Application 021135

Type: NDA
Sponsor: AM REGENT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VENOFER	IRON SUCROSE	INJECTABLE;INTRAVENOUS	EQ 100MG BASE/5ML (EQ 20MG BASE/ML)	Yes	Yes
002	VENOFER	IRON SUCROSE	INJECTABLE;INTRAVENOUS	EQ 50MG BASE/2.5ML (EQ 20MG BASE/ML)	Yes	No
003	VENOFER	IRON SUCROSE	INJECTABLE;INTRAVENOUS	EQ 75MG BASE/3.75ML (EQ 20MG BASE/ML)	No	No
004	VENOFER	IRON SUCROSE	INJECTABLE;INTRAVENOUS	EQ 200MG BASE/10ML (EQ 20MG BASE/ML)	Yes	No
005	VENOFER	IRON SUCROSE	INJECTABLE;INTRAVENOUS	EQ 65MG BASE/3.25ML (EQ 20MG BASE/ML)	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021135-001	VENOFER	IRON SUCROSE	EQ 100MG IRON/5ML (EQ 20MG IRON/ML)	INJECTABLE / INTRAVENOUS	AB	RLD, RS	2000-11-06
N021135-002	VENOFER	IRON SUCROSE	EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML)	INJECTABLE / INTRAVENOUS	AB	RLD	2005-03-20
N021135-003	VENOFER	IRON SUCROSE	EQ 75MG IRON/3.75ML (EQ 20MG IRON/ML)	INJECTABLE / INTRAVENOUS			2005-03-29
N021135-004	VENOFER	IRON SUCROSE	EQ 200MG IRON/10ML (EQ 20MG IRON/ML)	INJECTABLE / INTRAVENOUS	AB	RLD	2007-02-09
N021135-005	VENOFER	IRON SUCROSE	EQ 65MG IRON/3.25ML (EQ 20MG IRON/ML)	INJECTABLE / INTRAVENOUS			2013-03-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021135-001	AB
N021135-002	AB
N021135-004	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 6 · 210 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	N021135-001	VENOFER	EQ 100MG IRON/5ML (EQ 20MG IRON/ML)	INJECTABLE / INTRAVENOUS	AB	RLD, RS	2000-11-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021135-002	VENOFER	EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML)	INJECTABLE / INTRAVENOUS	AB	RLD	2005-03-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021135-003	VENOFER	EQ 75MG IRON/3.75ML (EQ 20MG IRON/ML)	INJECTABLE / INTRAVENOUS			2005-03-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021135-004	VENOFER	EQ 200MG IRON/10ML (EQ 20MG IRON/ML)	INJECTABLE / INTRAVENOUS	AB	RLD	2007-02-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021135-005	VENOFER	EQ 65MG IRON/3.25ML (EQ 20MG IRON/ML)	INJECTABLE / INTRAVENOUS			2013-03-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021135-001	VENOFER	EQ 100MG IRON/5ML (EQ 20MG IRON/ML)	INJECTABLE / INTRAVENOUS	AB	RLD, RS	2000-11-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021135-002	VENOFER	EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML)	INJECTABLE / INTRAVENOUS	AB	RLD	2005-03-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021135-003	VENOFER	EQ 75MG IRON/3.75ML (EQ 20MG IRON/ML)	INJECTABLE / INTRAVENOUS			2005-03-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021135-004	VENOFER	EQ 200MG IRON/10ML (EQ 20MG IRON/ML)	INJECTABLE / INTRAVENOUS	AB	RLD	2007-02-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021135-005	VENOFER	EQ 65MG IRON/3.25ML (EQ 20MG IRON/ML)	INJECTABLE / INTRAVENOUS			2013-03-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021135-001	VENOFER	EQ 100MG IRON/5ML (EQ 20MG IRON/ML)	INJECTABLE / INTRAVENOUS	AB	RLD, RS	2000-11-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021135-002	VENOFER	EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML)	INJECTABLE / INTRAVENOUS	AB	RLD	2005-03-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021135-003	VENOFER	EQ 75MG IRON/3.75ML (EQ 20MG IRON/ML)	INJECTABLE / INTRAVENOUS			2005-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021135-004	VENOFER	EQ 200MG IRON/10ML (EQ 20MG IRON/ML)	INJECTABLE / INTRAVENOUS	AB	RLD	2007-02-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021135-005	VENOFER	EQ 65MG IRON/3.25ML (EQ 20MG IRON/ML)	INJECTABLE / INTRAVENOUS			2013-03-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021135-001	VENOFER	EQ 100MG IRON/5ML (EQ 20MG IRON/ML)	INJECTABLE / INTRAVENOUS		RLD, RS	2000-11-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021135-002	VENOFER	EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML)	INJECTABLE / INTRAVENOUS		RLD	2005-03-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021135-003	VENOFER	EQ 75MG IRON/3.75ML (EQ 20MG IRON/ML)	INJECTABLE / INTRAVENOUS			2005-03-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021135-004	VENOFER	EQ 200MG IRON/10ML (EQ 20MG IRON/ML)	INJECTABLE / INTRAVENOUS		RLD	2007-02-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021135-005	VENOFER	EQ 65MG IRON/3.25ML (EQ 20MG IRON/ML)	INJECTABLE / INTRAVENOUS			2013-03-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021135-001	VENOFER	EQ 100MG IRON/5ML (EQ 20MG IRON/ML)	INJECTABLE / INTRAVENOUS		RLD, RS	2000-11-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021135-002	VENOFER	EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML)	INJECTABLE / INTRAVENOUS		RLD	2005-03-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021135-003	VENOFER	EQ 75MG IRON/3.75ML (EQ 20MG IRON/ML)	INJECTABLE / INTRAVENOUS			2005-03-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021135-004	VENOFER	EQ 200MG IRON/10ML (EQ 20MG IRON/ML)	INJECTABLE / INTRAVENOUS		RLD	2007-02-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021135-005	VENOFER	EQ 65MG IRON/3.25ML (EQ 20MG IRON/ML)	INJECTABLE / INTRAVENOUS			2013-03-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021135-001	VENOFER	EQ 100MG IRON/5ML (EQ 20MG IRON/ML)	INJECTABLE / INTRAVENOUS		RLD, RS	2000-11-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021135-002	VENOFER	EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML)	INJECTABLE / INTRAVENOUS		RLD	2005-03-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021135-003	VENOFER	EQ 75MG IRON/3.75ML (EQ 20MG IRON/ML)	INJECTABLE / INTRAVENOUS			2005-03-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021135-004	VENOFER	EQ 200MG IRON/10ML (EQ 20MG IRON/ML)	INJECTABLE / INTRAVENOUS		RLD	2007-02-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021135-005	VENOFER	EQ 65MG IRON/3.25ML (EQ 20MG IRON/ML)	INJECTABLE / INTRAVENOUS			2013-03-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021135-001	VENOFER	EQ 100MG IRON/5ML (EQ 20MG IRON/ML)	INJECTABLE / INTRAVENOUS		RLD, RS	2000-11-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021135-002	VENOFER	EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML)	INJECTABLE / INTRAVENOUS		RLD	2005-03-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021135-003	VENOFER	EQ 75MG IRON/3.75ML (EQ 20MG IRON/ML)	INJECTABLE / INTRAVENOUS			2005-03-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021135-004	VENOFER	EQ 200MG IRON/10ML (EQ 20MG IRON/ML)	INJECTABLE / INTRAVENOUS		RLD	2007-02-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021135-005	VENOFER	EQ 65MG IRON/3.25ML (EQ 20MG IRON/ML)	INJECTABLE / INTRAVENOUS			2013-03-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021135-001	VENOFER	EQ 100MG IRON/5ML (EQ 20MG IRON/ML)	INJECTABLE / INTRAVENOUS		RLD, RS	2000-11-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021135-002	VENOFER	EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML)	INJECTABLE / INTRAVENOUS		RLD	2005-03-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021135-003	VENOFER	EQ 75MG IRON/3.75ML (EQ 20MG IRON/ML)	INJECTABLE / INTRAVENOUS			2005-03-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021135-004	VENOFER	EQ 200MG IRON/10ML (EQ 20MG IRON/ML)	INJECTABLE / INTRAVENOUS		RLD	2007-02-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021135-005	VENOFER	EQ 65MG IRON/3.25ML (EQ 20MG IRON/ML)	INJECTABLE / INTRAVENOUS			2013-03-29	`2680178bc6a6…`

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	N021135-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021135-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021135-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021135-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021135-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021135-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021135-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021135-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021135-004	AB	1	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021135-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021135-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021135-004	AB	1	`a50c72e98297…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Venofer	IRON SUCROSE	American Regent, Inc.	b998ef36-81fa-40a1-9cd1-6d6156f91564	2026-03-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021135 application number: NDA021135 ndc (product): 0517-2340
Venofer	IRON SUCROSE	American Regent, Inc.	626dc9e5-c6b4-4f9c-9bf4-774fd3ae619a	2026-03-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021135 application number: NDA021135 ndc (product): 0517-2340 ndc (product): 0517-2310 ndc (product): 0517-2325
VENOFER (IRON SUCROSE)	VENOFER (IRON SUCROSE)	HF Acquisition Co LLC, DBA HealthFirst	c59cb54c-bee5-96d6-e053-2995a90a767c	2024-04-19	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021135 application number: NDA021135 ndc (product): 51662-1568
Venofer	IRON SUCROSE	Fresenius Medical Care Holdings, Inc.	f1ab1a22-2b99-4d27-8b5a-9c3bcd5e3040	2022-06-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021135 application number: NDA021135 ndc (product): 49230-534 ndc (product): 49230-530

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 48 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0517-2310	Venofer	iron sucrose	American Regent, Inc.	NDA	Current
0517-2310	Venofer	iron sucrose	American Regent, Inc.	NDA	Current
0517-2310	Venofer	iron sucrose	American Regent, Inc.	NDA	Current
0517-2310	Venofer	iron sucrose	American Regent, Inc.	NDA	Current
0517-2310	Venofer	iron sucrose	American Regent, Inc.	NDA	Current
0517-2310	Venofer	iron sucrose	American Regent, Inc.	NDA	Current
0517-2310	Venofer	iron sucrose	American Regent, Inc.	NDA	Current
0517-2310	Venofer	iron sucrose	American Regent, Inc.	NDA	Current
0517-2325	Venofer	iron sucrose	American Regent, Inc.	NDA	Current
0517-2325	Venofer	iron sucrose	American Regent, Inc.	NDA	Current
0517-2325	Venofer	iron sucrose	American Regent, Inc.	NDA	Current
0517-2325	Venofer	iron sucrose	American Regent, Inc.	NDA	Current
0517-2325	Venofer	iron sucrose	American Regent, Inc.	NDA	Current
0517-2325	Venofer	iron sucrose	American Regent, Inc.	NDA	Current
0517-2325	Venofer	iron sucrose	American Regent, Inc.	NDA	Current
0517-2325	Venofer	iron sucrose	American Regent, Inc.	NDA	Current
0517-2340	Venofer	iron sucrose	American Regent, Inc.	NDA	Current
0517-2340	Venofer	iron sucrose	American Regent, Inc.	NDA	Current
0517-2340	Venofer	iron sucrose	American Regent, Inc.	NDA	Current
0517-2340	Venofer	iron sucrose	American Regent, Inc.	NDA	Current
0517-2340	Venofer	iron sucrose	American Regent, Inc.	NDA	Current
0517-2340	Venofer	iron sucrose	American Regent, Inc.	NDA	Current
0517-2340	Venofer	iron sucrose	American Regent, Inc.	NDA	Current
0517-2340	Venofer	iron sucrose	American Regent, Inc.	NDA	Current
0517-2340	Venofer	iron sucrose	American Regent, Inc.	NDA	Current
0517-2340	Venofer	iron sucrose	American Regent, Inc.	NDA	Current
0517-2340	Venofer	iron sucrose	American Regent, Inc.	NDA	Current
0517-2340	Venofer	iron sucrose	American Regent, Inc.	NDA	Current
0517-2340	Venofer	iron sucrose	American Regent, Inc.	NDA	Current
0517-2340	Venofer	iron sucrose	American Regent, Inc.	NDA	Current
0517-2340	Venofer	iron sucrose	American Regent, Inc.	NDA	Current
49230-530	Venofer	iron sucrose	Fresenius Medical Care Holdings, Inc.	NDA	Current
49230-530	Venofer	iron sucrose	Fresenius Medical Care Holdings, Inc.	NDA	Current
49230-530	Venofer	iron sucrose	Fresenius Medical Care Holdings, Inc.	NDA	Current
49230-530	Venofer	iron sucrose	Fresenius Medical Care Holdings, Inc.	NDA	Current
49230-530	Venofer	iron sucrose	Fresenius Medical Care Holdings, Inc.	NDA	Current
49230-530	Venofer	iron sucrose	Fresenius Medical Care Holdings, Inc.	NDA	Current
49230-530	Venofer	iron sucrose	Fresenius Medical Care Holdings, Inc.	NDA	Current
49230-534	Venofer	iron sucrose	Fresenius Medical Care Holdings, Inc.	NDA	Current
49230-534	Venofer	iron sucrose	Fresenius Medical Care Holdings, Inc.	NDA	Current
49230-534	Venofer	iron sucrose	Fresenius Medical Care Holdings, Inc.	NDA	Current
49230-534	Venofer	iron sucrose	Fresenius Medical Care Holdings, Inc.	NDA	Current
49230-534	Venofer	iron sucrose	Fresenius Medical Care Holdings, Inc.	NDA	Current
49230-534	Venofer	iron sucrose	Fresenius Medical Care Holdings, Inc.	NDA	Current
49230-534	Venofer	iron sucrose	Fresenius Medical Care Holdings, Inc.	NDA	Current
50090-4541	Venofer	iron sucrose	A-S Medication Solutions	NDA	Current
50090-4541	Venofer	iron sucrose	A-S Medication Solutions	NDA	Current
51662-1568	VENOFER (IRON SUCROSE)	VENOFER (IRON SUCROSE)	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85381	SUPPL	2026-03-16
85380	SUPPL	2026-03-16
79298	SUPPL	2024-08-02
79289	SUPPL	2024-08-02
66971	SUPPL	2021-04-01
65945	SUPPL	2021-01-21
64592	SUPPL	2020-09-17
64569	SUPPL	2020-09-14
56945	SUPPL	2018-12-21
56891	SUPPL	2018-12-20
50554	SUPPL	2017-12-01
50525	SUPPL	2017-11-29
14478	SUPPL	2013-04-01
14479	SUPPL	2012-09-25
26880	SUPPL	2012-09-24
14477	SUPPL	2011-06-29
26879	SUPPL	2011-06-28
41974	SUPPL	2008-07-30
26878	SUPPL	2008-01-09
36199	SUPPL	2007-12-14
14476	SUPPL	2007-02-21
36198	SUPPL	2005-10-19
4438	SUPPL	2005-10-19
26876	SUPPL	2005-06-21
14475	SUPPL	2005-06-21
26877	SUPPL	2005-03-31
36197	ORIG	2004-06-29
21469	ORIG	2004-06-29
26875	SUPPL	2003-07-24
14474	SUPPL	2003-06-08
4437	SUPPL	2003-06-08
4436	ORIG	2000-11-13
51212	SUPPL	1900-01-01
51211	SUPPL	1900-01-01
51210	SUPPL	1900-01-01