Application 017441

Type: NDA
Sponsor: ALLERGAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	INFED	IRON DEXTRAN	INJECTABLE;INJECTION	EQ 50MG IRON/ML	Yes	Yes

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
N017441-001	INFED	IRON DEXTRAN	EQ 100MG IRON/2ML (EQ 50MG IRON/ML)	INJECTABLE / INJECTION	BP	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N017441-001	BP

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 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2022-09-29 23:25 UTC	2022-09	N017441-001	INFED	EQ 100MG IRON/2ML (EQ 50MG IRON/ML)	INJECTABLE / INJECTION	BP	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017441-001	INFED	EQ 100MG IRON/2ML (EQ 50MG IRON/ML)	INJECTABLE / INJECTION	BP	RLD, RS, Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N017441-001	INFED	EQ 100MG IRON/2ML (EQ 50MG IRON/ML)	INJECTABLE / INJECTION	BP	RLD, RS, Approved before 1982	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N017441-001	BP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N017441-001	BP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017441-001	BP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017441-001	BP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017441-001	BP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017441-001	BP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017441-001	BP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017441-001	BP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017441-001	BP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017441-001	BP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017441-001	BP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017441-001	BP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017441-001	BP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017441-001	BP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017441-001	BP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017441-001	BP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017441-001	BP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017441-001	BP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017441-001	BP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017441-001	BP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017441-001	BP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017441-001	BP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017441-001	BP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017441-001	BP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017441-001	BP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017441-001	BP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017441-001	BP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017441-001	BP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017441-001	BP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017441-001	BP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017441-001	BP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017441-001	BP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017441-001	BP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017441-001	BP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017441-001	BP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017441-001	BP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017441-001	BP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017441-001	BP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017441-001	BP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N017441-001	BP	1	`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	Exact identifier application applno (NDA): 017441 application number: NDA017441 ndc (product): 0404-9879
IRON DEXTRAN	IRON DEXTRAN	HF Acquisition Co LLC, DBA HealthFirst	9a4cd424-865d-fdd1-e053-2995a90a00ff	2025-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 017441 application number: NDA017441 ndc (product): 51662-1441
INFeD	IRON DEXTRAN	Allergan, Inc.	94b01b1e-794b-4bea-8e24-2e54683fc023	2024-08-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 017441 application number: NDA017441 ndc (product): 0023-6082

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 · 23 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0023-6082	INFeD	Iron Dextran	Allergan, Inc.	NDA	Current
0023-6082	INFeD	Iron Dextran	Allergan, Inc.	NDA	Current
0023-6082	INFeD	Iron Dextran	Allergan, Inc.	NDA	Current
0023-6082	INFeD	Iron Dextran	Allergan, Inc.	NDA	Current
0023-6082	INFeD	Iron Dextran	Allergan, Inc.	NDA	Current
0023-6082	INFeD	Iron Dextran	Allergan, Inc.	NDA	Current
0023-6082	INFeD	Iron Dextran	Allergan, Inc.	NDA	Current
0023-6082	INFeD	Iron Dextran	Allergan, Inc.	NDA	Current
0404-9879	INFED	iron dextran	Henry Schein, Inc.	NDA	Current
0404-9879	INFED	iron dextran	Henry Schein, Inc.	NDA	Current
0404-9879	INFED	iron dextran	Henry Schein, Inc.	NDA	Current
51662-1441	IRON DEXTRAN	IRON DEXTRAN	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1441	IRON DEXTRAN	IRON DEXTRAN	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
52544-931	INFeD	Iron Dextran	Actavis Pharma, Inc.	NDA	Current
52544-931	INFeD	Iron Dextran	Actavis Pharma, Inc.	NDA	Current
52584-086	INFED	iron dextran	General Injectables & Vaccines, Inc.	NDA	Current
52584-086	INFED	iron dextran	General Injectables & Vaccines, Inc.	NDA	Current
52584-086	INFED	iron dextran	General Injectables & Vaccines, Inc.	NDA	Current
52584-086	INFED	iron dextran	General Injectables & Vaccines, Inc.	NDA	Current
52584-086	INFED	iron dextran	General Injectables & Vaccines, Inc.	NDA	Current
52584-931	Infed	Iron Dextran	General Injectables & Vaccines, Inc	NDA	Current
52584-931	Infed	Iron Dextran	General Injectables & Vaccines, Inc	NDA	Current
52584-931	Infed	Iron Dextran	General Injectables & Vaccines, Inc	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
79297	SUPPL	2024-08-02
79287	SUPPL	2024-08-02
68627	SUPPL	2021-09-15
67152	SUPPL	2021-04-22
67131	SUPPL	2021-04-22
64617	SUPPL	2020-09-21
64566	SUPPL	2020-09-14
33268	SUPPL	2009-09-17
13136	SUPPL	2001-04-18