Application 210727

Type: ANDA
Sponsor: AMNEAL

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 44.

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
A210727-001	DEFERASIROX	DEFERASIROX	90MG	TABLET / ORAL	2019-12-27
A210727-002	DEFERASIROX	DEFERASIROX	360MG	TABLET / ORAL	2019-12-27
A210727-003	DEFERASIROX	DEFERASIROX	180MG	TABLET / ORAL	2020-06-15

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 2 of 3 · 120 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
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210727-002	DEFERASIROX	360MG	TABLET / ORAL		2019-12-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210727-003	DEFERASIROX	180MG	TABLET / ORAL		2020-06-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210727-001	DEFERASIROX	90MG	TABLET / ORAL		2019-12-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210727-002	DEFERASIROX	360MG	TABLET / ORAL		2019-12-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210727-003	DEFERASIROX	180MG	TABLET / ORAL		2020-06-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210727-001	DEFERASIROX	90MG	TABLET / ORAL		2019-12-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210727-002	DEFERASIROX	360MG	TABLET / ORAL		2019-12-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210727-003	DEFERASIROX	180MG	TABLET / ORAL		2020-06-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210727-001	DEFERASIROX	90MG	TABLET / ORAL		2019-12-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210727-002	DEFERASIROX	360MG	TABLET / ORAL		2019-12-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210727-003	DEFERASIROX	180MG	TABLET / ORAL		2020-06-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210727-001	DEFERASIROX	90MG	TABLET / ORAL		2019-12-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210727-002	DEFERASIROX	360MG	TABLET / ORAL		2019-12-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210727-003	DEFERASIROX	180MG	TABLET / ORAL		2020-06-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210727-001	DEFERASIROX	90MG	TABLET / ORAL		2019-12-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210727-002	DEFERASIROX	360MG	TABLET / ORAL		2019-12-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210727-003	DEFERASIROX	180MG	TABLET / ORAL	AB	2020-06-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210727-001	DEFERASIROX	90MG	TABLET / ORAL		2019-12-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210727-002	DEFERASIROX	360MG	TABLET / ORAL		2019-12-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210727-003	DEFERASIROX	180MG	TABLET / ORAL	AB	2020-06-15	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210727-001	DEFERASIROX	90MG	TABLET / ORAL		2019-12-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210727-002	DEFERASIROX	360MG	TABLET / ORAL		2019-12-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210727-003	DEFERASIROX	180MG	TABLET / ORAL	AB	2020-06-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210727-001	DEFERASIROX	90MG	TABLET / ORAL	AB	2019-12-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210727-002	DEFERASIROX	360MG	TABLET / ORAL	AB	2019-12-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210727-003	DEFERASIROX	180MG	TABLET / ORAL	AB	2020-06-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210727-001	DEFERASIROX	90MG	TABLET / ORAL	AB	2019-12-27	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210727-002	DEFERASIROX	360MG	TABLET / ORAL	AB	2019-12-27	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210727-003	DEFERASIROX	180MG	TABLET / ORAL	AB	2020-06-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210727-001	DEFERASIROX	90MG	TABLET / ORAL	AB	2019-12-27	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A210727-002	DEFERASIROX	360MG	TABLET / ORAL	AB	2019-12-27	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A210727-003	DEFERASIROX	180MG	TABLET / ORAL	AB	2020-06-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210727-001	DEFERASIROX	90MG	TABLET / ORAL	AB	2019-12-27	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A210727-002	DEFERASIROX	360MG	TABLET / ORAL	AB	2019-12-27	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A210727-003	DEFERASIROX	180MG	TABLET / ORAL	AB	2020-06-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210727-001	DEFERASIROX	90MG	TABLET / ORAL	AB	2019-12-27	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A210727-002	DEFERASIROX	360MG	TABLET / ORAL	AB	2019-12-27	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A210727-003	DEFERASIROX	180MG	TABLET / ORAL	AB	2020-06-15	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210727-001	DEFERASIROX	90MG	TABLET / ORAL		2019-12-27	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210727-002	DEFERASIROX	360MG	TABLET / ORAL		2019-12-27	`6a51e52b5d6a…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-04-08 23:34 UTC	2022-04	A210727-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210727-003	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210727-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210727-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210727-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210727-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210727-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210727-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210727-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210727-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A210727-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A210727-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210727-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A210727-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A210727-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210727-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A210727-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A210727-003	AB	1	`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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Deferasirox	DEFERASIROX	Amneal Pharmaceuticals NY LLC	a7ae9c31-e14f-4cf9-9ab3-850519f1a87c	2020-10-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210727 application number: ANDA210727 ndc (product): 69238-1487 ndc (product): 69238-1486 ndc (product): 69238-1488

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 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69238-1486	Deferasirox	Deferasirox	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1486	Deferasirox	Deferasirox	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1486	Deferasirox	Deferasirox	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1486	Deferasirox	Deferasirox	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1487	Deferasirox	Deferasirox	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1487	Deferasirox	Deferasirox	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1487	Deferasirox	Deferasirox	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1488	Deferasirox	Deferasirox	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1488	Deferasirox	Deferasirox	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1488	Deferasirox	Deferasirox	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1488	Deferasirox	Deferasirox	Amneal Pharmaceuticals NY LLC	ANDA	Current