Application 022527

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GILENYA	FINGOLIMOD HYDROCHLORIDE	CAPSULE;ORAL	EQ 0.5MG BASE	Yes	Yes
002	GILENYA	FINGOLIMOD HYDROCHLORIDE	CAPSULE;ORAL	EQ 0.25MG BASE	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022527-001	GILENYA	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-09-21
N022527-002	GILENYA	FINGOLIMOD HYDROCHLORIDE	EQ 0.25MG BASE	CAPSULE / ORAL		RLD	2018-05-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N022527-001	AB

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022527-001	10543179	2027-12-25	U-2719		2020-01-28
N022527-002	9592208	2032-03-30	U-2315	Drug product	2018-06-19
N022527-002	9592208*PED	2032-09-30		Pediatric extension

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 1 of 3 · 84 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
2026-08-18 06:07:40	2026-07	N022527-001	GILENYA	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-09-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022527-002	GILENYA	EQ 0.25MG BASE	CAPSULE / ORAL		RLD	2018-05-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022527-001	GILENYA	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-09-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022527-002	GILENYA	EQ 0.25MG BASE	CAPSULE / ORAL		RLD	2018-05-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022527-001	GILENYA	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-09-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022527-002	GILENYA	EQ 0.25MG BASE	CAPSULE / ORAL		RLD	2018-05-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022527-001	GILENYA	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-09-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022527-002	GILENYA	EQ 0.25MG BASE	CAPSULE / ORAL		RLD	2018-05-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022527-001	GILENYA	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-09-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022527-002	GILENYA	EQ 0.25MG BASE	CAPSULE / ORAL		RLD	2018-05-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022527-001	GILENYA	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-09-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022527-002	GILENYA	EQ 0.25MG BASE	CAPSULE / ORAL		RLD	2018-05-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022527-001	GILENYA	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-09-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022527-002	GILENYA	EQ 0.25MG BASE	CAPSULE / ORAL		RLD	2018-05-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022527-001	GILENYA	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-09-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022527-002	GILENYA	EQ 0.25MG BASE	CAPSULE / ORAL		RLD	2018-05-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022527-001	GILENYA	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-09-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022527-002	GILENYA	EQ 0.25MG BASE	CAPSULE / ORAL		RLD	2018-05-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022527-001	GILENYA	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-09-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022527-002	GILENYA	EQ 0.25MG BASE	CAPSULE / ORAL		RLD	2018-05-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022527-001	GILENYA	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-09-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022527-002	GILENYA	EQ 0.25MG BASE	CAPSULE / ORAL		RLD	2018-05-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022527-001	GILENYA	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-09-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022527-002	GILENYA	EQ 0.25MG BASE	CAPSULE / ORAL		RLD	2018-05-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022527-001	GILENYA	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-09-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022527-002	GILENYA	EQ 0.25MG BASE	CAPSULE / ORAL		RLD	2018-05-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022527-001	GILENYA	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-09-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022527-002	GILENYA	EQ 0.25MG BASE	CAPSULE / ORAL		RLD	2018-05-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022527-001	GILENYA	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-09-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022527-002	GILENYA	EQ 0.25MG BASE	CAPSULE / ORAL		RLD	2018-05-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022527-001	GILENYA	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-09-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022527-002	GILENYA	EQ 0.25MG BASE	CAPSULE / ORAL	AB	RLD	2018-05-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022527-001	GILENYA	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-09-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022527-002	GILENYA	EQ 0.25MG BASE	CAPSULE / ORAL	AB	RLD	2018-05-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022527-001	GILENYA	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-09-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022527-002	GILENYA	EQ 0.25MG BASE	CAPSULE / ORAL	AB	RLD	2018-05-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022527-001	GILENYA	EQ 0.5MG BASE	CAPSULE / ORAL		RLD, RS	2010-09-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022527-002	GILENYA	EQ 0.25MG BASE	CAPSULE / ORAL		RLD	2018-05-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022527-001	GILENYA	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-09-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022527-002	GILENYA	EQ 0.25MG BASE	CAPSULE / ORAL	AB	RLD	2018-05-11	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N022527-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022527-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022527-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022527-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022527-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022527-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022527-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022527-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022527-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022527-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022527-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022527-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022527-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022527-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022527-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022527-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022527-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022527-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022527-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022527-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022527-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N022527-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022527-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022527-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022527-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022527-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022527-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022527-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022527-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022527-001	AB	1	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022527-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022527-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022527-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022527-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022527-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022527-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022527-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022527-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022527-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022527-001	AB	1	`3a93d1ddd44b…`

Observed Orange Book patent history#

Patent history page 1 of 8 · 287 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N022527-001	10543179	2027-12-25	U-2719		2020-01-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022527-002	9592208	2032-03-30	U-2315	Drug product	2018-06-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022527-002	9592208*PED	2032-09-30		Pediatric extension		`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022527-001	10543179	2027-12-25	U-2719		2020-01-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022527-002	9592208	2032-03-30	U-2315	Drug product	2018-06-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022527-002	9592208*PED	2032-09-30		Pediatric extension		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022527-001	10543179	2027-12-25	U-2719		2020-01-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022527-002	9592208	2032-03-30	U-2315	Drug product	2018-06-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022527-002	9592208*PED	2032-09-30		Pediatric extension		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022527-001	10543179	2027-12-25	U-2719		2020-01-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022527-002	9592208	2032-03-30	U-2315	Drug product	2018-06-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022527-002	9592208*PED	2032-09-30		Pediatric extension		`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022527-001	10543179	2027-12-25	U-2719		2020-01-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022527-002	9592208	2032-03-30	U-2315	Drug product	2018-06-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022527-002	9592208*PED	2032-09-30		Pediatric extension		`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022527-001	8324283	2026-03-29		Drug product	2013-01-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022527-001	8324283*PED	2026-09-29		Pediatric extension		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022527-001	9187405	2027-06-25	U-2613		2015-12-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022527-001	10543179	2027-12-25	U-2719		2020-01-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022527-001	9187405*PED	2027-12-25		Pediatric extension		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022527-002	9592208	2032-03-30	U-2315	Drug product	2018-06-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022527-002	9592208*PED	2032-09-30		Pediatric extension		`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022527-001	8324283	2026-03-29		Drug product	2013-01-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022527-001	8324283*PED	2026-09-29		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022527-001	9187405	2027-06-25	U-2613		2015-12-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022527-001	10543179	2027-12-25	U-2719		2020-01-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022527-001	9187405*PED	2027-12-25		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022527-002	9592208	2032-03-30	U-2315	Drug product	2018-06-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022527-002	9592208*PED	2032-09-30		Pediatric extension		`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022527-001	8324283	2026-03-29		Drug product	2013-01-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022527-001	8324283*PED	2026-09-29		Pediatric extension		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022527-001	9187405	2027-06-25	U-2613		2015-12-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022527-001	10543179	2027-12-25	U-2719		2020-01-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022527-001	9187405*PED	2027-12-25		Pediatric extension		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022527-002	9592208	2032-03-30	U-2315	Drug product	2018-06-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022527-002	9592208*PED	2032-09-30		Pediatric extension		`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022527-001	8324283	2026-03-29		Drug product	2013-01-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022527-001	8324283*PED	2026-09-29		Pediatric extension		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022527-001	9187405	2027-06-25	U-2613		2015-12-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022527-001	10543179	2027-12-25	U-2719		2020-01-28	`5bbf6a4d5a75…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N022527-001	NPP	2021-05-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022527-001	PED	2021-11-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022527-002	NS	2021-05-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022527-002	PED	2021-11-11	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N022527-001	NPP	2021-05-11	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022527-001	PED	2021-11-11	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022527-002	NS	2021-05-11	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022527-002	PED	2021-11-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022527-001	NPP	2021-05-11	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022527-001	PED	2021-11-11	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022527-002	NS	2021-05-11	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022527-002	PED	2021-11-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022527-001	NPP	2021-05-11	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022527-001	PED	2021-11-11	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022527-002	NS	2021-05-11	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022527-002	PED	2021-11-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022527-001	NPP	2021-05-11	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022527-001	PED	2021-11-11	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022527-002	NS	2021-05-11	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022527-002	PED	2021-11-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022527-001	NPP	2021-05-11	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022527-001	PED	2021-11-11	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022527-002	NS	2021-05-11	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022527-002	PED	2021-11-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022527-001	NPP	2021-05-11	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022527-001	PED	2021-11-11	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022527-002	NS	2021-05-11	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022527-002	PED	2021-11-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022527-001	NPP	2021-05-11	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022527-001	PED	2021-11-11	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022527-002	NS	2021-05-11	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022527-002	PED	2021-11-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022527-001	NPP	2021-05-11	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022527-001	PED	2021-11-11	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022527-002	NS	2021-05-11	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022527-002	PED	2021-11-11	`ea99ee380514…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gilenya	FINGOLIMOD HCL	Novartis Pharmaceuticals Corporation	cc9e1c8c-0e2b-44e2-878b-27057f786be9	2026-07-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022527 application number: NDA022527 ndc (product): 0078-0965 ndc (product): 0078-0607

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0078-0607	Gilenya	Fingolimod hcl	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0607	Gilenya	Fingolimod hcl	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0607	Gilenya	Fingolimod hcl	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0607	Gilenya	Fingolimod hcl	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0607	Gilenya	Fingolimod hcl	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0607	Gilenya	Fingolimod hcl	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0607	Gilenya	Fingolimod hcl	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0607	Gilenya	Fingolimod hcl	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0965	Gilenya	Fingolimod hcl	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0965	Gilenya	Fingolimod hcl	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0965	Gilenya	Fingolimod hcl	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0965	Gilenya	Fingolimod hcl	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0965	Gilenya	Fingolimod hcl	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0965	Gilenya	Fingolimod hcl	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0965	Gilenya	Fingolimod hcl	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0965	Gilenya	Fingolimod hcl	Novartis Pharmaceuticals Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83195	SUPPL	2025-08-26
83186	SUPPL	2025-08-25
83185	SUPPL	2025-08-25
78721	SUPPL	2024-06-07
78687	SUPPL	2024-06-06
76869	SUPPL	2023-12-15
75049	SUPPL	2023-12-05
75043	SUPPL	2023-08-11
61501	SUPPL	2020-01-02
61462	SUPPL	2019-12-27
59747	SUPPL	2019-09-20
59746	SUPPL	2019-09-20
59794	SUPPL	2019-08-21
59793	SUPPL	2019-08-21
59792	SUPPL	2019-08-21
59791	SUPPL	2019-08-21
57261	SUPPL	2019-01-18
57194	SUPPL	2019-01-14
56166	SUPPL	2018-10-30
54197	SUPPL	2018-05-15
54171	SUPPL	2018-05-11
50834	SUPPL	2017-12-22
50783	SUPPL	2017-12-20
45973	SUPPL	2016-12-01
17684	SUPPL	2016-02-23
7508	SUPPL	2016-02-23
29835	SUPPL	2015-08-06
17685	SUPPL	2015-08-06
7507	SUPPL	2015-07-10
17683	SUPPL	2015-07-06
7506	SUPPL	2015-05-19
38818	SUPPL	2015-05-04
7505	SUPPL	2015-05-04
17682	SUPPL	2014-05-02
29833	SUPPL	2014-05-01
29834	SUPPL	2013-05-29
7504	SUPPL	2012-05-11
38817	SUPPL	2012-05-10
38816	SUPPL	2012-03-20
29832	SUPPL	2012-03-20
7503	SUPPL	2012-03-05
44188	ORIG	2011-12-21
38814	SUPPL	2011-07-25
7502	SUPPL	2011-07-25
38815	SUPPL	2011-07-06
44771	ORIG	2011-02-17
22046	ORIG	2010-11-12
7501	ORIG	2010-09-27
17681	ORIG	2010-09-23
66911	ORIG	1900-01-01
63006	SUPPL	1900-01-01
63005	SUPPL	1900-01-01
63004	SUPPL	1900-01-01
63003	SUPPL	1900-01-01