Application 040024

Type: NDA
Sponsor: AM REGENT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEXFERRUM	IRON DEXTRAN	INJECTABLE;INJECTION	EQ 50MG IRON/ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N040024-001	DEXFERRUM	IRON DEXTRAN	EQ 50MG IRON/ML	INJECTABLE / INJECTION			1996-02-23

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 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N040024-001	DEXFERRUM	EQ 50MG IRON/ML	INJECTABLE / INJECTION	1996-02-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N040024-001	DEXFERRUM	EQ 50MG IRON/ML	INJECTABLE / INJECTION	1996-02-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N040024-001	DEXFERRUM	EQ 50MG IRON/ML	INJECTABLE / INJECTION	1996-02-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N040024-001	DEXFERRUM	EQ 50MG IRON/ML	INJECTABLE / INJECTION	1996-02-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N040024-001	DEXFERRUM	EQ 50MG IRON/ML	INJECTABLE / INJECTION	1996-02-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N040024-001	DEXFERRUM	EQ 50MG IRON/ML	INJECTABLE / INJECTION	1996-02-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N040024-001	DEXFERRUM	EQ 50MG IRON/ML	INJECTABLE / INJECTION	1996-02-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N040024-001	DEXFERRUM	EQ 50MG IRON/ML	INJECTABLE / INJECTION	1996-02-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N040024-001	DEXFERRUM	EQ 50MG IRON/ML	INJECTABLE / INJECTION	1996-02-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N040024-001	DEXFERRUM	EQ 50MG IRON/ML	INJECTABLE / INJECTION	1996-02-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N040024-001	DEXFERRUM	EQ 50MG IRON/ML	INJECTABLE / INJECTION	1996-02-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N040024-001	DEXFERRUM	EQ 50MG IRON/ML	INJECTABLE / INJECTION	1996-02-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N040024-001	DEXFERRUM	EQ 50MG IRON/ML	INJECTABLE / INJECTION	1996-02-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N040024-001	DEXFERRUM	EQ 50MG IRON/ML	INJECTABLE / INJECTION	1996-02-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N040024-001	DEXFERRUM	EQ 50MG IRON/ML	INJECTABLE / INJECTION	1996-02-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N040024-001	DEXFERRUM	EQ 50MG IRON/ML	INJECTABLE / INJECTION	1996-02-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N040024-001	DEXFERRUM	EQ 50MG IRON/ML	INJECTABLE / INJECTION	1996-02-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N040024-001	DEXFERRUM	EQ 50MG IRON/ML	INJECTABLE / INJECTION	1996-02-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N040024-001	DEXFERRUM	EQ 50MG IRON/ML	INJECTABLE / INJECTION	1996-02-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N040024-001	DEXFERRUM	EQ 50MG IRON/ML	INJECTABLE / INJECTION	1996-02-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N040024-001	DEXFERRUM	EQ 50MG IRON/ML	INJECTABLE / INJECTION	1996-02-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N040024-001	DEXFERRUM	EQ 50MG IRON/ML	INJECTABLE / INJECTION	1996-02-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N040024-001	DEXFERRUM	EQ 50MG IRON/ML	INJECTABLE / INJECTION	1996-02-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N040024-001	DEXFERRUM	EQ 50MG IRON/ML	INJECTABLE / INJECTION	1996-02-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N040024-001	DEXFERRUM	EQ 50MG IRON/ML	INJECTABLE / INJECTION	1996-02-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N040024-001	DEXFERRUM	EQ 50MG IRON/ML	INJECTABLE / INJECTION	1996-02-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N040024-001	DEXFERRUM	EQ 50MG IRON/ML	INJECTABLE / INJECTION	1996-02-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N040024-001	DEXFERRUM	EQ 50MG IRON/ML	INJECTABLE / INJECTION	1996-02-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N040024-001	DEXFERRUM	EQ 50MG IRON/ML	INJECTABLE / INJECTION	1996-02-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N040024-001	DEXFERRUM	EQ 50MG IRON/ML	INJECTABLE / INJECTION	1996-02-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N040024-001	DEXFERRUM	EQ 50MG IRON/ML	INJECTABLE / INJECTION	1996-02-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N040024-001	DEXFERRUM	EQ 50MG IRON/ML	INJECTABLE / INJECTION	1996-02-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N040024-001	DEXFERRUM	EQ 50MG IRON/ML	INJECTABLE / INJECTION	1996-02-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N040024-001	DEXFERRUM	EQ 50MG IRON/ML	INJECTABLE / INJECTION	1996-02-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N040024-001	DEXFERRUM	EQ 50MG IRON/ML	INJECTABLE / INJECTION	1996-02-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N040024-001	DEXFERRUM	EQ 50MG IRON/ML	INJECTABLE / INJECTION	1996-02-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N040024-001	DEXFERRUM	EQ 50MG IRON/ML	INJECTABLE / INJECTION	1996-02-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N040024-001	DEXFERRUM	EQ 50MG IRON/ML	INJECTABLE / INJECTION	1996-02-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N040024-001	DEXFERRUM	EQ 50MG IRON/ML	INJECTABLE / INJECTION	1996-02-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N040024-001	DEXFERRUM	EQ 50MG IRON/ML	INJECTABLE / INJECTION	1996-02-23	`f41ea6bd6efb…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
INFED	IRON DEXTRAN	Henry Schein, Inc.	99bf34be-cb8a-46d1-9637-5544dc2da287	2026-04-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IRON DEXTRAN
IRON DEXTRAN	IRON DEXTRAN	HF Acquisition Co LLC, DBA HealthFirst	9a4cd424-865d-fdd1-e053-2995a90a00ff	2025-01-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IRON DEXTRAN
INFeD	IRON DEXTRAN	Allergan, Inc.	94b01b1e-794b-4bea-8e24-2e54683fc023	2024-08-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IRON DEXTRAN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
17746	SUPPL	2009-09-22