Application 214194

Type: ANDA
Sponsor: AMNEAL

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	Approval date
A214194-001	DEFERASIROX	DEFERASIROX	180MG	GRANULE / ORAL	2021-02-09
A214194-002	DEFERASIROX	DEFERASIROX	360MG	GRANULE / ORAL	2021-02-09
A214194-003	DEFERASIROX	DEFERASIROX	90MG	GRANULE / ORAL	2021-08-02

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 · 109 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A214194-001	DEFERASIROX	180MG	GRANULE / ORAL	2021-02-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214194-002	DEFERASIROX	360MG	GRANULE / ORAL	2021-02-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214194-003	DEFERASIROX	90MG	GRANULE / ORAL	2021-08-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214194-001	DEFERASIROX	180MG	GRANULE / ORAL	2021-02-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214194-002	DEFERASIROX	360MG	GRANULE / ORAL	2021-02-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214194-003	DEFERASIROX	90MG	GRANULE / ORAL	2021-08-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214194-001	DEFERASIROX	180MG	GRANULE / ORAL	2021-02-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214194-002	DEFERASIROX	360MG	GRANULE / ORAL	2021-02-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214194-003	DEFERASIROX	90MG	GRANULE / ORAL	2021-08-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214194-001	DEFERASIROX	180MG	GRANULE / ORAL	2021-02-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214194-002	DEFERASIROX	360MG	GRANULE / ORAL	2021-02-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214194-003	DEFERASIROX	90MG	GRANULE / ORAL	2021-08-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214194-001	DEFERASIROX	180MG	GRANULE / ORAL	2021-02-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214194-002	DEFERASIROX	360MG	GRANULE / ORAL	2021-02-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214194-003	DEFERASIROX	90MG	GRANULE / ORAL	2021-08-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214194-001	DEFERASIROX	180MG	GRANULE / ORAL	2021-02-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214194-002	DEFERASIROX	360MG	GRANULE / ORAL	2021-02-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214194-003	DEFERASIROX	90MG	GRANULE / ORAL	2021-08-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214194-001	DEFERASIROX	180MG	GRANULE / ORAL	2021-02-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214194-002	DEFERASIROX	360MG	GRANULE / ORAL	2021-02-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214194-003	DEFERASIROX	90MG	GRANULE / ORAL	2021-08-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214194-001	DEFERASIROX	180MG	GRANULE / ORAL	2021-02-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214194-002	DEFERASIROX	360MG	GRANULE / ORAL	2021-02-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214194-003	DEFERASIROX	90MG	GRANULE / ORAL	2021-08-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214194-001	DEFERASIROX	180MG	GRANULE / ORAL	2021-02-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214194-002	DEFERASIROX	360MG	GRANULE / ORAL	2021-02-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214194-003	DEFERASIROX	90MG	GRANULE / ORAL	2021-08-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214194-001	DEFERASIROX	180MG	GRANULE / ORAL	2021-02-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214194-002	DEFERASIROX	360MG	GRANULE / ORAL	2021-02-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214194-003	DEFERASIROX	90MG	GRANULE / ORAL	2021-08-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214194-001	DEFERASIROX	180MG	GRANULE / ORAL	2021-02-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214194-002	DEFERASIROX	360MG	GRANULE / ORAL	2021-02-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214194-003	DEFERASIROX	90MG	GRANULE / ORAL	2021-08-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214194-001	DEFERASIROX	180MG	GRANULE / ORAL	2021-02-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214194-002	DEFERASIROX	360MG	GRANULE / ORAL	2021-02-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214194-003	DEFERASIROX	90MG	GRANULE / ORAL	2021-08-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214194-001	DEFERASIROX	180MG	GRANULE / ORAL	2021-02-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214194-002	DEFERASIROX	360MG	GRANULE / ORAL	2021-02-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214194-003	DEFERASIROX	90MG	GRANULE / ORAL	2021-08-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214194-001	DEFERASIROX	180MG	GRANULE / ORAL	2021-02-09	`301d65b070ca…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214194-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214194-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214194-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A214194-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214194-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A214194-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A214194-003	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214194-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A214194-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A214194-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214194-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A214194-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A214194-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A214194-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A214194-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A214194-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A214194-002	AB	1	`5aa47cf7b7d7…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214194-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214194-002	AB	1	`cb3db0bc1861…`

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 2 of 2 · 31 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
deferasirox	DEFERASIROX	Zydus Pharmaceuticals USA Inc.	4af5bc9e-3e09-4dfd-8cc8-7677953c9c7c	2023-07-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: deferasirox generic name: DEFERASIROX
Deferasirox	DEFERASIROX	Alembic Pharmaceuticals Inc.	1f9f1a69-bf71-4e6a-88b0-90f08c4da79f	2023-03-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Deferasirox generic name: DEFERASIROX
DEFERASIROX	DEFERASIROX	Alembic Pharmaceuticals Inc.	f1f952c8-89f5-4a2f-bd6b-9b384366d971	2023-02-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DEFERASIROX generic name: DEFERASIROX
Deferasirox	DEFERASIROX	Alembic Pharmaceuticals Limited	8c8b84f3-6887-4485-b5e0-03f254b88a15	2023-01-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Deferasirox generic name: DEFERASIROX
DEFERASIROX	DEFERASIROX	Alembic Pharmaceuticals Limited	dd9450f4-7c95-4322-8806-9820570f5aa2	2023-01-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DEFERASIROX generic name: DEFERASIROX
Deferasorox	DEFERASIROX	Novadoz Pharmaceuticals LLC	1122f1c0-c160-49db-a31b-90d7521370f5	2022-05-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DEFERASIROX
Deferasirox	DEFERASIROX	Cipla USA Inc.	31c5a91f-e901-418b-a519-779a0c245477	2021-07-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Deferasirox generic name: DEFERASIROX
Deferasirox	DEFERASIROX	MSN LABORATORIES PRIVATE LIMITED	0354cbc7-9b32-4513-976a-2ef2da39b6b3	2021-01-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Deferasirox generic name: DEFERASIROX
Deferasirox	DEFERASIROX	Dr. Reddy's Laboratories Inc	e365e748-4b61-94f2-fb7a-f81919eaccaa	2020-12-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Deferasirox generic name: DEFERASIROX
Deferasirox	DEFERASIROX	MSN LABORATORIES PRIVATE LIMITED	e0726c9c-cee8-4fc1-abd1-68ad0db030dd	2020-12-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Deferasirox generic name: DEFERASIROX
Deferasirox	DEFERASIROX	Amneal Pharmaceuticals NY LLC	a7ae9c31-e14f-4cf9-9ab3-850519f1a87c	2020-10-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Deferasirox generic name: DEFERASIROX

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 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69238-1702	deferasirox	deferasirox	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1702	deferasirox	deferasirox	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1703	deferasirox	deferasirox	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1703	deferasirox	deferasirox	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1703	deferasirox	deferasirox	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1704	deferasirox	deferasirox	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1704	deferasirox	deferasirox	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1704	deferasirox	deferasirox	Amneal Pharmaceuticals NY LLC	ANDA	Current