Application 021179

Type: NDA
Sponsor: GENZYME

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RENAGEL	SEVELAMER HYDROCHLORIDE	TABLET;ORAL	400MG	Yes	No
002	RENAGEL	SEVELAMER HYDROCHLORIDE	TABLET;ORAL	800MG	Yes	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021179-001	RENAGEL	SEVELAMER HYDROCHLORIDE	400MG	TABLET / ORAL	AB	RLD	2000-07-12
N021179-002	RENAGEL	SEVELAMER HYDROCHLORIDE	800MG	TABLET / ORAL	AB	RLD, RS	2000-07-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N021179-001	AB
N021179-002	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 3 · 82 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	N021179-001	RENAGEL	400MG	TABLET / ORAL	AB	RLD	2000-07-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021179-002	RENAGEL	800MG	TABLET / ORAL	AB	RLD, RS	2000-07-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021179-001	RENAGEL	400MG	TABLET / ORAL	AB	RLD	2000-07-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021179-002	RENAGEL	800MG	TABLET / ORAL	AB	RLD, RS	2000-07-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021179-001	RENAGEL	400MG	TABLET / ORAL	AB	RLD	2000-07-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021179-002	RENAGEL	800MG	TABLET / ORAL	AB	RLD, RS	2000-07-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021179-001	RENAGEL	400MG	TABLET / ORAL	AB	RLD	2000-07-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021179-002	RENAGEL	800MG	TABLET / ORAL	AB	RLD, RS	2000-07-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021179-001	RENAGEL	400MG	TABLET / ORAL	AB	RLD	2000-07-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021179-002	RENAGEL	800MG	TABLET / ORAL	AB	RLD, RS	2000-07-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021179-001	RENAGEL	400MG	TABLET / ORAL	AB	RLD	2000-07-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021179-002	RENAGEL	800MG	TABLET / ORAL	AB	RLD, RS	2000-07-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021179-001	RENAGEL	400MG	TABLET / ORAL	AB	RLD	2000-07-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021179-002	RENAGEL	800MG	TABLET / ORAL	AB	RLD, RS	2000-07-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021179-001	RENAGEL	400MG	TABLET / ORAL	AB	RLD	2000-07-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021179-002	RENAGEL	800MG	TABLET / ORAL	AB	RLD, RS	2000-07-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021179-001	RENAGEL	400MG	TABLET / ORAL	AB	RLD	2000-07-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021179-002	RENAGEL	800MG	TABLET / ORAL	AB	RLD, RS	2000-07-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021179-001	RENAGEL	400MG	TABLET / ORAL	AB	RLD	2000-07-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021179-002	RENAGEL	800MG	TABLET / ORAL	AB	RLD, RS	2000-07-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021179-001	RENAGEL	400MG	TABLET / ORAL	AB	RLD	2000-07-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021179-002	RENAGEL	800MG	TABLET / ORAL	AB	RLD, RS	2000-07-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021179-001	RENAGEL	400MG	TABLET / ORAL	AB	RLD	2000-07-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021179-002	RENAGEL	800MG	TABLET / ORAL	AB	RLD, RS	2000-07-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021179-001	RENAGEL	400MG	TABLET / ORAL	AB	RLD	2000-07-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021179-002	RENAGEL	800MG	TABLET / ORAL	AB	RLD, RS	2000-07-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021179-001	RENAGEL	400MG	TABLET / ORAL	AB	RLD	2000-07-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021179-002	RENAGEL	800MG	TABLET / ORAL	AB	RLD, RS	2000-07-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021179-001	RENAGEL	400MG	TABLET / ORAL	AB	RLD	2000-07-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021179-002	RENAGEL	800MG	TABLET / ORAL	AB	RLD, RS	2000-07-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021179-001	RENAGEL	400MG	TABLET / ORAL	AB	RLD	2000-07-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021179-002	RENAGEL	800MG	TABLET / ORAL	AB	RLD, RS	2000-07-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021179-001	RENAGEL	400MG	TABLET / ORAL	AB	RLD	2000-07-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021179-002	RENAGEL	800MG	TABLET / ORAL	AB	RLD, RS	2000-07-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021179-001	RENAGEL	400MG	TABLET / ORAL	AB	RLD	2000-07-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021179-002	RENAGEL	800MG	TABLET / ORAL	AB	RLD, RS	2000-07-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021179-001	RENAGEL	400MG	TABLET / ORAL	AB	RLD	2000-07-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021179-002	RENAGEL	800MG	TABLET / ORAL	AB	RLD, RS	2000-07-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021179-001	RENAGEL	400MG	TABLET / ORAL	AB	RLD	2000-07-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021179-002	RENAGEL	800MG	TABLET / ORAL	AB	RLD, RS	2000-07-12	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	N021179-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021179-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021179-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021179-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021179-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021179-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021179-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021179-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021179-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021179-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021179-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021179-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021179-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021179-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021179-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021179-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021179-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021179-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021179-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021179-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021179-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021179-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021179-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021179-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021179-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021179-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021179-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021179-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021179-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021179-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021179-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021179-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021179-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021179-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021179-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021179-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021179-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021179-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021179-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021179-002	AB	1	`782e0a99824c…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021179-001	6733780	2020-10-18	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021179-002	6733780	2020-10-18	Drug product	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N021179-001	6733780	2020-10-18	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021179-002	6733780	2020-10-18	Drug product	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021179-001	6733780	2020-10-18	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021179-002	6733780	2020-10-18	Drug product	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021179-001	6733780	2020-10-18	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021179-002	6733780	2020-10-18	Drug product	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021179-001	6733780	2020-10-18	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021179-002	6733780	2020-10-18	Drug product	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021179-001	6733780	2020-10-18	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021179-002	6733780	2020-10-18	Drug product	`ea99ee380514…`

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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sevelamer Hydrochloride	SEVELAMER HYDROCHLORIDE	American Health Packaging	8830526f-d957-423e-84ea-e4d79346948b	2026-06-25	Warnings, Adverse reactions	Name fallback generic name: SEVELAMER HYDROCHLORIDE
sevelamer hydrochloride	SEVELAMER HYDROCHLORIDE	Cardinal Health 107, LLC	c13532a7-4c56-4084-839d-3dcfd4dc30f8	2026-02-26	Warnings, Adverse reactions	Name fallback generic name: SEVELAMER HYDROCHLORIDE
sevelamer hydrochloride	SEVELAMER HYDROCHLORIDE	Major Pharmaceuticals	0500034d-458c-42c5-918d-9acd22f0c28b	2026-02-13	Warnings, Adverse reactions	Name fallback generic name: SEVELAMER HYDROCHLORIDE
sevelamer hydrochloride	SEVELAMER HYDROCHLORIDE	Glenmark Pharmaceuticals Inc., USA	2cd6512f-0edd-4a30-a4fa-aa996038633c	2026-01-27	Warnings, Adverse reactions	Name fallback generic name: SEVELAMER HYDROCHLORIDE
sevelamer hydrochloride	SEVELAMER HYDROCHLORIDE	NorthStar RxLLC	a229a42a-4d1b-45df-aa77-71f44e0921ee	2025-08-15	Warnings, Adverse reactions	Name fallback generic name: SEVELAMER HYDROCHLORIDE
Sevelamer hydrochloride	SEVELAMER HYDROCHLORIDE	Lupin Pharmaceuticals, Inc.	a56c857e-bc39-484c-908d-f5957857efbb	2025-07-22	Warnings, Adverse reactions	Name fallback generic name: SEVELAMER HYDROCHLORIDE
Sevelamer Hydrochloride	SEVELAMER HYDROCHLORIDE	Bryant Ranch Prepack	35337152-9b92-40c0-e063-6294a90a8dd5	2025-05-15	Warnings, Adverse reactions	Name fallback generic name: SEVELAMER HYDROCHLORIDE
Sevelamer Hydrochloride	SEVELAMER HYDROCHLORIDE	Bryant Ranch Prepack	3533d24b-508e-f012-e063-6394a90acaf5	2025-05-15	Warnings, Adverse reactions	Name fallback generic name: SEVELAMER HYDROCHLORIDE
Sevelamer Hydrochloride	SEVELAMER HYDROCHLORIDE	Zydus Pharmaceuticals USA Inc.	ddecb552-5882-4e44-8fa7-37c9234dd1b9	2025-02-05	Warnings, Adverse reactions	Name fallback generic name: SEVELAMER HYDROCHLORIDE
SEVELAMER HYDROCHLORIDE	SEVELAMER HYDROCHLORIDE	Aurobindo Pharma Limited	d8729e42-dbbd-4954-9ce0-298743a15a06	2024-01-24	Warnings, Adverse reactions	Name fallback generic name: SEVELAMER HYDROCHLORIDE
Sevelamer Hydrochloride	SEVELAMER HYDROCHLORIDE	Macleods Pharmaceuticals Limited	6926ebbe-2d74-4d5f-b642-c1bfe3a4e305	2023-06-05	Warnings, Adverse reactions	Name fallback generic name: SEVELAMER HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0955-1048	Sevelamer Hydrochloride	Sevelamer Hydrochloride	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1048	Sevelamer Hydrochloride	Sevelamer Hydrochloride	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1048	Sevelamer Hydrochloride	Sevelamer Hydrochloride	Winthrop U.S, a business of sanofi-aventis U.S. LLC	NDA AUTHORIZED GENERIC	Current
0955-1048	Sevelamer Hydrochloride	Sevelamer Hydrochloride	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1048	Sevelamer Hydrochloride	Sevelamer Hydrochloride	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
0955-1048	Sevelamer Hydrochloride	Sevelamer Hydrochloride	Winthrop U.S.	NDA AUTHORIZED GENERIC	Current
17856-0021	Renagel	Renagel	Atlantic Biologicals Corps	NDA	Current
53808-0777	Renagel	Renagel	DOH CENTRAL PHARMACY	NDA	Current
58468-0020	Renagel	Renagel	Genzyme Corporation	NDA	Current
58468-0021	Renagel	sevelamer hydrochloride	Genzyme Corporation	NDA	Current
58468-0021	Renagel	Renagel	Genzyme Corporation	NDA	Current
58468-0021	Renagel	sevelamer hydrochloride	Genzyme Corporation	NDA	Current
58468-0021	Renagel	Renagel	Genzyme Corporation	NDA	Current
58468-0021	Renagel	Renagel	Genzyme Corporation	NDA	Current
67544-656	Renagel	Renagel	Aphena Pharma Solutions - Tennessee, LLC	NDA	Current
68151-4295	RENAGEL	Renagel	Carilion Materials Management	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
78035	SUPPL	2024-04-02
78031	SUPPL	2024-04-02
62804	SUPPL	2020-05-04
62788	SUPPL	2020-05-01
57785	SUPPL	2019-02-22
57766	SUPPL	2019-02-22
14586	SUPPL	2016-03-14
4572	SUPPL	2016-03-11
36297	SUPPL	2014-12-19
4571	SUPPL	2014-11-28
4570	SUPPL	2011-06-24
36296	SUPPL	2011-06-16
27004	SUPPL	2007-10-22
14584	SUPPL	2007-10-22
14585	SUPPL	2007-08-17
4569	SUPPL	2007-08-17
27003	SUPPL	2005-07-26
42003	ORIG	2004-03-11
27002	SUPPL	2004-03-03
27001	ORIG	2000-07-12
14583	ORIG	2000-07-12