Application 210519

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, FOR SUSPENSION;ORAL	125MG	No	No
002	DEFERASIROX	DEFERASIROX	TABLET, FOR SUSPENSION;ORAL	250MG	No	No
003	DEFERASIROX	DEFERASIROX	TABLET, FOR SUSPENSION;ORAL	500MG	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
A210519-001	DEFERASIROX	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20
A210519-002	DEFERASIROX	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20
A210519-003	DEFERASIROX	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210519-001	AB
A210519-002	AB
A210519-003	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 · 114 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	A210519-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210519-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210519-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210519-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210519-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210519-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210519-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210519-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210519-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210519-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210519-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210519-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210519-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210519-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210519-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210519-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210519-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210519-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210519-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210519-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210519-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210519-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210519-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210519-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210519-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210519-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210519-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210519-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210519-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210519-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210519-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210519-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210519-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210519-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210519-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210519-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210519-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210519-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210519-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210519-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 114 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	A210519-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210519-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210519-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210519-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210519-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210519-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210519-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210519-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210519-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210519-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210519-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210519-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210519-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210519-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210519-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210519-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210519-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210519-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210519-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210519-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210519-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210519-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210519-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210519-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210519-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210519-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210519-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210519-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210519-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210519-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210519-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210519-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210519-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210519-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210519-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210519-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210519-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210519-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210519-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210519-001	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	da3295fc-5210-46a3-a5cc-7b9ec9265eca	2025-07-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210519 application number: ANDA210519 ndc (product): 67877-549 ndc (product): 67877-550 ndc (product): 67877-551

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
67877-549	Deferasirox	Deferasirox	Ascend Laboratories, LLC	ANDA	Current
67877-549	Deferasirox	Deferasirox	Ascend Laboratories, LLC	ANDA	Current
67877-549	Deferasirox	Deferasirox	Ascend Laboratories, LLC	ANDA	Current
67877-550	Deferasirox	Deferasirox	Ascend Laboratories, LLC	ANDA	Current
67877-550	Deferasirox	Deferasirox	Ascend Laboratories, LLC	ANDA	Current
67877-550	Deferasirox	Deferasirox	Ascend Laboratories, LLC	ANDA	Current
67877-551	Deferasirox	Deferasirox	Ascend Laboratories, LLC	ANDA	Current
67877-551	Deferasirox	Deferasirox	Ascend Laboratories, LLC	ANDA	Current
67877-551	Deferasirox	Deferasirox	Ascend Laboratories, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
61214	ORIG	2019-12-10