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	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 4 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N205353-001	FARYDAK	EQ 10MG BASE	CAPSULE / ORAL	RLD	2015-02-23	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N205353-002	FARYDAK	EQ 15MG BASE	CAPSULE / ORAL	RLD	2015-02-23	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N205353-003	FARYDAK	EQ 20MG BASE	CAPSULE / ORAL	RLD	2015-02-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N205353-001	FARYDAK	EQ 10MG BASE	CAPSULE / ORAL	RLD	2015-02-23	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N205353-002	FARYDAK	EQ 15MG BASE	CAPSULE / ORAL	RLD	2015-02-23	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N205353-003	FARYDAK	EQ 20MG BASE	CAPSULE / ORAL	RLD	2015-02-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N205353-001	FARYDAK	EQ 10MG BASE	CAPSULE / ORAL	RLD	2015-02-23	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N205353-002	FARYDAK	EQ 15MG BASE	CAPSULE / ORAL	RLD	2015-02-23	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N205353-003	FARYDAK	EQ 20MG BASE	CAPSULE / ORAL	RLD	2015-02-23	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N205353-001	FARYDAK	EQ 10MG BASE	CAPSULE / ORAL	RLD	2015-02-23	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N205353-002	FARYDAK	EQ 15MG BASE	CAPSULE / ORAL	RLD	2015-02-23	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N205353-003	FARYDAK	EQ 20MG BASE	CAPSULE / ORAL	RLD	2015-02-23	`a50c72e98297…`

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.

Captured, Edition, Application-product table
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 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