Application 201068

Type: ANDA
Sponsor: MYLAN PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SEVELAMER HYDROCHLORIDE	SEVELAMER HYDROCHLORIDE	UNKNOWN	UNKNOWN	No	No
002	SEVELAMER HYDROCHLORIDE	SEVELAMER HYDROCHLORIDE	TABLET;ORAL	800MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A201068-001	SEVELAMER HYDROCHLORIDE	SEVELAMER HYDROCHLORIDE	400MG	TABLET / ORAL			2020-12-14
A201068-002	SEVELAMER HYDROCHLORIDE	SEVELAMER HYDROCHLORIDE	800MG	TABLET / ORAL			2020-12-14

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 · 76 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A201068-001	SEVELAMER HYDROCHLORIDE	400MG	TABLET / ORAL	2020-12-14	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A201068-002	SEVELAMER HYDROCHLORIDE	800MG	TABLET / ORAL	2020-12-14	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A201068-001	SEVELAMER HYDROCHLORIDE	400MG	TABLET / ORAL	2020-12-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201068-002	SEVELAMER HYDROCHLORIDE	800MG	TABLET / ORAL	2020-12-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A201068-001	SEVELAMER HYDROCHLORIDE	400MG	TABLET / ORAL	2020-12-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201068-002	SEVELAMER HYDROCHLORIDE	800MG	TABLET / ORAL	2020-12-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201068-001	SEVELAMER HYDROCHLORIDE	400MG	TABLET / ORAL	2020-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201068-002	SEVELAMER HYDROCHLORIDE	800MG	TABLET / ORAL	2020-12-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201068-001	SEVELAMER HYDROCHLORIDE	400MG	TABLET / ORAL	2020-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201068-002	SEVELAMER HYDROCHLORIDE	800MG	TABLET / ORAL	2020-12-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201068-001	SEVELAMER HYDROCHLORIDE	400MG	TABLET / ORAL	2020-12-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201068-002	SEVELAMER HYDROCHLORIDE	800MG	TABLET / ORAL	2020-12-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201068-001	SEVELAMER HYDROCHLORIDE	400MG	TABLET / ORAL	2020-12-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201068-002	SEVELAMER HYDROCHLORIDE	800MG	TABLET / ORAL	2020-12-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201068-001	SEVELAMER HYDROCHLORIDE	400MG	TABLET / ORAL	2020-12-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201068-002	SEVELAMER HYDROCHLORIDE	800MG	TABLET / ORAL	2020-12-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201068-001	SEVELAMER HYDROCHLORIDE	400MG	TABLET / ORAL	2020-12-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201068-002	SEVELAMER HYDROCHLORIDE	800MG	TABLET / ORAL	2020-12-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201068-001	SEVELAMER HYDROCHLORIDE	400MG	TABLET / ORAL	2020-12-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201068-002	SEVELAMER HYDROCHLORIDE	800MG	TABLET / ORAL	2020-12-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201068-001	SEVELAMER HYDROCHLORIDE	400MG	TABLET / ORAL	2020-12-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201068-002	SEVELAMER HYDROCHLORIDE	800MG	TABLET / ORAL	2020-12-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201068-001	SEVELAMER HYDROCHLORIDE	400MG	TABLET / ORAL	2020-12-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201068-002	SEVELAMER HYDROCHLORIDE	800MG	TABLET / ORAL	2020-12-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201068-001	SEVELAMER HYDROCHLORIDE	400MG	TABLET / ORAL	2020-12-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201068-002	SEVELAMER HYDROCHLORIDE	800MG	TABLET / ORAL	2020-12-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201068-001	SEVELAMER HYDROCHLORIDE	400MG	TABLET / ORAL	2020-12-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201068-002	SEVELAMER HYDROCHLORIDE	800MG	TABLET / ORAL	2020-12-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201068-001	SEVELAMER HYDROCHLORIDE	400MG	TABLET / ORAL	2020-12-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201068-002	SEVELAMER HYDROCHLORIDE	800MG	TABLET / ORAL	2020-12-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201068-001	SEVELAMER HYDROCHLORIDE	400MG	TABLET / ORAL	2020-12-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201068-002	SEVELAMER HYDROCHLORIDE	800MG	TABLET / ORAL	2020-12-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201068-001	SEVELAMER HYDROCHLORIDE	400MG	TABLET / ORAL	2020-12-14	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201068-002	SEVELAMER HYDROCHLORIDE	800MG	TABLET / ORAL	2020-12-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201068-001	SEVELAMER HYDROCHLORIDE	400MG	TABLET / ORAL	2020-12-14	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201068-002	SEVELAMER HYDROCHLORIDE	800MG	TABLET / ORAL	2020-12-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201068-001	SEVELAMER HYDROCHLORIDE	400MG	TABLET / ORAL	2020-12-14	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201068-002	SEVELAMER HYDROCHLORIDE	800MG	TABLET / ORAL	2020-12-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201068-001	SEVELAMER HYDROCHLORIDE	400MG	TABLET / ORAL	2020-12-14	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201068-002	SEVELAMER HYDROCHLORIDE	800MG	TABLET / ORAL	2020-12-14	`4b0b4de00fa7…`

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 · 10 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	Name fallback brand name: Sevelamer Hydrochloride generic name: SEVELAMER HYDROCHLORIDE
sevelamer hydrochloride	SEVELAMER HYDROCHLORIDE	Cardinal Health 107, LLC	c13532a7-4c56-4084-839d-3dcfd4dc30f8	2026-02-26	Warnings, Adverse reactions	Name fallback brand name: sevelamer hydrochloride generic name: SEVELAMER HYDROCHLORIDE
sevelamer hydrochloride	SEVELAMER HYDROCHLORIDE	Major Pharmaceuticals	0500034d-458c-42c5-918d-9acd22f0c28b	2026-02-13	Warnings, Adverse reactions	Name fallback brand name: sevelamer hydrochloride generic name: SEVELAMER HYDROCHLORIDE
sevelamer hydrochloride	SEVELAMER HYDROCHLORIDE	Glenmark Pharmaceuticals Inc., USA	2cd6512f-0edd-4a30-a4fa-aa996038633c	2026-01-27	Warnings, Adverse reactions	Name fallback brand name: sevelamer hydrochloride generic name: SEVELAMER HYDROCHLORIDE
Sevelamer hydrochloride	SEVELAMER HYDROCHLORIDE	Lupin Pharmaceuticals, Inc.	a56c857e-bc39-484c-908d-f5957857efbb	2025-07-22	Warnings, Adverse reactions	Name fallback brand name: Sevelamer hydrochloride generic name: SEVELAMER HYDROCHLORIDE
Sevelamer Hydrochloride	SEVELAMER HYDROCHLORIDE	Bryant Ranch Prepack	35337152-9b92-40c0-e063-6294a90a8dd5	2025-05-15	Warnings, Adverse reactions	Name fallback brand name: Sevelamer Hydrochloride generic name: SEVELAMER HYDROCHLORIDE
Sevelamer Hydrochloride	SEVELAMER HYDROCHLORIDE	Bryant Ranch Prepack	3533d24b-508e-f012-e063-6394a90acaf5	2025-05-15	Warnings, Adverse reactions	Name fallback brand name: Sevelamer Hydrochloride generic name: SEVELAMER HYDROCHLORIDE
Sevelamer Hydrochloride	SEVELAMER HYDROCHLORIDE	Zydus Pharmaceuticals USA Inc.	ddecb552-5882-4e44-8fa7-37c9234dd1b9	2025-02-05	Warnings, Adverse reactions	Name fallback brand name: Sevelamer Hydrochloride generic name: SEVELAMER HYDROCHLORIDE
SEVELAMER HYDROCHLORIDE	SEVELAMER HYDROCHLORIDE	Aurobindo Pharma Limited	d8729e42-dbbd-4954-9ce0-298743a15a06	2024-01-24	Warnings, Adverse reactions	Name fallback brand name: SEVELAMER HYDROCHLORIDE generic name: SEVELAMER HYDROCHLORIDE
Sevelamer Hydrochloride	SEVELAMER HYDROCHLORIDE	Macleods Pharmaceuticals Limited	6926ebbe-2d74-4d5f-b642-c1bfe3a4e305	2023-06-05	Warnings, Adverse reactions	Name fallback brand name: Sevelamer Hydrochloride generic name: SEVELAMER HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.