Application 020955

Type: NDA
Sponsor: SANOFI AVENTIS US

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FERRLECIT	SODIUM FERRIC GLUCONATE COMPLEX	INJECTABLE;INJECTION	62.5MG/5ML	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N020955-001	FERRLECIT	SODIUM FERRIC GLUCONATE COMPLEX	EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)	INJECTABLE / INJECTION	AB	RLD, RS	1999-02-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020955-001	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 2 · 41 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
2026-02-19 14:30 UTC	2026-02	N020955-001	FERRLECIT	EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)	INJECTABLE / INJECTION	AB	RLD, RS	1999-02-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020955-001	FERRLECIT	EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)	INJECTABLE / INJECTION	AB	RLD, RS	1999-02-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020955-001	FERRLECIT	EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)	INJECTABLE / INJECTION	AB	RLD, RS	1999-02-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020955-001	FERRLECIT	EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)	INJECTABLE / INJECTION	AB	RLD, RS	1999-02-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020955-001	FERRLECIT	EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)	INJECTABLE / INJECTION	AB	RLD, RS	1999-02-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020955-001	FERRLECIT	EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)	INJECTABLE / INJECTION	AB	RLD, RS	1999-02-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020955-001	FERRLECIT	EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)	INJECTABLE / INJECTION	AB	RLD, RS	1999-02-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020955-001	FERRLECIT	EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)	INJECTABLE / INJECTION	AB	RLD, RS	1999-02-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020955-001	FERRLECIT	EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)	INJECTABLE / INJECTION	AB	RLD, RS	1999-02-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020955-001	FERRLECIT	EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)	INJECTABLE / INJECTION	AB	RLD, RS	1999-02-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020955-001	FERRLECIT	EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)	INJECTABLE / INJECTION	AB	RLD, RS	1999-02-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020955-001	FERRLECIT	EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)	INJECTABLE / INJECTION	AB	RLD, RS	1999-02-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020955-001	FERRLECIT	EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)	INJECTABLE / INJECTION	AB	RLD, RS	1999-02-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020955-001	FERRLECIT	EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)	INJECTABLE / INJECTION	AB	RLD, RS	1999-02-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020955-001	FERRLECIT	EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)	INJECTABLE / INJECTION	AB	RLD, RS	1999-02-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020955-001	FERRLECIT	EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)	INJECTABLE / INJECTION	AB	RLD, RS	1999-02-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020955-001	FERRLECIT	EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)	INJECTABLE / INJECTION	AB	RLD, RS	1999-02-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020955-001	FERRLECIT	62.5MG/5ML	INJECTABLE / INJECTION	AB	RLD, RS	1999-02-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020955-001	FERRLECIT	EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)	INJECTABLE / INJECTION	AB	RLD, RS	1999-02-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020955-001	FERRLECIT	EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)	INJECTABLE / INJECTION	AB	RLD, RS	1999-02-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020955-001	FERRLECIT	62.5MG/5ML	INJECTABLE / INJECTION	AB	RLD, RS	1999-02-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020955-001	FERRLECIT	62.5MG/5ML	INJECTABLE / INJECTION	AB	RLD, RS	1999-02-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020955-001	FERRLECIT	62.5MG/5ML	INJECTABLE / INJECTION	AB	RLD, RS	1999-02-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020955-001	FERRLECIT	62.5MG/5ML	INJECTABLE / INJECTION	AB	RLD, RS	1999-02-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020955-001	FERRLECIT	62.5MG/5ML	INJECTABLE / INJECTION	AB	RLD, RS	1999-02-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020955-001	FERRLECIT	62.5MG/5ML	INJECTABLE / INJECTION	AB	RLD, RS	1999-02-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020955-001	FERRLECIT	62.5MG/5ML	INJECTABLE / INJECTION	AB	RLD, RS	1999-02-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020955-001	FERRLECIT	EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)	INJECTABLE / INJECTION	AB	RLD, RS	1999-02-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020955-001	FERRLECIT	EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)	INJECTABLE / INJECTION	AB	RLD, RS	1999-02-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020955-001	FERRLECIT	EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)	INJECTABLE / INJECTION	AB	RLD, RS	1999-02-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020955-001	FERRLECIT	EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)	INJECTABLE / INJECTION	AB	RLD, RS	1999-02-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020955-001	FERRLECIT	EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)	INJECTABLE / INJECTION	AB	RLD, RS	1999-02-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020955-001	FERRLECIT	EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)	INJECTABLE / INJECTION	AB	RLD, RS	1999-02-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020955-001	FERRLECIT	EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)	INJECTABLE / INJECTION	AB	RLD, RS	1999-02-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020955-001	FERRLECIT	EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)	INJECTABLE / INJECTION	AB	RLD, RS	1999-02-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020955-001	FERRLECIT	EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)	INJECTABLE / INJECTION	AB	RLD, RS	1999-02-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020955-001	FERRLECIT	EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)	INJECTABLE / INJECTION	AB	RLD, RS	1999-02-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020955-001	FERRLECIT	EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)	INJECTABLE / INJECTION	AB	RLD, RS	1999-02-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020955-001	FERRLECIT	EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)	INJECTABLE / INJECTION	AB	RLD, RS	1999-02-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020955-001	FERRLECIT	EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)	INJECTABLE / INJECTION	AB	RLD, RS	1999-02-18	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020955-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020955-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020955-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020955-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020955-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020955-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020955-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020955-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020955-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020955-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020955-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020955-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020955-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020955-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020955-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020955-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020955-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020955-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020955-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020955-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020955-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020955-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020955-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020955-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020955-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020955-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020955-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020955-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020955-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020955-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020955-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020955-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020955-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020955-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020955-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020955-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020955-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020955-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020955-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020955-001	AB	1	`cb3db0bc1861…`

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
Ferrlecit	SODIUM FERRIC GLUCONATE COMPLEX	sanofi-aventis U.S. LLC	1fe028ff-42ac-4329-b1a5-a9dadfcb79f6	2025-10-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020955 application number: NDA020955 ndc (product): 0024-2792
Ferrlecit	SODIUM FERRIC GLUCONATE COMPLEX	sanofi-aventis U.S. LLC	b25b34ab-9cf1-4a2b-bdf2-5eaf66625999	2025-10-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020955 application number: NDA020955 ndc (product): 0024-2794

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
0024-2792	Ferrlecit	sodium ferric gluconate complex	sanofi-aventis U.S. LLC	NDA	Current
0024-2792	Ferrlecit	sodium ferric gluconate complex	sanofi-aventis U.S. LLC	NDA	Current
0024-2792	Ferrlecit	sodium ferric gluconate complex	sanofi-aventis U.S. LLC	NDA	Current
0024-2792	Ferrlecit	sodium ferric gluconate complex	sanofi-aventis U.S. LLC	NDA	Current
0024-2792	Ferrlecit	sodium ferric gluconate complex	sanofi-aventis U.S. LLC	NDA	Current
0024-2792	Ferrlecit	sodium ferric gluconate complex	sanofi-aventis U.S. LLC	NDA	Current
0024-2792	Ferrlecit	sodium ferric gluconate complex	sanofi-aventis U.S. LLC	NDA	Current
0024-2792	Ferrlecit	sodium ferric gluconate complex	sanofi-aventis U.S. LLC	NDA	Current
0024-2792	Ferrlecit	sodium ferric gluconate complex	sanofi-aventis U.S. LLC	NDA	Current
0024-2794	Ferrlecit	sodium ferric gluconate complex	sanofi-aventis U.S. LLC	NDA	Current
0024-2794	Ferrlecit	sodium ferric gluconate complex	sanofi-aventis U.S. LLC	NDA	Current
0024-2794	Ferrlecit	sodium ferric gluconate complex	sanofi-aventis U.S. LLC	NDA	Current
0024-2794	Ferrlecit	sodium ferric gluconate complex	sanofi-aventis U.S. LLC	NDA	Current
0024-2794	Ferrlecit	sodium ferric gluconate complex	sanofi-aventis U.S. LLC	NDA	Current
0024-2794	Ferrlecit	sodium ferric gluconate complex	sanofi-aventis U.S. LLC	NDA	Current
0024-2794	Ferrlecit	sodium ferric gluconate complex	sanofi-aventis U.S. LLC	NDA	Current
0024-2794	Ferrlecit	sodium ferric gluconate complex	sanofi-aventis U.S. LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
70543	SUPPL	2022-03-17
70538	SUPPL	2022-03-17
65498	SUPPL	2020-12-04
65491	SUPPL	2020-12-03
62421	SUPPL	2020-04-02
62405	SUPPL	2020-04-01
35718	SUPPL	2011-08-26
35717	SUPPL	2011-08-26
26297	SUPPL	2011-08-26
26296	SUPPL	2011-08-26
41838	SUPPL	2007-04-30
21302	SUPPL	2007-04-30
26295	SUPPL	2006-10-05
13812	SUPPL	2006-10-05
35716	SUPPL	2004-08-25
3845	SUPPL	2004-08-25
3844	SUPPL	2003-07-23
35715	SUPPL	2003-04-25
26294	SUPPL	2002-06-07
41837	ORIG	1999-02-18
35714	ORIG	1999-02-18
26293	ORIG	1999-02-18
52206	SUPPL	1900-01-01
52205	SUPPL	1900-01-01
52204	SUPPL	1900-01-01
52203	SUPPL	1900-01-01