Home Applications 205353 Application 205353
Type NDA
Sponsor SECURA Application Products# Product, Drug, Ingredient table 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
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table 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# Current patent rows page 1 of 1 · 6 matching rows.
Application-product, Patent, Expiration table 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.
Product history page 3 of 4 · 132 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2020-11-12 02:37 UTC 2020-11 N205353-003 FARYDAK EQ 20MG BASE CAPSULE / ORAL RLD, RS 2015-02-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N205353-001 FARYDAK EQ 10MG BASE CAPSULE / ORAL RLD 2015-02-23 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N205353-002 FARYDAK EQ 15MG BASE CAPSULE / ORAL RLD 2015-02-23 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N205353-003 FARYDAK EQ 20MG BASE CAPSULE / ORAL RLD, RS 2015-02-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N205353-001 FARYDAK EQ 10MG BASE CAPSULE / ORAL RLD 2015-02-23 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N205353-002 FARYDAK EQ 15MG BASE CAPSULE / ORAL RLD 2015-02-23 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N205353-003 FARYDAK EQ 20MG BASE CAPSULE / ORAL RLD, RS 2015-02-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N205353-001 FARYDAK EQ 10MG BASE CAPSULE / ORAL RLD 2015-02-23 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N205353-002 FARYDAK EQ 15MG BASE CAPSULE / ORAL RLD 2015-02-23 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N205353-003 FARYDAK EQ 20MG BASE CAPSULE / ORAL RLD, RS 2015-02-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N205353-001 FARYDAK EQ 10MG BASE CAPSULE / ORAL RLD 2015-02-23 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N205353-002 FARYDAK EQ 15MG BASE CAPSULE / ORAL RLD 2015-02-23 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N205353-003 FARYDAK EQ 20MG BASE CAPSULE / ORAL RLD 2015-02-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N205353-001 FARYDAK EQ 10MG BASE CAPSULE / ORAL RLD 2015-02-23 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N205353-002 FARYDAK EQ 15MG BASE CAPSULE / ORAL RLD 2015-02-23 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N205353-003 FARYDAK EQ 20MG BASE CAPSULE / ORAL RLD 2015-02-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N205353-001 FARYDAK EQ 10MG BASE CAPSULE / ORAL RLD 2015-02-23 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N205353-002 FARYDAK EQ 15MG BASE CAPSULE / ORAL RLD 2015-02-23 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N205353-003 FARYDAK EQ 20MG BASE CAPSULE / ORAL RLD 2015-02-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N205353-001 FARYDAK EQ 10MG BASE CAPSULE / ORAL RLD 2015-02-23 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N205353-002 FARYDAK EQ 15MG BASE CAPSULE / ORAL RLD 2015-02-23 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N205353-003 FARYDAK EQ 20MG BASE CAPSULE / ORAL RLD 2015-02-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N205353-001 FARYDAK EQ 10MG BASE CAPSULE / ORAL RLD 2015-02-23 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N205353-002 FARYDAK EQ 15MG BASE CAPSULE / ORAL RLD 2015-02-23 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N205353-003 FARYDAK EQ 20MG BASE CAPSULE / ORAL RLD 2015-02-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N205353-001 FARYDAK EQ 10MG BASE CAPSULE / ORAL RLD 2015-02-23 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N205353-002 FARYDAK EQ 15MG BASE CAPSULE / ORAL RLD 2015-02-23 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N205353-003 FARYDAK EQ 20MG BASE CAPSULE / ORAL RLD 2015-02-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N205353-001 FARYDAK EQ 10MG BASE CAPSULE / ORAL RLD 2015-02-23 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N205353-002 FARYDAK EQ 15MG BASE CAPSULE / ORAL RLD 2015-02-23 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N205353-003 FARYDAK EQ 20MG BASE CAPSULE / ORAL RLD 2015-02-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N205353-001 FARYDAK EQ 10MG BASE CAPSULE / ORAL RLD 2015-02-23 053a50430f4f…2023-05-13 08:27 UTC 2023-05 N205353-002 FARYDAK EQ 15MG BASE CAPSULE / ORAL RLD 2015-02-23 053a50430f4f…2023-05-13 08:27 UTC 2023-05 N205353-003 FARYDAK EQ 20MG BASE CAPSULE / ORAL RLD 2015-02-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N205353-001 FARYDAK EQ 10MG BASE CAPSULE / ORAL RLD 2015-02-23 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 N205353-002 FARYDAK EQ 15MG BASE CAPSULE / ORAL RLD 2015-02-23 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 N205353-003 FARYDAK EQ 20MG BASE CAPSULE / ORAL RLD 2015-02-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N205353-001 FARYDAK EQ 10MG BASE CAPSULE / ORAL RLD 2015-02-23 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N205353-002 FARYDAK EQ 15MG BASE CAPSULE / ORAL RLD 2015-02-23 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N205353-003 FARYDAK EQ 20MG BASE CAPSULE / ORAL RLD 2015-02-23 3a93d1ddd44b…
Observed Orange Book patent history# Patent history page 1 of 9 · 345 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N205353-001 7989494 2028-01-17 Drug substance, Drug product 2015-03-20 c2088c7a36db…2026-10-15 13:18:30 2026-09 N205353-001 8883842 2028-06-13 U-1669 2015-03-20 c2088c7a36db…2026-10-15 13:18:30 2026-09 N205353-002 7989494 2028-01-17 Drug substance, Drug product 2015-03-20 c2088c7a36db…2026-10-15 13:18:30 2026-09 N205353-002 8883842 2028-06-13 U-1669 2015-03-20 c2088c7a36db…2026-10-15 13:18:30 2026-09 N205353-003 7989494 2028-01-17 Drug substance, Drug product 2015-03-20 c2088c7a36db…2026-10-15 13:18:30 2026-09 N205353-003 8883842 2028-06-13 U-1669 2015-03-20 c2088c7a36db…2026-09-14 22:38:34 2026-08 N205353-001 7989494 2028-01-17 Drug substance, Drug product 2015-03-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205353-001 8883842 2028-06-13 U-1669 2015-03-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205353-002 7989494 2028-01-17 Drug substance, Drug product 2015-03-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205353-002 8883842 2028-06-13 U-1669 2015-03-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205353-003 7989494 2028-01-17 Drug substance, Drug product 2015-03-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205353-003 8883842 2028-06-13 U-1669 2015-03-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 N205353-001 7989494 2028-01-17 Drug substance, Drug product 2015-03-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205353-001 8883842 2028-06-13 U-1669 2015-03-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205353-002 7989494 2028-01-17 Drug substance, Drug product 2015-03-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205353-002 8883842 2028-06-13 U-1669 2015-03-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205353-003 7989494 2028-01-17 Drug substance, Drug product 2015-03-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205353-003 8883842 2028-06-13 U-1669 2015-03-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N205353-001 7989494 2028-01-17 Drug substance, Drug product 2015-03-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205353-001 8883842 2028-06-13 U-1669 2015-03-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205353-002 7989494 2028-01-17 Drug substance, Drug product 2015-03-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205353-002 8883842 2028-06-13 U-1669 2015-03-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205353-003 7989494 2028-01-17 Drug substance, Drug product 2015-03-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205353-003 8883842 2028-06-13 U-1669 2015-03-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205353-001 7989494 2028-01-17 Drug substance, Drug product 2015-03-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205353-001 8883842 2028-06-13 U-1669 2015-03-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205353-002 7989494 2028-01-17 Drug substance, Drug product 2015-03-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205353-002 8883842 2028-06-13 U-1669 2015-03-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205353-003 7989494 2028-01-17 Drug substance, Drug product 2015-03-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205353-003 8883842 2028-06-13 U-1669 2015-03-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205353-001 7989494 2028-01-17 Drug substance, Drug product 2015-03-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205353-001 8883842 2028-06-13 U-1669 2015-03-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205353-002 7989494 2028-01-17 Drug substance, Drug product 2015-03-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205353-002 8883842 2028-06-13 U-1669 2015-03-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205353-003 7989494 2028-01-17 Drug substance, Drug product 2015-03-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205353-003 8883842 2028-06-13 U-1669 2015-03-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205353-001 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 N205353-001 8883842 2028-06-13 U-1669 2015-03-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205353-002 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 N205353-002 8883842 2028-06-13 U-1669 2015-03-20 fd3edfee7708…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 72 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 23 matching rows.
NDC, Name, Nonproprietary name table 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
Documents# Document, Submission type, Date table Document Submission type Date 32661 SUPPL 2016-06-08 24491 ORIG 2015-03-17 22983 ORIG 2015-03-17 23519 ORIG 2015-03-03 24126 ORIG 2015-02-25 32660 ORIG 2015-02-24 40463 ORIG 2015-02-23