Application 212970

Type: ANDA
Sponsor: ANXIN

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 42.

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
A212970-001	SEVELAMER CARBONATE	SEVELAMER CARBONATE	800MG	TABLET / ORAL			2020-04-09

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A212970-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL		2020-04-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212970-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL		2020-04-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212970-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL		2020-04-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212970-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL		2020-04-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212970-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL		2020-04-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212970-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL		2020-04-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212970-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL		2020-04-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212970-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL		2020-04-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212970-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL		2020-04-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212970-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL		2020-04-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212970-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL		2020-04-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212970-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL		2020-04-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212970-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL		2020-04-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212970-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL		2020-04-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212970-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL		2020-04-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212970-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-04-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212970-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-04-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212970-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-04-09	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212970-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-04-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212970-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-04-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212970-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-04-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212970-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL		2020-04-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212970-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL		2020-04-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212970-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL		2020-04-09	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212970-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-04-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212970-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-04-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212970-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-04-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212970-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-04-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212970-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-04-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212970-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-04-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212970-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-04-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212970-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-04-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212970-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-04-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212970-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-04-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212970-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-04-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212970-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-04-09	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212970-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-04-09	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212970-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL		2020-04-09	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212970-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212970-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212970-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212970-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212970-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212970-001	AB	1	`87673890dc5c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212970-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212970-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212970-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212970-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212970-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212970-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212970-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212970-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212970-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212970-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212970-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212970-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212970-001	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sevelamer Carbonate	SEVELAMER CARBONATE	Marp Pharma	515ae758-ccba-5758-e063-6394a90a315b	2026-06-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212970 application number: ANDA212970
SEVELAMER CARBONATE	SEVELAMER CARBONATE	INSIGNAMEDEX LLC	51ce2ed6-3acf-a6ea-e063-6294a90a21aa	2026-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212970 application number: ANDA212970
REVENLA	SEVELAMER CARBONATE	INSIGNAMEDEX LLC	5167a163-c142-b73b-e063-6294a90abd49	2026-05-09		Exact identifier application applno (ANDA): 212970 application number: ANDA212970

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69680-143	SEVELAMER CARBONATE	SEVELAMER CARBONATE	Vitruvias Therapeutics	ANDA	Current
69680-143	SEVELAMER CARBONATE	SEVELAMER CARBONATE	Vitruvias Therapeutics	ANDA	Current
69680-143	SEVELAMER CARBONATE	SEVELAMER CARBONATE	Vitruvias Therapeutics	ANDA	Current
72915-301	SEVELAMER CARBONATE	SEVELAMER CARBONATE	Anxin Pharma Inc.	ANDA	Current