Application 020926

Type: NDA
Sponsor: GENZYME

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RENAGEL	SEVELAMER HYDROCHLORIDE	CAPSULE;ORAL	403MG	No	No

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
N020926-001	RENAGEL	SEVELAMER HYDROCHLORIDE	403MG	CAPSULE / ORAL			1998-10-30

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020926-001	RENAGEL	403MG	CAPSULE / ORAL	1998-10-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020926-001	RENAGEL	403MG	CAPSULE / ORAL	1998-10-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020926-001	RENAGEL	403MG	CAPSULE / ORAL	1998-10-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020926-001	RENAGEL	403MG	CAPSULE / ORAL	1998-10-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020926-001	RENAGEL	403MG	CAPSULE / ORAL	1998-10-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020926-001	RENAGEL	403MG	CAPSULE / ORAL	1998-10-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020926-001	RENAGEL	403MG	CAPSULE / ORAL	1998-10-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020926-001	RENAGEL	403MG	CAPSULE / ORAL	1998-10-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020926-001	RENAGEL	403MG	CAPSULE / ORAL	1998-10-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020926-001	RENAGEL	403MG	CAPSULE / ORAL	1998-10-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020926-001	RENAGEL	403MG	CAPSULE / ORAL	1998-10-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020926-001	RENAGEL	403MG	CAPSULE / ORAL	1998-10-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020926-001	RENAGEL	403MG	CAPSULE / ORAL	1998-10-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020926-001	RENAGEL	403MG	CAPSULE / ORAL	1998-10-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020926-001	RENAGEL	403MG	CAPSULE / ORAL	1998-10-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020926-001	RENAGEL	403MG	CAPSULE / ORAL	1998-10-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020926-001	RENAGEL	403MG	CAPSULE / ORAL	1998-10-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020926-001	RENAGEL	403MG	CAPSULE / ORAL	1998-10-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020926-001	RENAGEL	403MG	CAPSULE / ORAL	1998-10-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020926-001	RENAGEL	403MG	CAPSULE / ORAL	1998-10-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020926-001	RENAGEL	403MG	CAPSULE / ORAL	1998-10-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020926-001	RENAGEL	403MG	CAPSULE / ORAL	1998-10-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020926-001	RENAGEL	403MG	CAPSULE / ORAL	1998-10-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020926-001	RENAGEL	403MG	CAPSULE / ORAL	1998-10-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020926-001	RENAGEL	403MG	CAPSULE / ORAL	1998-10-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020926-001	RENAGEL	403MG	CAPSULE / ORAL	1998-10-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020926-001	RENAGEL	403MG	CAPSULE / ORAL	1998-10-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020926-001	RENAGEL	403MG	CAPSULE / ORAL	1998-10-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020926-001	RENAGEL	403MG	CAPSULE / ORAL	1998-10-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020926-001	RENAGEL	403MG	CAPSULE / ORAL	1998-10-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020926-001	RENAGEL	403MG	CAPSULE / ORAL	1998-10-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020926-001	RENAGEL	403MG	CAPSULE / ORAL	1998-10-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020926-001	RENAGEL	403MG	CAPSULE / ORAL	1998-10-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020926-001	RENAGEL	403MG	CAPSULE / ORAL	1998-10-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020926-001	RENAGEL	403MG	CAPSULE / ORAL	1998-10-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020926-001	RENAGEL	403MG	CAPSULE / ORAL	1998-10-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020926-001	RENAGEL	403MG	CAPSULE / ORAL	1998-10-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020926-001	RENAGEL	403MG	CAPSULE / ORAL	1998-10-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020926-001	RENAGEL	403MG	CAPSULE / ORAL	1998-10-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020926-001	RENAGEL	403MG	CAPSULE / ORAL	1998-10-30	`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 · 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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
26209	SUPPL	2004-03-03
26208	SUPPL	2000-05-05
21278	ORIG	1999-07-04
26207	ORIG	1998-10-30
13749	ORIG	1998-10-30