Application 203860

Type: ANDA
Sponsor: INVAGEN 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
A203860-001	SEVELAMER CARBONATE	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB		2017-10-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203860-001	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.

Product history page 1 of 2 · 42 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
2026-08-18 06:07:40	2026-07	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203860-001	SEVELAMER CARBONATE	800MG	TABLET / ORAL	AB	2017-10-26	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A203860-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203860-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203860-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203860-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203860-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203860-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203860-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203860-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203860-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203860-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203860-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203860-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203860-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203860-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203860-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203860-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203860-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203860-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203860-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203860-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203860-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203860-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203860-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203860-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203860-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203860-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203860-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203860-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203860-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203860-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203860-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203860-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203860-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203860-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203860-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203860-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203860-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203860-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203860-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203860-001	AB	1	`e64feba35796…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sevelamer carbonate	SEVELAMER CARBONATE	Cipla USA Inc.	134f32c1-b5d5-44d0-9da5-85033e99320a	2023-01-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203860 application number: ANDA203860 ndc (product): 69097-967
Sevelamer carbonate	SEVELAMER CARBONATE	Exelan Pharmaceuticals Inc.	f8947f65-57be-4af7-b0e7-17666f496d01	2020-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203860 application number: ANDA203860 ndc (product): 76282-664
Sevelamer carbonate	SEVELAMER CARBONATE	Cipla USA Inc.	f63450bd-d075-4810-a277-e8bc41e4a5af	2018-12-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203860 application number: ANDA203860 ndc (product): 69097-893
Sevelamer carbonate	SEVELAMER CARBONATE	Exelan Pharmaceuticals Inc.	568b8558-6117-4c2f-aabf-86e567b38863	2018-11-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203860 application number: ANDA203860 ndc (product): 76282-407

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50436-0893	Sevelamer carbonate	SEVELAMER CARBONATE	Unit Dose Services	ANDA	Current
67787-407	Sevelamer carbonate	SEVELAMER CARBONATE	InvaGen Pharmaceuticals Inc.	ANDA	Current
69097-893	Sevelamer carbonate	SEVELAMER CARBONATE	Cipla USA Inc.	ANDA	Current
69097-967	Sevelamer carbonate	SEVELAMER CARBONATE	Cipla USA Inc.	ANDA	Current
69097-967	Sevelamer carbonate	SEVELAMER CARBONATE	Cipla USA Inc.	ANDA	Current
69097-967	Sevelamer carbonate	SEVELAMER CARBONATE	Cipla USA Inc.	ANDA	Current
70518-0909	Sevelamer carbonate	SEVELAMER CARBONATE	REMEDYREPACK INC.	ANDA	Current
70518-0909	Sevelamer carbonate	SEVELAMER CARBONATE	REMEDYREPACK INC.	ANDA	Current
76282-407	Sevelamer carbonate	SEVELAMER CARBONATE	Exelan Pharmaceuticals Inc.	ANDA	Current
76282-664	Sevelamer carbonate	SEVELAMER CARBONATE	Exelan Pharmaceuticals Inc.	ANDA	Current
76282-664	Sevelamer carbonate	SEVELAMER CARBONATE	Exelan Pharmaceuticals Inc.	ANDA	Current