Application 201513

Type: ANDA
Sponsor: LUPIN LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SEVELAMER CARBONATE	SEVELAMER CARBONATE	FOR SUSPENSION;ORAL	800MG/PACKET	No	No
002	SEVELAMER CARBONATE	SEVELAMER CARBONATE	FOR SUSPENSION;ORAL	2.4GM/PACKET	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A201513-001	SEVELAMER CARBONATE	SEVELAMER CARBONATE	800MG/PACKET	FOR SUSPENSION / ORAL			2021-12-23
A201513-002	SEVELAMER CARBONATE	SEVELAMER CARBONATE	2.4GM/PACKET	FOR SUSPENSION / ORAL			2021-12-23

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 · 68 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
2026-09-14 22:38:34	2026-08	A201513-001	SEVELAMER CARBONATE	800MG/PACKET	FOR SUSPENSION / ORAL		2021-12-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201513-002	SEVELAMER CARBONATE	2.4GM/PACKET	FOR SUSPENSION / ORAL		2021-12-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A201513-001	SEVELAMER CARBONATE	800MG/PACKET	FOR SUSPENSION / ORAL		2021-12-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201513-002	SEVELAMER CARBONATE	2.4GM/PACKET	FOR SUSPENSION / ORAL		2021-12-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201513-001	SEVELAMER CARBONATE	800MG/PACKET	FOR SUSPENSION / ORAL		2021-12-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201513-002	SEVELAMER CARBONATE	2.4GM/PACKET	FOR SUSPENSION / ORAL		2021-12-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201513-001	SEVELAMER CARBONATE	800MG/PACKET	FOR SUSPENSION / ORAL		2021-12-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201513-002	SEVELAMER CARBONATE	2.4GM/PACKET	FOR SUSPENSION / ORAL		2021-12-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201513-001	SEVELAMER CARBONATE	800MG/PACKET	FOR SUSPENSION / ORAL		2021-12-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201513-002	SEVELAMER CARBONATE	2.4GM/PACKET	FOR SUSPENSION / ORAL		2021-12-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201513-001	SEVELAMER CARBONATE	800MG/PACKET	FOR SUSPENSION / ORAL		2021-12-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201513-002	SEVELAMER CARBONATE	2.4GM/PACKET	FOR SUSPENSION / ORAL		2021-12-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201513-001	SEVELAMER CARBONATE	800MG/PACKET	FOR SUSPENSION / ORAL		2021-12-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201513-002	SEVELAMER CARBONATE	2.4GM/PACKET	FOR SUSPENSION / ORAL		2021-12-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201513-001	SEVELAMER CARBONATE	800MG/PACKET	FOR SUSPENSION / ORAL		2021-12-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201513-002	SEVELAMER CARBONATE	2.4GM/PACKET	FOR SUSPENSION / ORAL		2021-12-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201513-001	SEVELAMER CARBONATE	800MG/PACKET	FOR SUSPENSION / ORAL		2021-12-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201513-002	SEVELAMER CARBONATE	2.4GM/PACKET	FOR SUSPENSION / ORAL		2021-12-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201513-001	SEVELAMER CARBONATE	800MG/PACKET	FOR SUSPENSION / ORAL		2021-12-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201513-002	SEVELAMER CARBONATE	2.4GM/PACKET	FOR SUSPENSION / ORAL		2021-12-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201513-001	SEVELAMER CARBONATE	800MG/PACKET	FOR SUSPENSION / ORAL		2021-12-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201513-002	SEVELAMER CARBONATE	2.4GM/PACKET	FOR SUSPENSION / ORAL		2021-12-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201513-001	SEVELAMER CARBONATE	800MG/PACKET	FOR SUSPENSION / ORAL		2021-12-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201513-002	SEVELAMER CARBONATE	2.4GM/PACKET	FOR SUSPENSION / ORAL		2021-12-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201513-001	SEVELAMER CARBONATE	800MG/PACKET	FOR SUSPENSION / ORAL		2021-12-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201513-002	SEVELAMER CARBONATE	2.4GM/PACKET	FOR SUSPENSION / ORAL		2021-12-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201513-001	SEVELAMER CARBONATE	800MG/PACKET	FOR SUSPENSION / ORAL		2021-12-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201513-002	SEVELAMER CARBONATE	2.4GM/PACKET	FOR SUSPENSION / ORAL		2021-12-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201513-001	SEVELAMER CARBONATE	800MG/PACKET	FOR SUSPENSION / ORAL		2021-12-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201513-002	SEVELAMER CARBONATE	2.4GM/PACKET	FOR SUSPENSION / ORAL		2021-12-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201513-001	SEVELAMER CARBONATE	800MG/PACKET	FOR SUSPENSION / ORAL		2021-12-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201513-002	SEVELAMER CARBONATE	2.4GM/PACKET	FOR SUSPENSION / ORAL		2021-12-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201513-001	SEVELAMER CARBONATE	800MG/PACKET	FOR SUSPENSION / ORAL	AB	2021-12-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201513-002	SEVELAMER CARBONATE	2.4GM/PACKET	FOR SUSPENSION / ORAL	AB	2021-12-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201513-001	SEVELAMER CARBONATE	800MG/PACKET	FOR SUSPENSION / ORAL	AB	2021-12-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201513-002	SEVELAMER CARBONATE	2.4GM/PACKET	FOR SUSPENSION / ORAL	AB	2021-12-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201513-001	SEVELAMER CARBONATE	800MG/PACKET	FOR SUSPENSION / ORAL	AB	2021-12-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201513-002	SEVELAMER CARBONATE	2.4GM/PACKET	FOR SUSPENSION / ORAL	AB	2021-12-23	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A201513-001	SEVELAMER CARBONATE	800MG/PACKET	FOR SUSPENSION / ORAL	AB	2021-12-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201513-002	SEVELAMER CARBONATE	2.4GM/PACKET	FOR SUSPENSION / ORAL	AB	2021-12-23	`bb7c543d1eb4…`

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	A201513-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201513-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201513-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201513-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201513-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201513-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A201513-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201513-002	AB	1	`bb7c543d1eb4…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201513-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201513-002	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 2 of 3 · 41 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SEVELAMER CARBONATE	SEVELAMER CARBONATE	Strides Pharma Science Limited	c17bff97-8347-43f8-822e-1cb9736562b6	2025-07-09	Warnings, Adverse reactions	Name fallback brand name: SEVELAMER CARBONATE generic name: SEVELAMER CARBONATE
Sevelamer Carbonate	SEVELAMER CARBONATE	ATLANTIC BIOLOGICALS CORP.	07b709fd-a2a1-4ff1-ad19-827d38e84562	2025-06-27	Warnings, Adverse reactions	Name fallback brand name: Sevelamer Carbonate generic name: SEVELAMER CARBONATE
Sevelamer Carbonate	SEVELAMER CARBONATE	Golden State Medical Supply, Inc.	3779296e-35bc-5b03-e063-6294a90a0214	2025-06-13	Warnings, Adverse reactions	Name fallback brand name: Sevelamer Carbonate generic name: SEVELAMER CARBONATE
Sevelamer Carbonate	SEVELAMER CARBONATE	Cardinal Health 107, LLC	61d073ec-51a4-48c7-8762-25fdd00fe6ac	2025-06-06	Warnings, Adverse reactions	Name fallback brand name: Sevelamer Carbonate generic name: SEVELAMER CARBONATE
Sevelamer Carbonate	SEVELAMER CARBONATE	DR. REDDY'S LABORATORIES LIMITED	0085356d-5fec-3cce-2bd3-108be70e515d	2025-04-01	Warnings, Adverse reactions	Name fallback brand name: Sevelamer Carbonate generic name: SEVELAMER CARBONATE
Sevelamer Carbonate	SEVELAMER CARBONATE	Bionpharma Inc.	c3cf4807-ae5f-528e-e053-2a95a90ac640	2024-08-22	Warnings, Adverse reactions	Name fallback brand name: Sevelamer Carbonate generic name: SEVELAMER CARBONATE
Sevelamer Carbonate	SEVELAMER CARBONATE	TWi Pharmaceuticals, Inc.	05b076d9-6516-4538-8e05-9709a677ed2f	2024-08-21	Warnings, Adverse reactions	Name fallback brand name: Sevelamer Carbonate generic name: SEVELAMER CARBONATE
Sevelamer carbonate	SEVELAMER CARBONATE	Zydus Lifesciences Limited	cbdee883-ccc7-4c55-965d-b608a214b375	2024-08-12		Name fallback brand name: Sevelamer carbonate generic name: SEVELAMER CARBONATE
Sevelamer Carbonate	SEVELAMER CARBONATE	NCS HealthCare of KY, LLC dba Vangard Labs	ccfde4dd-b258-4baf-995b-a24bed8c84d7	2024-08-09	Warnings, Adverse reactions	Name fallback brand name: Sevelamer Carbonate generic name: SEVELAMER CARBONATE
Sevelamer Carbonate	SEVELAMER CARBONATE	American Health Packaging	bd0a89ab-91c4-42b3-aa88-1e3295d0d344	2024-07-30	Warnings, Adverse reactions	Name fallback brand name: Sevelamer Carbonate generic name: SEVELAMER CARBONATE
Sevelamer Carbonate	SEVELAMER CARBONATE	Proficient Rx LP	ee9da697-2d55-48e5-8e03-c64c8aaf1fb8	2024-05-01	Warnings, Adverse reactions	Name fallback brand name: Sevelamer Carbonate generic name: SEVELAMER CARBONATE
Sevelamer Carbonate	SEVELAMER CARBONATE	NorthStar Rx LLC	9b4d0720-f4e7-4b4f-affc-57ce8bb0b722	2024-04-24	Warnings, Adverse reactions	Name fallback brand name: Sevelamer Carbonate generic name: SEVELAMER CARBONATE
Sevelamer Carbonate	SEVELAMER CARBONATE	Aurobindo Pharma Limited	ab0cd45f-0c4b-4ce7-bf8e-5f98d43feaab	2024-04-04	Warnings, Adverse reactions	Name fallback brand name: Sevelamer Carbonate generic name: SEVELAMER CARBONATE
SEVELAMER CARBONATE	SEVELAMER CARBONATE	Aurobindo Pharma Limited	ea201bff-cdfb-4304-bdb1-d05c1dac2677	2023-12-08	Warnings, Adverse reactions	Name fallback brand name: SEVELAMER CARBONATE generic name: SEVELAMER CARBONATE
Sevelamer carbonate	SEVELAMER CARBONATE	Zydus Pharmaceuticals USA Inc.	71f61492-8971-424a-8415-dfd2e15d05d9	2023-11-07	Warnings, Adverse reactions	Name fallback brand name: Sevelamer carbonate generic name: SEVELAMER CARBONATE
Sevelamer Carbonate	SEVELAMER CARBONATE	Amneal Pharmaceuticals LLC	94d8cfb1-ff2a-4956-8954-17635ac505d9	2023-11-05	Warnings, Adverse reactions	Name fallback brand name: Sevelamer Carbonate generic name: SEVELAMER CARBONATE
Sevelamer carbonate	SEVELAMER CARBONATE	Cipla USA Inc.	134f32c1-b5d5-44d0-9da5-85033e99320a	2023-01-18	Warnings, Adverse reactions	Name fallback brand name: Sevelamer carbonate generic name: SEVELAMER CARBONATE
sevelamer carbonate	SEVELAMER CARBONATE	Amneal Pharmaceuticals of New York LLC	da5239fe-060b-4469-95ac-173adec43b9c	2020-12-31	Warnings, Adverse reactions	Name fallback brand name: sevelamer carbonate generic name: SEVELAMER CARBONATE
Sevelamer carbonate	SEVELAMER CARBONATE	Exelan Pharmaceuticals Inc.	f8947f65-57be-4af7-b0e7-17666f496d01	2020-10-09	Warnings, Adverse reactions	Name fallback brand name: Sevelamer carbonate generic name: SEVELAMER CARBONATE
Sevelamer carbonate	SEVELAMER CARBONATE	Cipla USA Inc.	f63450bd-d075-4810-a277-e8bc41e4a5af	2018-12-19	Warnings, Adverse reactions	Name fallback brand name: Sevelamer carbonate generic name: SEVELAMER CARBONATE

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68180-456	SEVELAMER CARBONATE	SEVELAMER CARBONATE	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-457	SEVELAMER CARBONATE	SEVELAMER CARBONATE	Lupin Pharmaceuticals, Inc.	ANDA	Current