Application 207759

Type: ANDA
Sponsor: ZYDUS PHARMS

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
A207759-001	SEVELAMER CARBONATE	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB		2020-08-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207759-001	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.

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	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A207759-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2020-08-11	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A207759-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207759-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207759-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207759-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207759-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207759-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207759-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207759-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207759-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207759-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207759-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207759-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207759-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207759-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207759-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207759-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207759-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207759-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A207759-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207759-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207759-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207759-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207759-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207759-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207759-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207759-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207759-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207759-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207759-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207759-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207759-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207759-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207759-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207759-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207759-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207759-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207759-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A207759-001	AB	1	`a50c72e98297…`

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
Sevelamer carbonate	SEVELAMER CARBONATE	Zydus Lifesciences Limited	cbdee883-ccc7-4c55-965d-b608a214b375	2024-08-12		Exact identifier application applno (ANDA): 207759 application number: ANDA207759 ndc (product): 70771-1520
Sevelamer carbonate	SEVELAMER CARBONATE	Zydus Pharmaceuticals USA Inc.	71f61492-8971-424a-8415-dfd2e15d05d9	2023-11-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207759 application number: ANDA207759 ndc (product): 68382-824

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
68382-824	Sevelamer carbonate	Sevelamer carbonate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-824	Sevelamer carbonate	Sevelamer carbonate	Zydus Pharmaceuticals USA Inc.	ANDA	Current
70771-1520	Sevelamer carbonate	Sevelamer carbonate	Zydus Lifesciences Limited	ANDA	Current
70771-1520	Sevelamer carbonate	Sevelamer carbonate	Cadila Healthcare Limited	ANDA	Current