK | EQ 20MG BASE | CAPSULE / ORAL | RLD | 2015-02-23 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N205353-001 | FARYDAK | EQ 10MG BASE | CAPSULE / ORAL | RLD | 2015-02-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N205353-002 | FARYDAK | EQ 15MG BASE | CAPSULE / ORAL | RLD | 2015-02-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N205353-003 | FARYDAK | EQ 20MG BASE | CAPSULE / ORAL | RLD | 2015-02-23 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205353-001 | FARYDAK | EQ 10MG BASE | CAPSULE / ORAL | RLD | 2015-02-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205353-002 | FARYDAK | EQ 15MG BASE | CAPSULE / ORAL | RLD | 2015-02-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205353-003 | FARYDAK | EQ 20MG BASE | CAPSULE / ORAL | RLD | 2015-02-23 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N205353-001 | FARYDAK | EQ 10MG BASE | CAPSULE / ORAL | RLD | 2015-02-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N205353-002 | FARYDAK | EQ 15MG BASE | CAPSULE / ORAL | RLD | 2015-02-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N205353-003 | FARYDAK | EQ 20MG BASE | CAPSULE / ORAL | RLD | 2015-02-23 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N205353-001 | FARYDAK | EQ 10MG BASE | CAPSULE / ORAL | RLD | 2015-02-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N205353-002 | FARYDAK | EQ 15MG BASE | CAPSULE / ORAL | RLD | 2015-02-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N205353-003 | FARYDAK | EQ 20MG BASE | CAPSULE / ORAL | RLD | 2015-02-23 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N205353-001 | FARYDAK | EQ 10MG BASE | CAPSULE / ORAL | RLD | 2015-02-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N205353-002 | FARYDAK | EQ 15MG BASE | CAPSULE / ORAL | RLD | 2015-02-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N205353-003 | FARYDAK | EQ 20MG BASE | CAPSULE / ORAL | RLD | 2015-02-23 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N205353-001 | FARYDAK | EQ 10MG BASE | CAPSULE / ORAL | RLD | 2015-02-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N205353-002 | FARYDAK | EQ 15MG BASE | CAPSULE / ORAL | RLD | 2015-02-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N205353-003 | FARYDAK | EQ 20MG BASE | CAPSULE / ORAL | RLD | 2015-02-23 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N205353-001 | FARYDAK | EQ 10MG BASE | CAPSULE / ORAL | RLD | 2015-02-23 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N205353-002 | FARYDAK | EQ 15MG BASE | CAPSULE / ORAL | RLD | 2015-02-23 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N205353-003 | FARYDAK | EQ 20MG BASE | CAPSULE / ORAL | RLD | 2015-02-23 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N205353-001 | FARYDAK | EQ 10MG BASE | CAPSULE / ORAL | RLD | 2015-02-23 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N205353-002 | FARYDAK | EQ 15MG BASE | CAPSULE / ORAL | RLD | 2015-02-23 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N205353-003 | FARYDAK | EQ 20MG BASE | CAPSULE / ORAL | RLD | 2015-02-23 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N205353-001 | FARYDAK | EQ 10MG BASE | CAPSULE / ORAL | RLD | 2015-02-23 | 79d66fd596c7… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205353-003 | 7989494 | 2028-01-17 | Drug substance, Drug product | 2015-03-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205353-003 | 8883842 | 2028-06-13 | U-1669 | 2015-03-20 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N205353-001 | 7989494 | 2028-01-17 | Drug substance, Drug product | 2015-03-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N205353-001 | 8883842 | 2028-06-13 | U-1669 | 2015-03-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N205353-002 | 7989494 | 2028-01-17 | Drug substance, Drug product | 2015-03-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N205353-002 | 8883842 | 2028-06-13 | U-1669 | 2015-03-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N205353-003 | 7989494 | 2028-01-17 | Drug substance, Drug product | 2015-03-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N205353-003 | 8883842 | 2028-06-13 | U-1669 | 2015-03-20 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N205353-001 | 7989494 | 2028-01-17 | Drug substance, Drug product | 2015-03-20 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N205353-001 | 8883842 | 2028-06-13 | U-1669 | 2015-03-20 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N205353-002 | 7989494 | 2028-01-17 | Drug substance, Drug product | 2015-03-20 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N205353-002 | 8883842 | 2028-06-13 | U-1669 | 2015-03-20 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N205353-003 | 7989494 | 2028-01-17 | Drug substance, Drug product | 2015-03-20 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N205353-003 | 8883842 | 2028-06-13 | U-1669 | 2015-03-20 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N205353-001 | 7989494 | 2028-01-17 | Drug substance, Drug product | 2015-03-20 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N205353-001 | 8883842 | 2028-06-13 | U-1669 | 2015-03-20 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N205353-002 | 7989494 | 2028-01-17 | Drug substance, Drug product | 2015-03-20 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N205353-002 | 8883842 | 2028-06-13 | U-1669 | 2015-03-20 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N205353-003 | 7989494 | 2028-01-17 | Drug substance, Drug product | 2015-03-20 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N205353-003 | 8883842 | 2028-06-13 | U-1669 | 2015-03-20 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N205353-001 | 7989494 | 2028-01-17 | Drug substance, Drug product | 2015-03-20 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N205353-001 | 8883842 | 2028-06-13 | U-1669 | 2015-03-20 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N205353-002 | 7989494 | 2028-01-17 | Drug substance, Drug product | 2015-03-20 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N205353-002 | 8883842 | 2028-06-13 | U-1669 | 2015-03-20 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N205353-003 | 7989494 | 2028-01-17 | Drug substance, Drug product | 2015-03-20 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N205353-003 | 8883842 | 2028-06-13 | U-1669 | 2015-03-20 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N205353-001 | 7989494 | 2028-01-17 | Drug substance, Drug product | 2015-03-20 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N205353-001 | 8883842 | 2028-06-13 | U-1669 | 2015-03-20 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N205353-002 | 7989494 | 2028-01-17 | Drug substance, Drug product | 2015-03-20 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N205353-002 | 8883842 | 2028-06-13 | U-1669 | 2015-03-20 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N205353-003 | 7989494 | 2028-01-17 | Drug substance, Drug product | 2015-03-20 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N205353-003 | 8883842 | 2028-06-13 | U-1669 | 2015-03-20 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N205353-001 | 7989494 | 2028-01-17 | Drug substance, Drug product | 2015-03-20 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N205353-001 | 8883842 | 2028-06-13 | U-1669 | 2015-03-20 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N205353-002 | 7989494 | 2028-01-17 | Drug substance, Drug product | 2015-03-20 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N205353-002 | 8883842 | 2028-06-13 | U-1669 | 2015-03-20 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N205353-003 | 7989494 | 2028-01-17 | Drug substance, Drug product | 2015-03-20 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N205353-003 | 8883842 | 2028-06-13 | U-1669 | 2015-03-20 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N205353-001 | 7989494 | 2028-01-17 | Drug substance, Drug product | 2015-03-20 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N205353-001 | 8883842 | 2028-06-13 | U-1669 | 2015-03-20 | 79d66fd596c7… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N205353-001 | ODE-89 | 2022-02-23 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N205353-002 | ODE-89 | 2022-02-23 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N205353-003 | ODE-89 | 2022-02-23 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N205353-001 | ODE-89 | 2022-02-23 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N205353-002 | ODE-89 | 2022-02-23 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N205353-003 | ODE-89 | 2022-02-23 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N205353-001 | ODE-89 | 2022-02-23 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N205353-002 | ODE-89 | 2022-02-23 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N205353-003 | ODE-89 | 2022-02-23 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N205353-001 | NCE | 2020-02-23 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N205353-001 | ODE-89 | 2022-02-23 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N205353-002 | NCE | 2020-02-23 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N205353-002 | ODE-89 | 2022-02-23 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N205353-003 | NCE | 2020-02-23 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N205353-003 | ODE-89 | 2022-02-23 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N205353-001 | ODE-89 | 2022-02-23 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N205353-002 | ODE-89 | 2022-02-23 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N205353-003 | ODE-89 | 2022-02-23 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N205353-001 | ODE-89 | 2022-02-23 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N205353-002 | ODE-89 | 2022-02-23 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N205353-003 | ODE-89 | 2022-02-23 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N205353-001 | ODE-89 | 2022-02-23 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N205353-002 | ODE-89 | 2022-02-23 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N205353-003 | ODE-89 | 2022-02-23 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N205353-001 | ODE-89 | 2022-02-23 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N205353-002 | ODE-89 | 2022-02-23 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N205353-003 | ODE-89 | 2022-02-23 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N205353-001 | NCE | 2020-02-23 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N205353-001 | ODE-89 | 2022-02-23 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N205353-002 | NCE | 2020-02-23 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N205353-002 | ODE-89 | 2022-02-23 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N205353-003 | NCE | 2020-02-23 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N205353-003 | ODE-89 | 2022-02-23 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N205353-001 | NCE | 2020-02-23 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N205353-001 | ODE-89 | 2022-02-23 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N205353-002 | NCE | 2020-02-23 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N205353-002 | ODE-89 | 2022-02-23 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N205353-003 | NCE | 2020-02-23 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N205353-003 | ODE-89 | 2022-02-23 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N205353-001 | NCE | 2020-02-23 | 3f01610625f2… |
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 |
|---|---|---|---|---|---|
| 0078-0650 | FARYDAK | panobinostat | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0650 | FARYDAK | panobinostat | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0650 | FARYDAK | panobinostat | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0650 | FARYDAK | panobinostat | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0650 | FARYDAK | panobinostat | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0651 | FARYDAK | panobinostat | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0651 | FARYDAK | panobinostat | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0651 | FARYDAK | panobinostat | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0651 | FARYDAK | panobinostat | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0652 | FARYDAK | panobinostat | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0652 | FARYDAK | panobinostat | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0652 | FARYDAK | panobinostat | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0652 | FARYDAK | panobinostat | Novartis Pharmaceuticals Corporation | NDA | Current |
| 0078-0652 | FARYDAK | panobinostat | Novartis Pharmaceuticals Corporation | NDA | Current |
| 73116-100 | FARYDAK | panobinostat | Secura Bio, Inc. | NDA | Current |
| 73116-100 | FARYDAK | panobinostat | Secura Bio, Inc. | NDA | Current |
| 73116-100 | FARYDAK | panobinostat | Secura Bio, Inc. | NDA | Current |
| 73116-101 | FARYDAK | panobinostat | Secura Bio, Inc. | NDA | Current |
| 73116-101 | FARYDAK | panobinostat | Secura Bio, Inc. | NDA | Current |
| 73116-101 | FARYDAK | panobinostat | Secura Bio, Inc. | NDA | Current |
| 73116-102 | FARYDAK | panobinostat | Secura Bio, Inc. | NDA | Current |
| 73116-102 | FARYDAK | panobinostat | Secura Bio, Inc. | NDA | Current |
| 73116-102 | FARYDAK | panobinostat | Secura Bio, Inc. | NDA | Current |