Application 203565

Type: NDA
Sponsor: AM REGENT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	INJECTAFER	FERRIC CARBOXYMALTOSE	INJECTABLE;INTRAVENOUS	750MG IRON/15ML (50MG IRON/ML)	Yes	Yes
002	INJECTAFER	FERRIC CARBOXYMALTOSE	SOLUTION;INTRAVENOUS	500MG IRON/10ML (50MG IRON/ML)	Yes	Yes
003	INJECTAFER	FERRIC CARBOXYMALTOSE	SOLUTION;INTRAVENOUS	1GM IRON/20ML (50MG IRON/ML)	Yes	Yes
004	INJECTAFER	FERRIC CARBOXYMALTOSE	SOLUTION;INTRAVENOUS	100MG IRON/2ML (50MG IRON/ML)	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N203565-001	INJECTAFER	FERRIC CARBOXYMALTOSE	750MG IRON/15ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-07-25
N203565-002	INJECTAFER	FERRIC CARBOXYMALTOSE	500MG IRON/10ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-10-08
N203565-003	INJECTAFER	FERRIC CARBOXYMALTOSE	1GM IRON/20ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-04-28
N203565-004	INJECTAFER	FERRIC CARBOXYMALTOSE	100MG IRON/2ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2022-02-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N203565-001	AP
N203565-003	AP
N203565-004	AP

Orange Book patents#

Current patent rows page 1 of 2 · 90 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N203565-001	11364260	2027-01-08	U-3637		2023-06-28
N203565-001	11433091	2027-01-08	U-3435		2022-10-04
N203565-001	11433091	2027-01-08	U-3436		2022-10-04
N203565-001	11433091	2027-01-08	U-3437		2022-10-04
N203565-001	11433091	2027-01-08	U-3438		2022-10-04
N203565-001	11433091	2027-01-08	U-3634		2022-10-04
N203565-001	11478502	2027-01-08	U-3472		2022-11-21
N203565-001	11478502	2027-01-08	U-3473		2022-11-21
N203565-001	11478502	2027-01-08	U-3474		2022-11-21
N203565-001	8895612	2027-01-08	U-1620		2014-12-17
N203565-001	8895612	2027-01-08	U-3115		2014-12-17
N203565-001	8895612	2027-01-08	U-3116		2014-12-17
N203565-001	8895612	2027-01-08	U-3315		2014-12-17
N203565-001	8895612	2027-01-08	U-3316		2014-12-17
N203565-001	8895612	2027-01-08	U-3635		2014-12-17
N203565-001	7612109	2027-02-05		Drug substance, Drug product	2013-09-12
N203565-001	7754702	2028-02-15	U-1432		2013-09-12
N203565-001	7754702	2028-02-15	U-3312		2013-09-12
N203565-001	7754702	2028-02-15	U-3313		2013-09-12
N203565-001	7754702	2028-02-15	U-3314		2013-09-12
N203565-001	7754702	2028-02-15	U-3636		2013-09-12
N203565-002	11364260	2027-01-08	U-3637		2023-06-28
N203565-002	11433091	2027-01-08	U-3435		2022-10-04
N203565-002	11433091	2027-01-08	U-3436		2022-10-04
N203565-002	11433091	2027-01-08	U-3437		2022-10-04
N203565-002	11433091	2027-01-08	U-3438		2022-10-04
N203565-002	11433091	2027-01-08	U-3634		2022-10-04
N203565-002	11478502	2027-01-08	U-3472		2022-11-21
N203565-002	11478502	2027-01-08	U-3473		2022-11-21
N203565-002	11478502	2027-01-08	U-3474		2022-11-21
N203565-002	8895612	2027-01-08	U-1620		2021-02-02
N203565-002	8895612	2027-01-08	U-3050		2021-02-02
N203565-002	8895612	2027-01-08	U-3051		2021-02-02
N203565-002	8895612	2027-01-08	U-3115		2021-02-02
N203565-002	8895612	2027-01-08	U-3116		2021-02-02
N203565-002	8895612	2027-01-08	U-3315		2021-02-02
N203565-002	8895612	2027-01-08	U-3316		2021-02-02
N203565-002	8895612	2027-01-08	U-3635		2021-02-02
N203565-002	7612109	2027-02-05		Drug substance, Drug product	2021-02-02
N203565-002	7754702	2028-02-15	U-2555		2021-02-02
N203565-002	7754702	2028-02-15	U-2556		2021-02-02
N203565-002	7754702	2028-02-15	U-2557		2021-02-02
N203565-002	7754702	2028-02-15	U-3312		2021-02-02
N203565-002	7754702	2028-02-15	U-3313		2021-02-02
N203565-002	7754702	2028-02-15	U-3314		2021-02-02
N203565-002	7754702	2028-02-15	U-3636		2021-02-02
N203565-003	11364260	2027-01-08	U-3637		2023-06-28
N203565-003	11433091	2027-01-08	U-3435		2022-10-04
N203565-003	11433091	2027-01-08	U-3436		2022-10-04
N203565-003	11433091	2027-01-08	U-3437		2022-10-04
N203565-003	11433091	2027-01-08	U-3438		2022-10-04
N203565-003	11433091	2027-01-08	U-3634		2022-10-04
N203565-003	11478502	2027-01-08	U-3472		2022-11-21
N203565-003	11478502	2027-01-08	U-3473		2022-11-21
N203565-003	11478502	2027-01-08	U-3474		2022-11-21
N203565-003	8895612	2027-01-08	U-1620		2021-05-21
N203565-003	8895612	2027-01-08	U-3050		2021-05-21
N203565-003	8895612	2027-01-08	U-3051		2021-05-21
N203565-003	8895612	2027-01-08	U-3115		2021-05-21
N203565-003	8895612	2027-01-08	U-3116		2021-05-21
N203565-003	8895612	2027-01-08	U-3315		2021-05-21
N203565-003	8895612	2027-01-08	U-3316		2021-05-21
N203565-003	8895612	2027-01-08	U-3635		2021-05-21
N203565-003	7612109	2027-02-05		Drug substance, Drug product	2021-05-21
N203565-003	7754702	2028-02-15	U-2555		2021-05-21
N203565-003	7754702	2028-02-15	U-2556		2021-05-21
N203565-003	7754702	2028-02-15	U-2557		2021-05-21
N203565-003	7754702	2028-02-15	U-3312		2021-05-21
N203565-003	7754702	2028-02-15	U-3313		2021-05-21
N203565-003	7754702	2028-02-15	U-3314		2021-05-21
N203565-003	7754702	2028-02-15	U-3636		2021-05-21
N203565-004	11364260	2027-01-08	U-3637		2023-06-28
N203565-004	11433091	2027-01-08	U-3435		2022-10-04
N203565-004	11433091	2027-01-08	U-3436		2022-10-04
N203565-004	11433091	2027-01-08	U-3437		2022-10-04
N203565-004	11433091	2027-01-08	U-3438		2022-10-04
N203565-004	11433091	2027-01-08	U-3634		2022-10-04
N203565-004	11478502	2027-01-08	U-3472		2022-11-21
N203565-004	11478502	2027-01-08	U-3473		2022-11-21
N203565-004	11478502	2027-01-08	U-3474		2022-11-21

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 4 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N203565-001	I-915	2026-05-31
N203565-002	I-915	2026-05-31
N203565-003	I-915	2026-05-31
N203565-004	I-915	2026-05-31

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 4 · 145 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N203565-001	INJECTAFER	750MG IRON/15ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-07-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-002	INJECTAFER	500MG IRON/10ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-10-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-003	INJECTAFER	1GM IRON/20ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-04-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-004	INJECTAFER	100MG IRON/2ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2022-02-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N203565-001	INJECTAFER	750MG IRON/15ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2013-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203565-002	INJECTAFER	500MG IRON/10ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203565-003	INJECTAFER	1GM IRON/20ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203565-004	INJECTAFER	100MG IRON/2ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2022-02-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203565-001	INJECTAFER	750MG IRON/15ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2013-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203565-002	INJECTAFER	500MG IRON/10ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203565-003	INJECTAFER	1GM IRON/20ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203565-004	INJECTAFER	100MG IRON/2ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2022-02-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203565-001	INJECTAFER	750MG IRON/15ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2013-07-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203565-002	INJECTAFER	500MG IRON/10ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203565-003	INJECTAFER	1GM IRON/20ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203565-004	INJECTAFER	100MG IRON/2ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2022-02-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203565-001	INJECTAFER	750MG IRON/15ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2013-07-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203565-002	INJECTAFER	500MG IRON/10ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-10-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203565-003	INJECTAFER	1GM IRON/20ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203565-004	INJECTAFER	100MG IRON/2ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2022-02-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203565-001	INJECTAFER	750MG IRON/15ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2013-07-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203565-002	INJECTAFER	500MG IRON/10ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-10-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203565-003	INJECTAFER	1GM IRON/20ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-04-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203565-004	INJECTAFER	100MG IRON/2ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2022-02-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203565-001	INJECTAFER	750MG IRON/15ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2013-07-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203565-002	INJECTAFER	500MG IRON/10ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-10-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203565-003	INJECTAFER	1GM IRON/20ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-04-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203565-004	INJECTAFER	100MG IRON/2ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2022-02-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203565-001	INJECTAFER	750MG IRON/15ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2013-07-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203565-002	INJECTAFER	500MG IRON/10ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-10-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203565-003	INJECTAFER	1GM IRON/20ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-04-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203565-004	INJECTAFER	100MG IRON/2ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2022-02-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203565-001	INJECTAFER	750MG IRON/15ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2013-07-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203565-002	INJECTAFER	500MG IRON/10ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-10-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203565-003	INJECTAFER	1GM IRON/20ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-04-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203565-004	INJECTAFER	100MG IRON/2ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2022-02-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203565-001	INJECTAFER	750MG IRON/15ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2013-07-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203565-002	INJECTAFER	500MG IRON/10ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-10-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203565-003	INJECTAFER	1GM IRON/20ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-04-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203565-004	INJECTAFER	100MG IRON/2ML (50MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2022-02-04	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N203565-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-003	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-004	AP	1	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N203565-001	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N203565-003	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N203565-004	AP	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 82 · 3,245 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N203565-001	11364260	2027-01-08	U-3637		2023-06-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-001	11433091	2027-01-08	U-3435		2022-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-001	11433091	2027-01-08	U-3436		2022-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-001	11433091	2027-01-08	U-3437		2022-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-001	11433091	2027-01-08	U-3438		2022-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-001	11433091	2027-01-08	U-3634		2022-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-001	11478502	2027-01-08	U-3472		2022-11-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-001	11478502	2027-01-08	U-3473		2022-11-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-001	11478502	2027-01-08	U-3474		2022-11-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-001	8895612	2027-01-08	U-1620		2014-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-001	8895612	2027-01-08	U-3115		2014-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-001	8895612	2027-01-08	U-3116		2014-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-001	8895612	2027-01-08	U-3635		2014-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-001	8895612	2027-01-08	U-3315		2014-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-001	8895612	2027-01-08	U-3316		2014-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-001	7612109	2027-02-05		Drug substance, Drug product	2013-09-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-001	7754702	2028-02-15	U-1432		2013-09-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-001	7754702	2028-02-15	U-3636		2013-09-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-001	7754702	2028-02-15	U-3314		2013-09-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-001	7754702	2028-02-15	U-3312		2013-09-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-001	7754702	2028-02-15	U-3313		2013-09-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-002	11364260	2027-01-08	U-3637		2023-06-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-002	11433091	2027-01-08	U-3435		2022-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-002	11433091	2027-01-08	U-3436		2022-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-002	11433091	2027-01-08	U-3437		2022-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-002	11433091	2027-01-08	U-3438		2022-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-002	11433091	2027-01-08	U-3634		2022-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-002	11478502	2027-01-08	U-3472		2022-11-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-002	11478502	2027-01-08	U-3473		2022-11-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-002	11478502	2027-01-08	U-3474		2022-11-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-002	8895612	2027-01-08	U-3051		2021-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-002	8895612	2027-01-08	U-1620		2021-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-002	8895612	2027-01-08	U-3050		2021-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-002	8895612	2027-01-08	U-3116		2021-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-002	8895612	2027-01-08	U-3115		2021-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-002	8895612	2027-01-08	U-3635		2021-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-002	8895612	2027-01-08	U-3316		2021-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-002	8895612	2027-01-08	U-3315		2021-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-002	7612109	2027-02-05		Drug substance, Drug product	2021-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-002	7754702	2028-02-15	U-2556		2021-02-02	`caaa826d4ba7…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 5 · 189 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N203565-001	I-915	2026-05-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-002	I-915	2026-05-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-003	I-915	2026-05-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203565-004	I-915	2026-05-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N203565-001	I-915	2026-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203565-002	I-915	2026-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203565-003	I-915	2026-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203565-004	I-915	2026-05-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203565-001	I-915	2026-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203565-002	I-915	2026-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203565-003	I-915	2026-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203565-004	I-915	2026-05-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203565-001	I-915	2026-05-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203565-002	I-915	2026-05-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203565-003	I-915	2026-05-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203565-004	I-915	2026-05-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203565-001	I-915	2026-05-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203565-002	I-915	2026-05-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203565-003	I-915	2026-05-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203565-004	I-915	2026-05-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203565-001	I-915	2026-05-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203565-002	I-915	2026-05-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203565-003	I-915	2026-05-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203565-004	I-915	2026-05-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203565-001	NPP	2024-11-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203565-001	I-915	2026-05-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203565-002	NPP	2024-11-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203565-002	I-915	2026-05-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203565-003	NS	2024-04-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203565-003	NPP	2024-11-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203565-003	I-915	2026-05-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203565-004	I-915	2026-05-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203565-001	NPP	2024-11-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203565-001	I-915	2026-05-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203565-002	NPP	2024-11-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203565-002	I-915	2026-05-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203565-003	NS	2024-04-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203565-003	NPP	2024-11-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203565-003	I-915	2026-05-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203565-004	I-915	2026-05-31	`2680178bc6a6…`

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
Injectafer	FERRIC CARBOXYMALTOSE INJECTION	American Regent, Inc.	517b4a19-45b3-4286-9f6a-ced4e10447de	2026-08-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 203565 application number: NDA203565 ndc (product): 0517-0650 ndc (product): 0517-0620 ndc (product): 0517-0602
Ferric Carboxymaltose	FERRIC CARBOXYMALTOSE INJECTION	Sandoz, Inc.	bfdf7447-62e4-48ca-b903-11cb3b211064	2026-02-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203565 application number: NDA203565

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 17 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0517-0602	Injectafer	Ferric Carboxymaltose Injection	American Regent, Inc.	NDA	Current
0517-0602	Injectafer	Ferric Carboxymaltose Injection	American Regent, Inc.	NDA	Current
0517-0620	Injectafer	Ferric Carboxymaltose	American Regent, Inc.	NDA	Current
0517-0620	Injectafer	Ferric Carboxymaltose	American Regent, Inc.	NDA	Current
0517-0620	Injectafer	Ferric Carboxymaltose	American Regent, Inc.	NDA	Current
0517-0620	Injectafer	Ferric Carboxymaltose	American Regent, Inc.	NDA	Current
0517-0620	Injectafer	Ferric Carboxymaltose	American Regent, Inc.	NDA	Current
0517-0650	Injectafer	Ferric Carboxymaltose Injection	American Regent, Inc.	NDA	Current
0517-0650	Injectafer	Ferric Carboxymaltose Injection	American Regent, Inc.	NDA	Current
0517-0650	Injectafer	Ferric Carboxymaltose Injection	American Regent, Inc.	NDA	Current
0517-0650	Injectafer	Ferric Carboxymaltose Injection	American Regent, Inc.	NDA	Current
0517-0650	Injectafer	Ferric Carboxymaltose Injection	American Regent, Inc.	NDA	Current
0517-0650	Injectafer	Ferric Carboxymaltose Injection	American Regent, Inc.	NDA	Current
0517-0650	Injectafer	Ferric Carboxymaltose Injection	American Regent, Inc.	NDA	Current
0517-0650	Injectafer	Ferric Carboxymaltose Injection	American Regent, Inc.	NDA	Current
0517-0650	Injectafer	Ferric Carboxymaltose Injection	American Regent, Inc.	NDA	Current
0517-0650	Injectafer	Ferric Carboxymaltose Injection	American Regent, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80815	SUPPL	2025-01-06
80812	SUPPL	2025-01-03
74423	SUPPL	2023-06-01
74422	SUPPL	2023-06-01
74419	SUPPL	2023-06-01
74418	SUPPL	2023-06-01
71604	SUPPL	2022-07-20
71603	SUPPL	2022-07-19
69388	SUPPL	2021-11-23
69363	SUPPL	2021-11-22
68542	SUPPL	2021-09-03
68294	SUPPL	2021-08-05
67385	SUPPL	2021-05-04
67278	SUPPL	2021-04-30
66313	SUPPL	2021-02-22
66205	SUPPL	2021-02-12
64575	SUPPL	2020-09-15
64572	SUPPL	2020-09-14
61920	SUPPL	2020-02-20
61919	SUPPL	2020-02-20
56171	SUPPL	2018-10-30
56114	SUPPL	2018-10-26
52120	SUPPL	2018-01-30
52118	SUPPL	2018-01-30
44886	ORIG	2013-09-04
22927	ORIG	2013-09-04
40312	ORIG	2013-07-30
10233	ORIG	2013-07-29