Application 210555

Type: ANDA
Sponsor: ALKEM LABS LTD

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 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
A210555-001	DEFERASIROX	DEFERASIROX	90MG	TABLET / ORAL	AB	2020-03-30
A210555-002	DEFERASIROX	DEFERASIROX	360MG	TABLET / ORAL	AB	2020-03-30
A210555-003	DEFERASIROX	DEFERASIROX	180MG	TABLET / ORAL	AB	2020-07-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210555-001	AB
A210555-002	AB
A210555-003	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	A210555-001	DEFERASIROX	90MG	TABLET / ORAL	AB	2020-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210555-002	DEFERASIROX	360MG	TABLET / ORAL	AB	2020-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210555-003	DEFERASIROX	180MG	TABLET / ORAL	AB	2020-07-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210555-001	DEFERASIROX	90MG	TABLET / ORAL	AB	2020-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210555-002	DEFERASIROX	360MG	TABLET / ORAL	AB	2020-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210555-003	DEFERASIROX	180MG	TABLET / ORAL	AB	2020-07-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210555-001	DEFERASIROX	90MG	TABLET / ORAL	AB	2020-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210555-002	DEFERASIROX	360MG	TABLET / ORAL	AB	2020-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210555-003	DEFERASIROX	180MG	TABLET / ORAL	AB	2020-07-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210555-001	DEFERASIROX	90MG	TABLET / ORAL	AB	2020-03-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210555-002	DEFERASIROX	360MG	TABLET / ORAL	AB	2020-03-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210555-003	DEFERASIROX	180MG	TABLET / ORAL	AB	2020-07-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210555-001	DEFERASIROX	90MG	TABLET / ORAL	AB	2020-03-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210555-002	DEFERASIROX	360MG	TABLET / ORAL	AB	2020-03-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210555-003	DEFERASIROX	180MG	TABLET / ORAL	AB	2020-07-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210555-001	DEFERASIROX	90MG	TABLET / ORAL	AB	2020-03-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210555-002	DEFERASIROX	360MG	TABLET / ORAL	AB	2020-03-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210555-003	DEFERASIROX	180MG	TABLET / ORAL	AB	2020-07-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210555-001	DEFERASIROX	90MG	TABLET / ORAL	AB	2020-03-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210555-002	DEFERASIROX	360MG	TABLET / ORAL	AB	2020-03-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210555-003	DEFERASIROX	180MG	TABLET / ORAL	AB	2020-07-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210555-001	DEFERASIROX	90MG	TABLET / ORAL	AB	2020-03-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210555-002	DEFERASIROX	360MG	TABLET / ORAL	AB	2020-03-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210555-003	DEFERASIROX	180MG	TABLET / ORAL	AB	2020-07-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210555-001	DEFERASIROX	90MG	TABLET / ORAL	AB	2020-03-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210555-002	DEFERASIROX	360MG	TABLET / ORAL	AB	2020-03-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210555-003	DEFERASIROX	180MG	TABLET / ORAL	AB	2020-07-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210555-001	DEFERASIROX	90MG	TABLET / ORAL	AB	2020-03-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210555-002	DEFERASIROX	360MG	TABLET / ORAL	AB	2020-03-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210555-003	DEFERASIROX	180MG	TABLET / ORAL	AB	2020-07-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210555-001	DEFERASIROX	90MG	TABLET / ORAL	AB	2020-03-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210555-002	DEFERASIROX	360MG	TABLET / ORAL	AB	2020-03-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210555-003	DEFERASIROX	180MG	TABLET / ORAL	AB	2020-07-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210555-001	DEFERASIROX	90MG	TABLET / ORAL	AB	2020-03-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210555-002	DEFERASIROX	360MG	TABLET / ORAL	AB	2020-03-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210555-003	DEFERASIROX	180MG	TABLET / ORAL	AB	2020-07-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210555-001	DEFERASIROX	90MG	TABLET / ORAL	AB	2020-03-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210555-002	DEFERASIROX	360MG	TABLET / ORAL	AB	2020-03-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210555-003	DEFERASIROX	180MG	TABLET / ORAL	AB	2020-07-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210555-001	DEFERASIROX	90MG	TABLET / ORAL	AB	2020-03-30	`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	A210555-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210555-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210555-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210555-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210555-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210555-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210555-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210555-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210555-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210555-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210555-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210555-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210555-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210555-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210555-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210555-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210555-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210555-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210555-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210555-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210555-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210555-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210555-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210555-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210555-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210555-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210555-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210555-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210555-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210555-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210555-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210555-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210555-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210555-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210555-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210555-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210555-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210555-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210555-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210555-001	AB	1	`8072bd15b7f6…`

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
Deferasirox	DEFERASIROX	Ascend Laboratories, LLC	0fb210b3-6a3d-4313-83ce-52012e384f9b	2025-06-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210555 application number: ANDA210555 ndc (product): 67877-554 ndc (product): 67877-552 ndc (product): 67877-553

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
67877-552	Deferasirox	Deferasirox	Ascend Laboratories, LLC	ANDA	Current
67877-552	Deferasirox	Deferasirox	Ascend Laboratories, LLC	ANDA	Current
67877-552	Deferasirox	Deferasirox	Ascend Laboratories, LLC	ANDA	Current
67877-552	Deferasirox	Deferasirox	Ascend Laboratories, LLC	ANDA	Current
67877-552	Deferasirox	Deferasirox	Ascend Laboratories, LLC	ANDA	Current
67877-553	Deferasirox	Deferasirox	Ascend Laboratories, LLC	ANDA	Current
67877-553	Deferasirox	Deferasirox	Ascend Laboratories, LLC	ANDA	Current
67877-553	Deferasirox	Deferasirox	Ascend Laboratories, LLC	ANDA	Current
67877-553	Deferasirox	Deferasirox	Ascend Laboratories, LLC	ANDA	Current
67877-554	Deferasirox	Deferasirox	Ascend Laboratories, LLC	ANDA	Current
67877-554	Deferasirox	Deferasirox	Ascend Laboratories, LLC	ANDA	Current
67877-554	Deferasirox	Deferasirox	Ascend Laboratories, LLC	ANDA	Current
67877-554	Deferasirox	Deferasirox	Ascend Laboratories, LLC	ANDA	Current
67877-554	Deferasirox	Deferasirox	Ascend Laboratories, LLC	ANDA	Current