Application 208697

Type: ANDA
Sponsor: ACTAVIS ELIZABETH

Application Products#

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

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	Approval date
A208697-001	DEFERASIROX	DEFERASIROX	90MG	TABLET / ORAL	AB	2019-12-13
A208697-002	DEFERASIROX	DEFERASIROX	180MG	TABLET / ORAL	AB	2019-12-13
A208697-003	DEFERASIROX	DEFERASIROX	360MG	TABLET / ORAL	AB	2019-12-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208697-001	AB
A208697-002	AB
A208697-003	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 3 · 111 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A208697-001	DEFERASIROX	90MG	TABLET / ORAL	AB	2019-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208697-002	DEFERASIROX	180MG	TABLET / ORAL	AB	2019-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208697-003	DEFERASIROX	360MG	TABLET / ORAL	AB	2019-12-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208697-001	DEFERASIROX	90MG	TABLET / ORAL	AB	2019-12-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208697-002	DEFERASIROX	180MG	TABLET / ORAL	AB	2019-12-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208697-003	DEFERASIROX	360MG	TABLET / ORAL	AB	2019-12-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208697-001	DEFERASIROX	90MG	TABLET / ORAL	AB	2019-12-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208697-002	DEFERASIROX	180MG	TABLET / ORAL	AB	2019-12-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208697-003	DEFERASIROX	360MG	TABLET / ORAL	AB	2019-12-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208697-001	DEFERASIROX	90MG	TABLET / ORAL	AB	2019-12-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208697-002	DEFERASIROX	180MG	TABLET / ORAL	AB	2019-12-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208697-003	DEFERASIROX	360MG	TABLET / ORAL	AB	2019-12-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208697-001	DEFERASIROX	90MG	TABLET / ORAL	AB	2019-12-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208697-002	DEFERASIROX	180MG	TABLET / ORAL	AB	2019-12-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208697-003	DEFERASIROX	360MG	TABLET / ORAL	AB	2019-12-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208697-001	DEFERASIROX	90MG	TABLET / ORAL	AB	2019-12-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208697-002	DEFERASIROX	180MG	TABLET / ORAL	AB	2019-12-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208697-003	DEFERASIROX	360MG	TABLET / ORAL	AB	2019-12-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208697-001	DEFERASIROX	90MG	TABLET / ORAL	AB	2019-12-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208697-002	DEFERASIROX	180MG	TABLET / ORAL	AB	2019-12-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208697-003	DEFERASIROX	360MG	TABLET / ORAL	AB	2019-12-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208697-001	DEFERASIROX	90MG	TABLET / ORAL	AB	2019-12-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208697-002	DEFERASIROX	180MG	TABLET / ORAL	AB	2019-12-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208697-003	DEFERASIROX	360MG	TABLET / ORAL	AB	2019-12-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208697-001	DEFERASIROX	90MG	TABLET / ORAL	AB	2019-12-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208697-002	DEFERASIROX	180MG	TABLET / ORAL	AB	2019-12-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208697-003	DEFERASIROX	360MG	TABLET / ORAL	AB	2019-12-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208697-001	DEFERASIROX	90MG	TABLET / ORAL	AB	2019-12-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208697-002	DEFERASIROX	180MG	TABLET / ORAL	AB	2019-12-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208697-003	DEFERASIROX	360MG	TABLET / ORAL	AB	2019-12-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208697-001	DEFERASIROX	90MG	TABLET / ORAL	AB	2019-12-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208697-002	DEFERASIROX	180MG	TABLET / ORAL	AB	2019-12-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208697-003	DEFERASIROX	360MG	TABLET / ORAL	AB	2019-12-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208697-001	DEFERASIROX	90MG	TABLET / ORAL	AB	2019-12-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208697-002	DEFERASIROX	180MG	TABLET / ORAL	AB	2019-12-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208697-003	DEFERASIROX	360MG	TABLET / ORAL	AB	2019-12-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208697-001	DEFERASIROX	90MG	TABLET / ORAL	AB	2019-12-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208697-002	DEFERASIROX	180MG	TABLET / ORAL	AB	2019-12-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208697-003	DEFERASIROX	360MG	TABLET / ORAL	AB	2019-12-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208697-001	DEFERASIROX	90MG	TABLET / ORAL	AB	2019-12-13	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 111 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	A208697-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208697-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208697-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208697-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208697-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208697-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208697-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208697-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208697-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208697-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208697-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208697-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208697-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208697-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208697-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208697-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208697-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208697-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208697-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208697-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208697-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208697-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208697-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208697-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208697-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208697-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208697-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208697-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208697-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208697-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208697-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208697-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208697-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208697-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208697-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208697-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208697-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208697-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208697-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208697-001	AB	1	`8072bd15b7f6…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2020-12-22 03:56 UTC	2020-12	A208697-002	PC	2020-06-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208697-002	PC	2020-06-14	`c0c555d07b60…`

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 2 · 31 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	Name fallback generic name: DEFERASIROX
Deferasirox	DEFERASIROX	AvKARE	485c4834-7bec-2018-e063-6294a90ab4e3	2026-01-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Deferasirox generic name: DEFERASIROX
Deferasirox	DEFERASIROX	Novadoz Pharmaceuticals LLC	a03c7657-fdca-4acb-ad82-c24680e90eae	2025-12-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Deferasirox generic name: DEFERASIROX
Jadenu	DEFERASIROX	Novartis Pharmaceuticals Corporation	fee89140-fff1-4443-9f42-24ac004fcda1	2025-12-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DEFERASIROX
Deferasirox	DEFERASIROX	Actavis Pharma, Inc.	ad73cb1f-41d6-4cde-9abc-fc2cb7e04c95	2025-10-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Deferasirox generic name: DEFERASIROX
DEFERASIROX	DEFERASIROX	Aurobindo Pharma Limited	c220484e-1e6a-4a0c-a221-60223f3bc24c	2025-09-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DEFERASIROX generic name: DEFERASIROX
Deferasirox	DEFERASIROX	Ascend Laboratories, LLC	da3295fc-5210-46a3-a5cc-7b9ec9265eca	2025-07-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Deferasirox generic name: DEFERASIROX
Deferasirox	DEFERASIROX	Ascend Laboratories, LLC	0fb210b3-6a3d-4313-83ce-52012e384f9b	2025-06-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Deferasirox generic name: DEFERASIROX
Deferasirox	DEFERASIROX	Bionpharma Inc.	dc690f20-533e-490e-b13d-143382e02351	2025-03-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Deferasirox generic name: DEFERASIROX
Deferasirox	DEFERASIROX	Camber Pharmaceuticals, Inc.	65453013-c360-4835-8358-2a278a4a32db	2025-02-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Deferasirox generic name: DEFERASIROX
Deferasirox Oral Granules	DEFERASIROX	EPIC PHARMA, LLC	7eda83c3-a282-47f6-9f06-d2f9612f5c5b	2025-01-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DEFERASIROX
deferasirox	DEFERASIROX	Zydus Lifesciences Limited	fcd2ffe2-c8ba-400b-b7f9-e0e4b3510b98	2024-11-26		Name fallback brand name: deferasirox generic name: DEFERASIROX
deferasirox	DEFERASIROX	Glenmark Pharmaceuticals Inc., USA	59f1d3fb-5bdb-4261-8557-9a4bde8b3c1c	2024-11-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: deferasirox generic name: DEFERASIROX
Deferasirox	DEFERASIROX	Dr. Reddy's Laboratories Inc	350dfc39-d03d-e221-22e9-3880728c955c	2024-09-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Deferasirox generic name: DEFERASIROX
Deferasirox	DEFERASIROX	Xiromed, LLC	4c36bb5a-2552-46c1-8500-4ae783cffef1	2024-09-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Deferasirox generic name: DEFERASIROX
Deferasirox	DEFERASIROX	Teva Pharmaceuticals, Inc.	e9054806-2721-4736-9aef-81ffb8db75d1	2024-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Deferasirox generic name: DEFERASIROX
DEFERASIROX	DEFERASIROX	Aurobindo Pharma Limited	c7f14819-1abc-4abf-b55b-cf89beaf124e	2024-05-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DEFERASIROX generic name: DEFERASIROX
DEFERASIROX	DEFERASIROX	Camber Pharmaceuticals, Inc.	eded6687-ba78-4117-a316-eec56d46a08a	2024-05-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DEFERASIROX generic name: DEFERASIROX
DEFERASIROX	DEFERASIROX	NorthStar Rx LLC	57cf1650-88f9-474e-9e19-df451a15619d	2023-12-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DEFERASIROX generic name: DEFERASIROX
deferasirox	DEFERASIROX	Sun Pharmaceutical Industries, Inc.	4a2e1bd2-9f3a-40ec-94a2-bc76350d6d4b	2023-12-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: deferasirox generic name: DEFERASIROX

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0591-3853	Deferasirox	Deferasirox	Actavis Pharma, Inc.	ANDA	Current
0591-3853	Deferasirox	Deferasirox	Actavis Pharma, Inc.	ANDA	Current
0591-3853	Deferasirox	Deferasirox	Actavis Pharma, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
62172	ORIG	2020-03-17