Application 021882

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EXJADE	DEFERASIROX	TABLET, FOR SUSPENSION;ORAL	125MG	Yes	No
002	EXJADE	DEFERASIROX	TABLET, FOR SUSPENSION;ORAL	250MG	Yes	No
003	EXJADE	DEFERASIROX	TABLET, FOR SUSPENSION;ORAL	500MG	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
N021882-001	EXJADE	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2005-11-02
N021882-002	EXJADE	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2005-11-02
N021882-003	EXJADE	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2005-11-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021882-001	AB
N021882-002	AB
N021882-003	AB

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	N021882-001	EXJADE	125MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2005-11-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021882-002	EXJADE	250MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2005-11-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021882-003	EXJADE	500MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2005-11-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021882-001	EXJADE	125MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2005-11-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021882-002	EXJADE	250MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2005-11-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021882-003	EXJADE	500MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2005-11-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021882-001	EXJADE	125MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2005-11-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021882-002	EXJADE	250MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2005-11-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021882-003	EXJADE	500MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2005-11-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021882-001	EXJADE	125MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2005-11-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021882-002	EXJADE	250MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2005-11-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021882-003	EXJADE	500MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2005-11-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021882-001	EXJADE	125MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2005-11-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021882-002	EXJADE	250MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2005-11-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021882-003	EXJADE	500MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2005-11-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021882-001	EXJADE	125MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2005-11-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021882-002	EXJADE	250MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2005-11-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021882-003	EXJADE	500MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2005-11-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021882-001	EXJADE	125MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2005-11-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021882-002	EXJADE	250MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2005-11-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021882-003	EXJADE	500MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2005-11-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021882-001	EXJADE	125MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2005-11-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021882-002	EXJADE	250MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2005-11-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021882-003	EXJADE	500MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2005-11-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021882-001	EXJADE	125MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2005-11-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021882-002	EXJADE	250MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2005-11-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021882-003	EXJADE	500MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2005-11-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021882-001	EXJADE	125MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2005-11-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021882-002	EXJADE	250MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2005-11-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021882-003	EXJADE	500MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2005-11-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021882-001	EXJADE	125MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2005-11-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021882-002	EXJADE	250MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2005-11-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021882-003	EXJADE	500MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2005-11-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021882-001	EXJADE	125MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2005-11-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021882-002	EXJADE	250MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2005-11-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021882-003	EXJADE	500MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2005-11-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021882-001	EXJADE	125MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2005-11-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021882-002	EXJADE	250MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2005-11-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021882-003	EXJADE	500MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2005-11-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021882-001	EXJADE	125MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2005-11-02	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	N021882-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021882-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021882-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021882-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021882-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021882-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021882-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021882-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021882-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021882-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021882-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021882-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021882-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021882-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021882-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021882-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021882-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021882-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021882-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021882-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021882-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021882-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021882-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021882-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021882-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021882-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021882-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021882-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021882-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021882-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021882-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021882-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021882-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021882-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021882-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021882-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021882-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021882-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021882-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021882-001	AB	1	`8072bd15b7f6…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021882-001	6465504	2019-04-05	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021882-002	6465504	2019-04-05	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021882-003	6465504	2019-04-05	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N021882-001	6465504	2019-04-05	Drug substance, Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021882-002	6465504	2019-04-05	Drug substance, Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021882-003	6465504	2019-04-05	Drug substance, Drug product	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021882-001	6465504	2019-04-05	Drug substance, Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021882-002	6465504	2019-04-05	Drug substance, Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021882-003	6465504	2019-04-05	Drug substance, Drug product	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021882-001	6465504	2019-04-05	Drug substance, Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021882-002	6465504	2019-04-05	Drug substance, Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021882-003	6465504	2019-04-05	Drug substance, Drug product	`ea99ee380514…`

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	N021882-001	M-241	2022-07-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021882-001	M-263	2023-07-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021882-002	M-241	2022-07-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021882-002	M-263	2023-07-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021882-003	M-241	2022-07-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021882-003	M-263	2023-07-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021882-001	M-241	2022-07-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021882-001	M-263	2023-07-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021882-002	M-241	2022-07-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021882-002	M-263	2023-07-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021882-003	M-241	2022-07-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021882-003	M-263	2023-07-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021882-001	M-241	2022-07-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021882-001	M-263	2023-07-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021882-002	M-241	2022-07-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021882-002	M-263	2023-07-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021882-003	M-241	2022-07-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021882-003	M-263	2023-07-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021882-001	ODE-39	2020-01-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021882-001	M-239	2021-12-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021882-001	M-241	2022-07-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021882-002	ODE-39	2020-01-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021882-002	M-239	2021-12-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021882-002	M-241	2022-07-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021882-003	ODE-39	2020-01-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021882-003	M-239	2021-12-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021882-003	M-241	2022-07-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021882-001	M-241	2022-07-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021882-001	M-263	2023-07-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021882-002	M-241	2022-07-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021882-002	M-263	2023-07-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021882-003	M-241	2022-07-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021882-003	M-263	2023-07-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021882-001	M-239	2021-12-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021882-001	M-241	2022-07-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021882-001	M-263	2023-07-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021882-002	M-239	2021-12-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021882-002	M-241	2022-07-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021882-002	M-263	2023-07-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021882-003	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
Exjade	DEFERASIROX	Novartis Pharmaceuticals Corporation	3495a70c-870c-4968-940e-8baea152cf85	2026-01-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021882 application number: NDA021882 ndc (product): 0078-0468 ndc (product): 0078-0470 ndc (product): 0078-0469

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 30 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0078-0468	Exjade	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0468	Exjade	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0468	Exjade	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0468	Exjade	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0468	Exjade	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0468	Exjade	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0468	Exjade	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0468	Exjade	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0468	Exjade	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0468	Exjade	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0469	Exjade	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0469	Exjade	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0469	Exjade	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0469	Exjade	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0469	Exjade	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0469	Exjade	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0469	Exjade	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0469	Exjade	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0469	Exjade	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0469	Exjade	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0470	Exjade	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0470	Exjade	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0470	Exjade	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0470	Exjade	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0470	Exjade	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0470	Exjade	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0470	Exjade	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0470	Exjade	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0470	Exjade	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0470	Exjade	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
73251	SUPPL	2023-01-19
73179	SUPPL	2023-01-17
64106	SUPPL	2020-07-27
64105	SUPPL	2020-07-27
64096	SUPPL	2020-07-27
64087	SUPPL	2020-07-24
59479	SUPPL	2019-07-29
59478	SUPPL	2019-07-29
59445	SUPPL	2019-07-29
58963	SUPPL	2019-06-04
58874	SUPPL	2019-05-29
56880	SUPPL	2018-12-20
56879	SUPPL	2018-12-20
56733	SUPPL	2018-12-14
56732	SUPPL	2018-12-14
54195	SUPPL	2018-05-15
54176	SUPPL	2018-05-14
52704	SUPPL	2018-02-23
52680	SUPPL	2018-02-22
45071	SUPPL	2016-08-17
45080	SUPPL	2016-08-12
16521	SUPPL	2015-07-24
6384	SUPPL	2015-07-24
6383	SUPPL	2013-10-22
37827	SUPPL	2013-10-21
16520	SUPPL	2013-06-04
28782	SUPPL	2013-05-31
28781	SUPPL	2013-01-25
6382	SUPPL	2013-01-25
37826	SUPPL	2013-01-24
37825	SUPPL	2012-09-20
28780	SUPPL	2012-09-18
6381	SUPPL	2011-08-12
16519	SUPPL	2011-08-11
28779	SUPPL	2011-04-13
37824	SUPPL	2011-04-11
28778	SUPPL	2010-02-05
37823	SUPPL	2010-02-04
16518	SUPPL	2009-04-28
6379	SUPPL	2009-04-27
6380	SUPPL	2009-03-10
16517	SUPPL	2008-10-09
6378	SUPPL	2008-10-08
28777	SUPPL	2008-01-09
37822	SUPPL	2008-01-08
28776	SUPPL	2007-05-01
16516	SUPPL	2007-04-25
21857	ORIG	2006-01-10
28775	ORIG	2005-11-08
37821	ORIG	2005-11-03
52607	SUPPL	1900-01-01
52606	SUPPL	1900-01-01
52605	SUPPL	1900-01-01