Application 090975

Type: ANDA
Sponsor: IMPAX LABS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SEVELAMER CARBONATE	SEVELAMER CARBONATE	TABLET;ORAL	800MG	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
A090975-001	SEVELAMER CARBONATE	SEVELAMER CARBONATE	800MG	TABLET / ORAL			2017-10-23

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090975-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL		2017-10-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090975-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL		2017-10-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090975-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL		2017-10-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090975-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL		2017-10-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090975-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL		2017-10-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090975-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL		2017-10-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090975-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL		2017-10-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090975-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL		2017-10-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090975-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL		2017-10-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090975-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL		2017-10-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090975-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL		2017-10-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090975-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL		2017-10-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090975-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL		2017-10-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090975-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL		2017-10-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090975-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL		2017-10-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090975-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL		2017-10-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090975-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL		2017-10-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090975-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090975-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL		2017-10-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090975-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL		2017-10-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090975-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL		2017-10-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090975-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL		2017-10-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090975-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL		2017-10-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090975-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL		2017-10-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090975-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090975-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090975-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090975-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL		2017-10-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090975-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL		2017-10-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090975-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL		2017-10-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090975-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL		2017-10-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090975-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL		2017-10-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090975-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL		2017-10-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090975-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL		2017-10-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090975-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL		2017-10-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090975-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL		2017-10-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090975-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL		2017-10-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090975-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL		2017-10-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090975-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL		2017-10-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090975-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL		2017-10-23	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A090975-001	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A090975-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090975-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090975-001	AB	1	`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 3 · 42 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SEVELAMER CARBONATE	SEVELAMER CARBONATE	NorthStar RxLLC	5baf3742-5929-42f8-8865-6b3e92647d5b	2026-07-16	Warnings, Adverse reactions	Name fallback brand name: SEVELAMER CARBONATE generic name: SEVELAMER CARBONATE
Sevelamer Carbonate	SEVELAMER CARBONATE	Macleods Pharmaceuticals Limited	4c927d50-34a6-499b-b1c2-924d4eb73987	2026-07-10	Warnings, Adverse reactions	Name fallback brand name: Sevelamer Carbonate generic name: SEVELAMER CARBONATE
Sevelamer Carbonate	SEVELAMER CARBONATE	Marp Pharma	515ae758-ccba-5758-e063-6394a90a315b	2026-06-17	Warnings, Adverse reactions	Name fallback brand name: Sevelamer Carbonate generic name: SEVELAMER CARBONATE
SEVELAMER CARBONATE	SEVELAMER CARBONATE	INSIGNAMEDEX LLC	51ce2ed6-3acf-a6ea-e063-6294a90a21aa	2026-05-22	Warnings, Adverse reactions	Name fallback brand name: SEVELAMER CARBONATE generic name: SEVELAMER CARBONATE
REVENLA	SEVELAMER CARBONATE	INSIGNAMEDEX LLC	5167a163-c142-b73b-e063-6294a90abd49	2026-05-09		Name fallback generic name: SEVELAMER CARBONATE
SEVELAMER CARBONATE	SEVELAMER CARBONATE	PD-Rx Pharmaceuticals, Inc.	b72baeeb-b6f5-4fa1-bee8-9eb4bb74dc82	2026-04-17	Warnings, Adverse reactions	Name fallback brand name: SEVELAMER CARBONATE generic name: SEVELAMER CARBONATE
Sevelamer carbonate	SEVELAMER CARBONATE	Zydus Pharmaceuticals USA Inc.	2ccf62c6-dbad-416d-8e02-631795bd7517	2026-03-18	Warnings, Adverse reactions	Name fallback brand name: Sevelamer carbonate generic name: SEVELAMER CARBONATE
Sevelamer Carbonate	SEVELAMER CARBONATE	AvPAK	7f701cb4-3089-375f-e053-2991aa0a51b9	2026-01-20	Warnings, Adverse reactions	Name fallback brand name: Sevelamer Carbonate generic name: SEVELAMER CARBONATE
Sevelamer carbonate	SEVELAMER CARBONATE	Navinta LLC	d2f0c283-3e9d-41db-bd4d-83bd21f2a019	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Sevelamer carbonate generic name: SEVELAMER CARBONATE
Sevelamer Carbonate	SEVELAMER CARBONATE	Cardinal Health 107, LLC	65184825-adce-480e-a4c3-b21e37656cf4	2025-12-19	Warnings, Adverse reactions	Name fallback brand name: Sevelamer Carbonate generic name: SEVELAMER CARBONATE
SEVELAMER CARBONATE	SEVELAMER CARBONATE	Shandong Xinhua Pharmaceutical Co., Ltd.	f6455fa3-ad53-f6fd-e053-2a95a90a67db	2025-12-15	Warnings, Adverse reactions	Name fallback brand name: SEVELAMER CARBONATE generic name: SEVELAMER CARBONATE
SEVELAMER CARBONATE	SEVELAMER CARBONATE	AiPing Pharmaceutical, Inc.	0cade89a-38ca-4072-97a0-be09c6e058f4	2025-12-04	Warnings, Adverse reactions	Name fallback brand name: SEVELAMER CARBONATE generic name: SEVELAMER CARBONATE
Sevelamer Carbonate	SEVELAMER CARBONATE	Sanofi-Aventis U.S. LLC	3abc32fe-1bfc-4759-8f7c-36095e221b06	2025-11-25	Warnings, Adverse reactions	Name fallback brand name: Sevelamer Carbonate generic name: SEVELAMER CARBONATE
Renvela	SEVELAMER CARBONATE	Genzyme Corporation	e6328460-a57b-450b-a48c-6dcd4b476360	2025-11-25	Warnings, Adverse reactions	Name fallback generic name: SEVELAMER CARBONATE
Sevelamer Carbonate	SEVELAMER CARBONATE	Bryant Ranch Prepack	462a11b9-78a3-4d8b-ae5d-3d6528e4d743	2025-11-21	Warnings, Adverse reactions	Name fallback brand name: Sevelamer Carbonate generic name: SEVELAMER CARBONATE
Sevelamer Carbonate	SEVELAMER CARBONATE	Major Pharmaceuticals	42fefb90-6941-4539-8f32-df1896223450	2025-11-13	Warnings, Adverse reactions	Name fallback brand name: Sevelamer Carbonate generic name: SEVELAMER CARBONATE
Sevelamer Carbonate	SEVELAMER CARBONATE	AvKARE	41890246-efa5-524a-e063-6294a90a5ad9	2025-10-19	Warnings, Adverse reactions	Name fallback brand name: Sevelamer Carbonate generic name: SEVELAMER CARBONATE
Sevelamer Carbonate	SEVELAMER CARBONATE	Westminster Pharmaceuticals, LLC	45a955e9-94ac-48db-838c-74934eae245b	2025-10-01	Warnings, Adverse reactions	Name fallback brand name: Sevelamer Carbonate generic name: SEVELAMER CARBONATE
SEVELAMER CARBONATE	SEVELAMER CARBONATE	Macleods Pharmaceuticals Limited	48dbd7a7-32c7-45c1-ac8b-c478cf3282a6	2025-09-26	Warnings, Adverse reactions	Name fallback brand name: SEVELAMER CARBONATE generic name: SEVELAMER CARBONATE
Sevelamer Carbonate	SEVELAMER CARBONATE	Precision Dose, Inc.	09b5e422-18c9-49dc-be3d-5d24648184af	2025-08-11	Warnings, Adverse reactions	Name fallback brand name: Sevelamer Carbonate generic name: SEVELAMER CARBONATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0115-1309	Sevelamer Carbonate	Sevelamer Carbonate	Impax Generics	ANDA	Current
0115-1309	Sevelamer Carbonate	Sevelamer Carbonate	Impax Generics	ANDA	Current
42291-763	Sevelamer Carbonate	Sevelamer Carbonate	AvKARE, Inc.	ANDA	Current
42291-763	Sevelamer Carbonate	Sevelamer Carbonate	AvKARE	ANDA	Current
70518-1102	Sevelamer Carbonate	Sevelamer Carbonate	REMEDYREPACK INC.	ANDA	Current
70518-1102	Sevelamer Carbonate	Sevelamer Carbonate	REMEDYREPACK INC.	ANDA	Current