Application 204724

Type: ANDA
Sponsor: GLENMARK PHARMS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SEVELAMER HYDROCHLORIDE	SEVELAMER HYDROCHLORIDE	TABLET;ORAL	400MG	No	No
002	SEVELAMER HYDROCHLORIDE	SEVELAMER HYDROCHLORIDE	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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A204724-001	SEVELAMER HYDROCHLORIDE	SEVELAMER HYDROCHLORIDE	400MG	TABLET / ORAL	AB		2019-02-08
A204724-002	SEVELAMER HYDROCHLORIDE	SEVELAMER HYDROCHLORIDE	800MG	TABLET / ORAL	AB		2019-02-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A204724-001	AB
A204724-002	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 3 · 82 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	A204724-001	SEVELAMER HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2019-02-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204724-002	SEVELAMER HYDROCHLORIDE	800MG	TABLET / ORAL	AB	2019-02-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204724-001	SEVELAMER HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2019-02-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204724-002	SEVELAMER HYDROCHLORIDE	800MG	TABLET / ORAL	AB	2019-02-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204724-001	SEVELAMER HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2019-02-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204724-002	SEVELAMER HYDROCHLORIDE	800MG	TABLET / ORAL	AB	2019-02-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204724-001	SEVELAMER HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2019-02-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204724-002	SEVELAMER HYDROCHLORIDE	800MG	TABLET / ORAL	AB	2019-02-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204724-001	SEVELAMER HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2019-02-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204724-002	SEVELAMER HYDROCHLORIDE	800MG	TABLET / ORAL	AB	2019-02-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204724-001	SEVELAMER HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2019-02-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204724-002	SEVELAMER HYDROCHLORIDE	800MG	TABLET / ORAL	AB	2019-02-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204724-001	SEVELAMER HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2019-02-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204724-002	SEVELAMER HYDROCHLORIDE	800MG	TABLET / ORAL	AB	2019-02-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204724-001	SEVELAMER HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2019-02-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204724-002	SEVELAMER HYDROCHLORIDE	800MG	TABLET / ORAL	AB	2019-02-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204724-001	SEVELAMER HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2019-02-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204724-002	SEVELAMER HYDROCHLORIDE	800MG	TABLET / ORAL	AB	2019-02-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204724-001	SEVELAMER HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2019-02-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204724-002	SEVELAMER HYDROCHLORIDE	800MG	TABLET / ORAL	AB	2019-02-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204724-001	SEVELAMER HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2019-02-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204724-002	SEVELAMER HYDROCHLORIDE	800MG	TABLET / ORAL	AB	2019-02-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204724-001	SEVELAMER HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2019-02-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204724-002	SEVELAMER HYDROCHLORIDE	800MG	TABLET / ORAL	AB	2019-02-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204724-001	SEVELAMER HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2019-02-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204724-002	SEVELAMER HYDROCHLORIDE	800MG	TABLET / ORAL	AB	2019-02-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204724-001	SEVELAMER HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2019-02-08	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204724-002	SEVELAMER HYDROCHLORIDE	800MG	TABLET / ORAL	AB	2019-02-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204724-001	SEVELAMER HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2019-02-08	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204724-002	SEVELAMER HYDROCHLORIDE	800MG	TABLET / ORAL	AB	2019-02-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204724-001	SEVELAMER HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2019-02-08	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204724-002	SEVELAMER HYDROCHLORIDE	800MG	TABLET / ORAL	AB	2019-02-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204724-001	SEVELAMER HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2019-02-08	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204724-002	SEVELAMER HYDROCHLORIDE	800MG	TABLET / ORAL	AB	2019-02-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204724-001	SEVELAMER HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2019-02-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204724-002	SEVELAMER HYDROCHLORIDE	800MG	TABLET / ORAL	AB	2019-02-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204724-001	SEVELAMER HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2019-02-08	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204724-002	SEVELAMER HYDROCHLORIDE	800MG	TABLET / ORAL	AB	2019-02-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204724-001	SEVELAMER HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2019-02-08	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204724-002	SEVELAMER HYDROCHLORIDE	800MG	TABLET / ORAL	AB	2019-02-08	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204724-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204724-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204724-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204724-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204724-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204724-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204724-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204724-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204724-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204724-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204724-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204724-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204724-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204724-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204724-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204724-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204724-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204724-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204724-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204724-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204724-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204724-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204724-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204724-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204724-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204724-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204724-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204724-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204724-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204724-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204724-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204724-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204724-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204724-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204724-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204724-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204724-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204724-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204724-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204724-002	AB	1	`782e0a99824c…`

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 · 5 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	Exact identifier application applno (ANDA): 204724 application number: ANDA204724 ndc (product): 60687-449
sevelamer hydrochloride	SEVELAMER HYDROCHLORIDE	Cardinal Health 107, LLC	c13532a7-4c56-4084-839d-3dcfd4dc30f8	2026-02-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204724 application number: ANDA204724
sevelamer hydrochloride	SEVELAMER HYDROCHLORIDE	Major Pharmaceuticals	0500034d-458c-42c5-918d-9acd22f0c28b	2026-02-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204724 application number: ANDA204724
sevelamer hydrochloride	SEVELAMER HYDROCHLORIDE	Glenmark Pharmaceuticals Inc., USA	2cd6512f-0edd-4a30-a4fa-aa996038633c	2026-01-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204724 application number: ANDA204724 ndc (product): 68462-447 ndc (product): 68462-446
sevelamer hydrochloride	SEVELAMER HYDROCHLORIDE	NorthStar RxLLC	a229a42a-4d1b-45df-aa77-71f44e0921ee	2025-08-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204724 application number: ANDA204724

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
60687-449	Sevelamer Hydrochloride	Sevelamer Hydrochloride	American Health Packaging	ANDA	Current
60687-449	Sevelamer Hydrochloride	Sevelamer Hydrochloride	American Health Packaging	ANDA	Current
60687-449	Sevelamer Hydrochloride	Sevelamer Hydrochloride	American Health Packaging	ANDA	Current
68462-446	sevelamer hydrochloride	sevelamer hydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-446	sevelamer hydrochloride	sevelamer hydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-446	sevelamer hydrochloride	sevelamer hydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-446	sevelamer hydrochloride	sevelamer hydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-446	sevelamer hydrochloride	sevelamer hydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-447	sevelamer hydrochloride	sevelamer hydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-447	sevelamer hydrochloride	sevelamer hydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-447	sevelamer hydrochloride	sevelamer hydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-447	sevelamer hydrochloride	sevelamer hydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-447	sevelamer hydrochloride	sevelamer hydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
57958	ORIG	2019-03-12