Application 217319

Type: ANDA
Sponsor: CHARTWELL RX

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 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
A217319-001	SEVELAMER CARBONATE	SEVELAMER CARBONATE	800MG/PACKET	FOR SUSPENSION / ORAL	AB		2023-03-02
A217319-002	SEVELAMER CARBONATE	SEVELAMER CARBONATE	2.4GM/PACKET	FOR SUSPENSION / ORAL	AB		2023-03-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A217319-001	AB
A217319-002	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A217319-001	SEVELAMER CARBONATE	800MG/PACKET	FOR SUSPENSION / ORAL	AB		2023-03-02	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A217319-002	SEVELAMER CARBONATE	2.4GM/PACKET	FOR SUSPENSION / ORAL	AB		2023-03-02	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A217319-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A217319-002	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 3 · 43 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SEVELAMER CARBONATE	SEVELAMER CARBONATE	NorthStar RxLLC	5baf3742-5929-42f8-8865-6b3e92647d5b	2026-07-16	Warnings, Adverse reactions	Name fallback brand name: SEVELAMER CARBONATE generic name: SEVELAMER CARBONATE
Sevelamer Carbonate	SEVELAMER CARBONATE	Macleods Pharmaceuticals Limited	4c927d50-34a6-499b-b1c2-924d4eb73987	2026-07-10	Warnings, Adverse reactions	Name fallback brand name: Sevelamer Carbonate generic name: SEVELAMER CARBONATE
Sevelamer Carbonate	SEVELAMER CARBONATE	Marp Pharma	515ae758-ccba-5758-e063-6394a90a315b	2026-06-17	Warnings, Adverse reactions	Name fallback brand name: Sevelamer Carbonate generic name: SEVELAMER CARBONATE
SEVELAMER CARBONATE	SEVELAMER CARBONATE	INSIGNAMEDEX LLC	51ce2ed6-3acf-a6ea-e063-6294a90a21aa	2026-05-22	Warnings, Adverse reactions	Name fallback brand name: SEVELAMER CARBONATE generic name: SEVELAMER CARBONATE
REVENLA	SEVELAMER CARBONATE	INSIGNAMEDEX LLC	5167a163-c142-b73b-e063-6294a90abd49	2026-05-09		Name fallback generic name: SEVELAMER CARBONATE
SEVELAMER CARBONATE	SEVELAMER CARBONATE	PD-Rx Pharmaceuticals, Inc.	b72baeeb-b6f5-4fa1-bee8-9eb4bb74dc82	2026-04-17	Warnings, Adverse reactions	Name fallback brand name: SEVELAMER CARBONATE generic name: SEVELAMER CARBONATE
Sevelamer carbonate	SEVELAMER CARBONATE	Zydus Pharmaceuticals USA Inc.	2ccf62c6-dbad-416d-8e02-631795bd7517	2026-03-18	Warnings, Adverse reactions	Name fallback brand name: Sevelamer carbonate generic name: SEVELAMER CARBONATE
Sevelamer Carbonate	SEVELAMER CARBONATE	AvPAK	7f701cb4-3089-375f-e053-2991aa0a51b9	2026-01-20	Warnings, Adverse reactions	Name fallback brand name: Sevelamer Carbonate generic name: SEVELAMER CARBONATE
Sevelamer carbonate	SEVELAMER CARBONATE	Navinta LLC	d2f0c283-3e9d-41db-bd4d-83bd21f2a019	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Sevelamer carbonate generic name: SEVELAMER CARBONATE
Sevelamer Carbonate	SEVELAMER CARBONATE	Cardinal Health 107, LLC	65184825-adce-480e-a4c3-b21e37656cf4	2025-12-19	Warnings, Adverse reactions	Name fallback brand name: Sevelamer Carbonate generic name: SEVELAMER CARBONATE
SEVELAMER CARBONATE	SEVELAMER CARBONATE	Shandong Xinhua Pharmaceutical Co., Ltd.	f6455fa3-ad53-f6fd-e053-2a95a90a67db	2025-12-15	Warnings, Adverse reactions	Name fallback brand name: SEVELAMER CARBONATE generic name: SEVELAMER CARBONATE
SEVELAMER CARBONATE	SEVELAMER CARBONATE	AiPing Pharmaceutical, Inc.	0cade89a-38ca-4072-97a0-be09c6e058f4	2025-12-04	Warnings, Adverse reactions	Name fallback brand name: SEVELAMER CARBONATE generic name: SEVELAMER CARBONATE
Sevelamer Carbonate	SEVELAMER CARBONATE	Sanofi-Aventis U.S. LLC	3abc32fe-1bfc-4759-8f7c-36095e221b06	2025-11-25	Warnings, Adverse reactions	Name fallback brand name: Sevelamer Carbonate generic name: SEVELAMER CARBONATE
Renvela	SEVELAMER CARBONATE	Genzyme Corporation	e6328460-a57b-450b-a48c-6dcd4b476360	2025-11-25	Warnings, Adverse reactions	Name fallback generic name: SEVELAMER CARBONATE
Sevelamer Carbonate	SEVELAMER CARBONATE	Bryant Ranch Prepack	462a11b9-78a3-4d8b-ae5d-3d6528e4d743	2025-11-21	Warnings, Adverse reactions	Name fallback brand name: Sevelamer Carbonate generic name: SEVELAMER CARBONATE
Sevelamer Carbonate	SEVELAMER CARBONATE	Major Pharmaceuticals	42fefb90-6941-4539-8f32-df1896223450	2025-11-13	Warnings, Adverse reactions	Name fallback brand name: Sevelamer Carbonate generic name: SEVELAMER CARBONATE
Sevelamer Carbonate	SEVELAMER CARBONATE	AvKARE	41890246-efa5-524a-e063-6294a90a5ad9	2025-10-19	Warnings, Adverse reactions	Name fallback brand name: Sevelamer Carbonate generic name: SEVELAMER CARBONATE
Sevelamer Carbonate	SEVELAMER CARBONATE	Westminster Pharmaceuticals, LLC	45a955e9-94ac-48db-838c-74934eae245b	2025-10-01	Warnings, Adverse reactions	Name fallback brand name: Sevelamer Carbonate generic name: SEVELAMER CARBONATE
SEVELAMER CARBONATE	SEVELAMER CARBONATE	Macleods Pharmaceuticals Limited	48dbd7a7-32c7-45c1-ac8b-c478cf3282a6	2025-09-26	Warnings, Adverse reactions	Name fallback brand name: SEVELAMER CARBONATE generic name: SEVELAMER CARBONATE
Sevelamer Carbonate	SEVELAMER CARBONATE	Precision Dose, Inc.	09b5e422-18c9-49dc-be3d-5d24648184af	2025-08-11	Warnings, Adverse reactions	Name fallback brand name: Sevelamer Carbonate generic name: SEVELAMER CARBONATE