Application 211383

Type: ANDA
Sponsor: ZYDUS PHARMS

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	360MG	No	No
003	DEFERASIROX	DEFERASIROX	TABLET;ORAL	180MG	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	TE codes	Approval date
A211383-001	DEFERASIROX	DEFERASIROX	90MG	TABLET / ORAL	AB	2019-11-20
A211383-002	DEFERASIROX	DEFERASIROX	360MG	TABLET / ORAL	AB	2019-11-20
A211383-003	DEFERASIROX	DEFERASIROX	180MG	TABLET / ORAL	AB	2020-06-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211383-001	AB
A211383-002	AB
A211383-003	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 · 119 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
2026-09-14 22:38:34	2026-08	A211383-001	DEFERASIROX	90MG	TABLET / ORAL	AB	2019-11-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211383-002	DEFERASIROX	360MG	TABLET / ORAL	AB	2019-11-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211383-003	DEFERASIROX	180MG	TABLET / ORAL	AB	2020-06-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211383-001	DEFERASIROX	90MG	TABLET / ORAL	AB	2019-11-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211383-002	DEFERASIROX	360MG	TABLET / ORAL	AB	2019-11-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211383-003	DEFERASIROX	180MG	TABLET / ORAL	AB	2020-06-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211383-001	DEFERASIROX	90MG	TABLET / ORAL	AB	2019-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211383-002	DEFERASIROX	360MG	TABLET / ORAL	AB	2019-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211383-003	DEFERASIROX	180MG	TABLET / ORAL	AB	2020-06-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211383-001	DEFERASIROX	90MG	TABLET / ORAL	AB	2019-11-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211383-002	DEFERASIROX	360MG	TABLET / ORAL	AB	2019-11-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211383-003	DEFERASIROX	180MG	TABLET / ORAL	AB	2020-06-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211383-001	DEFERASIROX	90MG	TABLET / ORAL	AB	2019-11-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211383-002	DEFERASIROX	360MG	TABLET / ORAL	AB	2019-11-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211383-003	DEFERASIROX	180MG	TABLET / ORAL	AB	2020-06-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211383-001	DEFERASIROX	90MG	TABLET / ORAL	AB	2019-11-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211383-002	DEFERASIROX	360MG	TABLET / ORAL	AB	2019-11-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211383-003	DEFERASIROX	180MG	TABLET / ORAL	AB	2020-06-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211383-001	DEFERASIROX	90MG	TABLET / ORAL	AB	2019-11-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211383-002	DEFERASIROX	360MG	TABLET / ORAL	AB	2019-11-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211383-003	DEFERASIROX	180MG	TABLET / ORAL	AB	2020-06-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211383-001	DEFERASIROX	90MG	TABLET / ORAL	AB	2019-11-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211383-002	DEFERASIROX	360MG	TABLET / ORAL	AB	2019-11-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211383-003	DEFERASIROX	180MG	TABLET / ORAL	AB	2020-06-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211383-001	DEFERASIROX	90MG	TABLET / ORAL	AB	2019-11-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211383-002	DEFERASIROX	360MG	TABLET / ORAL	AB	2019-11-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211383-003	DEFERASIROX	180MG	TABLET / ORAL	AB	2020-06-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211383-001	DEFERASIROX	90MG	TABLET / ORAL	AB	2019-11-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211383-002	DEFERASIROX	360MG	TABLET / ORAL	AB	2019-11-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211383-003	DEFERASIROX	180MG	TABLET / ORAL	AB	2020-06-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211383-001	DEFERASIROX	90MG	TABLET / ORAL	AB	2019-11-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211383-002	DEFERASIROX	360MG	TABLET / ORAL	AB	2019-11-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211383-003	DEFERASIROX	180MG	TABLET / ORAL	AB	2020-06-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211383-001	DEFERASIROX	90MG	TABLET / ORAL	AB	2019-11-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211383-002	DEFERASIROX	360MG	TABLET / ORAL	AB	2019-11-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211383-003	DEFERASIROX	180MG	TABLET / ORAL	AB	2020-06-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211383-001	DEFERASIROX	90MG	TABLET / ORAL	AB	2019-11-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211383-002	DEFERASIROX	360MG	TABLET / ORAL	AB	2019-11-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211383-003	DEFERASIROX	180MG	TABLET / ORAL	AB	2020-06-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211383-001	DEFERASIROX	90MG	TABLET / ORAL	AB	2019-11-20	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 119 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A211383-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211383-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211383-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211383-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211383-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211383-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211383-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211383-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211383-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211383-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211383-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211383-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211383-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211383-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211383-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211383-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211383-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211383-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211383-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211383-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211383-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211383-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211383-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211383-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211383-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211383-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211383-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211383-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211383-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211383-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211383-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211383-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211383-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211383-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211383-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211383-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211383-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211383-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211383-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211383-001	AB	1	`301d65b070ca…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
deferasirox	DEFERASIROX	Zydus Lifesciences Limited	fcd2ffe2-c8ba-400b-b7f9-e0e4b3510b98	2024-11-26		Exact identifier application applno (ANDA): 211383 application number: ANDA211383 ndc (product): 70771-1472 ndc (product): 70771-1473 ndc (product): 70771-1471
deferasirox	DEFERASIROX	Zydus Pharmaceuticals USA Inc.	4af5bc9e-3e09-4dfd-8cc8-7677953c9c7c	2023-07-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211383 application number: ANDA211383 ndc (product): 70710-1275 ndc (product): 70710-1276 ndc (product): 70710-1277

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 · 47 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-993	deferasirox	deferasirox	Northstar Rx LLC.	ANDA	Current
16714-993	deferasirox	deferasirox	Northstar Rx LLC.	ANDA	Current
16714-993	deferasirox	deferasirox	Northstar Rx LLC.	ANDA	Current
16714-993	deferasirox	deferasirox	Northstar Rx LLC.	ANDA	Current
16714-993	deferasirox	deferasirox	Northstar Rx LLC.	ANDA	Current
16714-994	deferasirox	deferasirox	Northstar Rx LLC.	ANDA	Current
16714-994	deferasirox	deferasirox	Northstar Rx LLC.	ANDA	Current
16714-994	deferasirox	deferasirox	Northstar Rx LLC.	ANDA	Current
16714-994	deferasirox	deferasirox	Northstar Rx LLC.	ANDA	Current
16714-995	deferasirox	deferasirox	Northstar Rx LLC.	ANDA	Current
16714-995	deferasirox	deferasirox	Northstar Rx LLC.	ANDA	Current
16714-995	deferasirox	deferasirox	Northstar Rx LLC.	ANDA	Current
16714-995	deferasirox	deferasirox	Northstar Rx LLC.	ANDA	Current
16714-995	deferasirox	deferasirox	Northstar Rx LLC.	ANDA	Current
70710-1275	deferasirox	deferasirox	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1275	deferasirox	deferasirox	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1275	deferasirox	deferasirox	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1275	deferasirox	deferasirox	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1275	deferasirox	deferasirox	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1275	deferasirox	deferasirox	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1275	deferasirox	deferasirox	Zydus Pharmaceuticals USA Inc.	ANDA	Current
70710-1275	deferasirox	deferasirox	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1276	deferasirox	deferasirox	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1276	deferasirox	deferasirox	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1276	deferasirox	deferasirox	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1276	deferasirox	deferasirox	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1276	deferasirox	deferasirox	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1276	deferasirox	deferasirox	Zydus Pharmaceuticals USA Inc.	ANDA	Current
70710-1277	deferasirox	deferasirox	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1277	deferasirox	deferasirox	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1277	deferasirox	deferasirox	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1277	deferasirox	deferasirox	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1277	deferasirox	deferasirox	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1277	deferasirox	deferasirox	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1277	deferasirox	deferasirox	Zydus Pharmaceuticals USA Inc.	ANDA	Current
70710-1277	deferasirox	deferasirox	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70771-1471	deferasirox	deferasirox	Cadila Healthcare Limited	ANDA	Current
70771-1471	deferasirox	deferasirox	Zydus Lifesciences Limited	ANDA	Current
70771-1471	deferasirox	deferasirox	Cadila Healthcare Limited	ANDA	Current
70771-1471	deferasirox	deferasirox	Cadila Healthcare Limited	ANDA	Current
70771-1472	deferasirox	deferasirox	Cadila Healthcare Limited	ANDA	Current
70771-1472	deferasirox	deferasirox	Zydus Lifesciences Limited	ANDA	Current
70771-1472	deferasirox	deferasirox	Cadila Healthcare Limited	ANDA	Current
70771-1473	deferasirox	deferasirox	Cadila Healthcare Limited	ANDA	Current
70771-1473	deferasirox	deferasirox	Zydus Lifesciences Limited	ANDA	Current
70771-1473	deferasirox	deferasirox	Cadila Healthcare Limited	ANDA	Current
70771-1473	deferasirox	deferasirox	Cadila Healthcare Limited	ANDA	Current