Application 206910

Type: NDA
Sponsor: NOVARTIS PHARMS CORP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	JADENU	DEFERASIROX	TABLET;ORAL	90MG	Yes	No
002	JADENU	DEFERASIROX	TABLET;ORAL	180MG	Yes	No
003	JADENU	DEFERASIROX	TABLET;ORAL	360MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N206910-001	JADENU	DEFERASIROX	90MG	TABLET / ORAL	AB	RLD	2015-03-30
N206910-002	JADENU	DEFERASIROX	180MG	TABLET / ORAL	AB	RLD	2015-03-30
N206910-003	JADENU	DEFERASIROX	360MG	TABLET / ORAL	AB	RLD, RS	2015-03-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N206910-001	AB
N206910-002	AB
N206910-003	AB

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N206910-001	9283209	2034-11-21	Drug substance, Drug product	2016-04-11
N206910-002	9283209	2034-11-21	Drug substance, Drug product	2016-04-11
N206910-003	9283209	2034-11-21	Drug substance, Drug product	2016-04-11

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 4 · 123 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
2026-02-19 14:30 UTC	2026-02	N206910-001	JADENU	90MG	TABLET / ORAL	AB	RLD	2015-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206910-002	JADENU	180MG	TABLET / ORAL	AB	RLD	2015-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206910-003	JADENU	360MG	TABLET / ORAL	AB	RLD, RS	2015-03-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206910-001	JADENU	90MG	TABLET / ORAL	AB	RLD	2015-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206910-002	JADENU	180MG	TABLET / ORAL	AB	RLD	2015-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206910-003	JADENU	360MG	TABLET / ORAL	AB	RLD, RS	2015-03-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206910-001	JADENU	90MG	TABLET / ORAL	AB	RLD	2015-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206910-002	JADENU	180MG	TABLET / ORAL	AB	RLD	2015-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206910-003	JADENU	360MG	TABLET / ORAL	AB	RLD, RS	2015-03-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206910-001	JADENU	90MG	TABLET / ORAL	AB	RLD	2015-03-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206910-002	JADENU	180MG	TABLET / ORAL	AB	RLD	2015-03-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206910-003	JADENU	360MG	TABLET / ORAL	AB	RLD, RS	2015-03-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206910-001	JADENU	90MG	TABLET / ORAL	AB	RLD	2015-03-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206910-002	JADENU	180MG	TABLET / ORAL	AB	RLD	2015-03-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206910-003	JADENU	360MG	TABLET / ORAL	AB	RLD, RS	2015-03-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206910-001	JADENU	90MG	TABLET / ORAL	AB	RLD	2015-03-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206910-002	JADENU	180MG	TABLET / ORAL	AB	RLD	2015-03-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206910-003	JADENU	360MG	TABLET / ORAL	AB	RLD, RS	2015-03-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206910-001	JADENU	90MG	TABLET / ORAL	AB	RLD	2015-03-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206910-002	JADENU	180MG	TABLET / ORAL	AB	RLD	2015-03-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206910-003	JADENU	360MG	TABLET / ORAL	AB	RLD, RS	2015-03-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206910-001	JADENU	90MG	TABLET / ORAL	AB	RLD	2015-03-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206910-002	JADENU	180MG	TABLET / ORAL	AB	RLD	2015-03-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206910-003	JADENU	360MG	TABLET / ORAL	AB	RLD, RS	2015-03-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206910-001	JADENU	90MG	TABLET / ORAL	AB	RLD	2015-03-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206910-002	JADENU	180MG	TABLET / ORAL	AB	RLD	2015-03-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206910-003	JADENU	360MG	TABLET / ORAL	AB	RLD, RS	2015-03-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N206910-001	JADENU	90MG	TABLET / ORAL	AB	RLD	2015-03-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N206910-002	JADENU	180MG	TABLET / ORAL	AB	RLD	2015-03-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N206910-003	JADENU	360MG	TABLET / ORAL	AB	RLD, RS	2015-03-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206910-001	JADENU	90MG	TABLET / ORAL	AB	RLD	2015-03-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206910-002	JADENU	180MG	TABLET / ORAL	AB	RLD	2015-03-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206910-003	JADENU	360MG	TABLET / ORAL	AB	RLD, RS	2015-03-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206910-001	JADENU	90MG	TABLET / ORAL	AB	RLD	2015-03-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206910-002	JADENU	180MG	TABLET / ORAL	AB	RLD	2015-03-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206910-003	JADENU	360MG	TABLET / ORAL	AB	RLD, RS	2015-03-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206910-001	JADENU	90MG	TABLET / ORAL	AB	RLD	2015-03-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206910-002	JADENU	180MG	TABLET / ORAL	AB	RLD	2015-03-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206910-003	JADENU	360MG	TABLET / ORAL	AB	RLD, RS	2015-03-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N206910-001	JADENU	90MG	TABLET / ORAL	AB	RLD	2015-03-30	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 113 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N206910-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206910-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206910-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206910-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206910-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206910-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206910-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206910-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206910-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206910-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206910-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206910-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206910-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206910-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206910-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206910-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206910-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206910-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206910-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206910-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206910-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206910-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206910-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206910-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206910-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206910-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206910-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N206910-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N206910-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N206910-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206910-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206910-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206910-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206910-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206910-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206910-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206910-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206910-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206910-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N206910-001	AB	1	`8072bd15b7f6…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 135 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N206910-001	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206910-002	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206910-003	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206910-001	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206910-002	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206910-003	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206910-001	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206910-002	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206910-003	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206910-001	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206910-002	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206910-003	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206910-001	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206910-002	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206910-003	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206910-001	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206910-002	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206910-003	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206910-001	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206910-002	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206910-003	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206910-001	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206910-002	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206910-003	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206910-001	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206910-002	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206910-003	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N206910-001	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N206910-002	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N206910-003	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206910-001	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206910-002	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206910-003	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206910-001	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206910-002	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206910-003	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206910-001	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206910-002	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206910-003	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N206910-001	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`8072bd15b7f6…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 4 · 156 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	N206910-001	M-241	2022-07-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206910-001	M-263	2023-07-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206910-002	M-241	2022-07-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206910-002	M-263	2023-07-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206910-003	M-241	2022-07-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206910-003	M-263	2023-07-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N206910-001	M-241	2022-07-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N206910-001	M-263	2023-07-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N206910-002	M-241	2022-07-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N206910-002	M-263	2023-07-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N206910-003	M-241	2022-07-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N206910-003	M-263	2023-07-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N206910-001	M-241	2022-07-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N206910-001	M-263	2023-07-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N206910-002	M-241	2022-07-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N206910-002	M-263	2023-07-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N206910-003	M-241	2022-07-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N206910-003	M-263	2023-07-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N206910-001	ODE-39	2020-01-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N206910-001	M-239	2021-12-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N206910-001	M-241	2022-07-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N206910-002	ODE-39	2020-01-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N206910-002	M-239	2021-12-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N206910-002	M-241	2022-07-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N206910-003	ODE-39	2020-01-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N206910-003	M-239	2021-12-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N206910-003	M-241	2022-07-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N206910-001	M-241	2022-07-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N206910-001	M-263	2023-07-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N206910-002	M-241	2022-07-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N206910-002	M-263	2023-07-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N206910-003	M-241	2022-07-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N206910-003	M-263	2023-07-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N206910-001	M-239	2021-12-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N206910-001	M-241	2022-07-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N206910-001	M-263	2023-07-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N206910-002	M-239	2021-12-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N206910-002	M-241	2022-07-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N206910-002	M-263	2023-07-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N206910-003	M-239	2021-12-12	`782e0a99824c…`

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
Jadenu	DEFERASIROX	Novartis Pharmaceuticals Corporation	fee89140-fff1-4443-9f42-24ac004fcda1	2025-12-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 206910 application number: NDA206910 ndc (product): 0078-0654 ndc (product): 0078-0656 ndc (product): 0078-0655

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0078-0654	Jadenu	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0654	Jadenu	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0654	Jadenu	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0654	Jadenu	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0654	Jadenu	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0654	Jadenu	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0654	Jadenu	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0654	Jadenu	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0655	Jadenu	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0655	Jadenu	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0655	Jadenu	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0655	Jadenu	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0655	Jadenu	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0655	Jadenu	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0655	Jadenu	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0655	Jadenu	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0656	Jadenu	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0656	Jadenu	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0656	Jadenu	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0656	Jadenu	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0656	Jadenu	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0656	Jadenu	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0656	Jadenu	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0656	Jadenu	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80209	SUPPL	2024-11-14
80208	SUPPL	2024-11-14
64104	SUPPL	2020-07-27
64103	SUPPL	2020-07-27
64088	SUPPL	2020-07-27
59477	SUPPL	2019-07-29
59476	SUPPL	2019-07-29
59468	SUPPL	2019-07-26
58941	SUPPL	2019-06-04
58876	SUPPL	2019-05-29
56886	SUPPL	2018-12-20
56885	SUPPL	2018-12-20
56737	SUPPL	2018-12-14
56736	SUPPL	2018-12-14
55128	SUPPL	2018-08-07
55116	SUPPL	2018-08-06
54204	SUPPL	2018-05-16
54175	SUPPL	2018-05-14
52703	SUPPL	2018-02-23
52681	SUPPL	2018-02-22
52129	SUPPL	2018-01-30
52117	SUPPL	2018-01-30
45081	SUPPL	2016-08-17
45122	SUPPL	2016-08-12
46076	ORIG	2016-08-04
40572	SUPPL	2015-10-26
40571	SUPPL	2015-10-26
32833	SUPPL	2015-10-26
32832	SUPPL	2015-10-26
40570	ORIG	2015-04-07
10603	ORIG	2015-04-03