Application 090313

Type: ANDA
Sponsor: ECI PHARMS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SODIUM POLYSTYRENE SULFONATE	SODIUM POLYSTYRENE SULFONATE	POWDER;ORAL, RECTAL	453.6GM/BOT	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
A090313-001	SODIUM POLYSTYRENE SULFONATE	SODIUM POLYSTYRENE SULFONATE	453.6GM/BOT	POWDER / ORAL, RECTAL	AA		2011-12-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090313-001	AA

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	A090313-001	SODIUM POLYSTYRENE SULFONATE	453.6GM/BOT	POWDER / ORAL, RECTAL	AA	2011-12-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090313-001	SODIUM POLYSTYRENE SULFONATE	453.6GM/BOT	POWDER / ORAL, RECTAL	AA	2011-12-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090313-001	SODIUM POLYSTYRENE SULFONATE	453.6GM/BOT	POWDER / ORAL, RECTAL	AA	2011-12-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090313-001	SODIUM POLYSTYRENE SULFONATE	453.6GM/BOT	POWDER / ORAL, RECTAL	AA	2011-12-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090313-001	SODIUM POLYSTYRENE SULFONATE	453.6GM/BOT	POWDER / ORAL, RECTAL	AA	2011-12-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090313-001	SODIUM POLYSTYRENE SULFONATE	453.6GM/BOT	POWDER / ORAL, RECTAL	AA	2011-12-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090313-001	SODIUM POLYSTYRENE SULFONATE	453.6GM/BOT	POWDER / ORAL, RECTAL	AA	2011-12-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090313-001	SODIUM POLYSTYRENE SULFONATE	453.6GM/BOT	POWDER / ORAL, RECTAL	AA	2011-12-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090313-001	SODIUM POLYSTYRENE SULFONATE	453.6GM/BOT	POWDER / ORAL, RECTAL	AA	2011-12-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090313-001	SODIUM POLYSTYRENE SULFONATE	453.6GM/BOT	POWDER / ORAL, RECTAL	AA	2011-12-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090313-001	SODIUM POLYSTYRENE SULFONATE	453.6GM/BOT	POWDER / ORAL, RECTAL	AA	2011-12-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090313-001	SODIUM POLYSTYRENE SULFONATE	453.6GM/BOT	POWDER / ORAL, RECTAL	AA	2011-12-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090313-001	SODIUM POLYSTYRENE SULFONATE	453.6GM/BOT	POWDER / ORAL, RECTAL	AA	2011-12-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090313-001	SODIUM POLYSTYRENE SULFONATE	453.6GM/BOT	POWDER / ORAL, RECTAL	AA	2011-12-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090313-001	SODIUM POLYSTYRENE SULFONATE	453.6GM/BOT	POWDER / ORAL, RECTAL	AA	2011-12-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090313-001	SODIUM POLYSTYRENE SULFONATE	453.6GM/BOT	POWDER / ORAL, RECTAL	AA	2011-12-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090313-001	SODIUM POLYSTYRENE SULFONATE	453.6GM/BOT	POWDER / ORAL, RECTAL	AA	2011-12-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090313-001	SODIUM POLYSTYRENE SULFONATE	453.6GM/BOT	POWDER / ORAL, RECTAL	AA	2011-12-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090313-001	SODIUM POLYSTYRENE SULFONATE	453.6GM/BOT	POWDER / ORAL, RECTAL	AA	2011-12-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090313-001	SODIUM POLYSTYRENE SULFONATE	453.6GM/BOT	POWDER / ORAL, RECTAL	AA	2011-12-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090313-001	SODIUM POLYSTYRENE SULFONATE	453.6GM/BOT	POWDER / ORAL, RECTAL	AA	2011-12-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090313-001	SODIUM POLYSTYRENE SULFONATE	453.6GM/BOT	POWDER / ORAL, RECTAL	AA	2011-12-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090313-001	SODIUM POLYSTYRENE SULFONATE	453.6GM/BOT	POWDER / ORAL, RECTAL	AA	2011-12-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090313-001	SODIUM POLYSTYRENE SULFONATE	453.6GM/BOT	POWDER / ORAL, RECTAL	AA	2011-12-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090313-001	SODIUM POLYSTYRENE SULFONATE	453.6GM/BOT	POWDER / ORAL, RECTAL	AA	2011-12-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090313-001	SODIUM POLYSTYRENE SULFONATE	453.6GM/BOT	POWDER / ORAL, RECTAL	AA	2011-12-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090313-001	SODIUM POLYSTYRENE SULFONATE	453.6GM/BOT	POWDER / ORAL, RECTAL	AA	2011-12-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090313-001	SODIUM POLYSTYRENE SULFONATE	453.6GM/BOT	POWDER / ORAL, RECTAL	AA	2011-12-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090313-001	SODIUM POLYSTYRENE SULFONATE	453.6GM/BOT	POWDER / ORAL, RECTAL	AA	2011-12-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090313-001	SODIUM POLYSTYRENE SULFONATE	453.6GM/BOT	POWDER / ORAL, RECTAL	AA	2011-12-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090313-001	SODIUM POLYSTYRENE SULFONATE	453.6GM/BOT	POWDER / ORAL, RECTAL	AA	2011-12-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090313-001	SODIUM POLYSTYRENE SULFONATE	453.6GM/BOT	POWDER / ORAL, RECTAL	AA	2011-12-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090313-001	SODIUM POLYSTYRENE SULFONATE	453.6GM/BOT	POWDER / ORAL, RECTAL	AA	2011-12-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090313-001	SODIUM POLYSTYRENE SULFONATE	453.6GM/BOT	POWDER / ORAL, RECTAL	AA	2011-12-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090313-001	SODIUM POLYSTYRENE SULFONATE	453.6GM/BOT	POWDER / ORAL, RECTAL	AA	2011-12-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090313-001	SODIUM POLYSTYRENE SULFONATE	453.6GM/BOT	POWDER / ORAL, RECTAL	AA	2011-12-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090313-001	SODIUM POLYSTYRENE SULFONATE	453.6GM/BOT	POWDER / ORAL, RECTAL	AA	2011-12-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090313-001	SODIUM POLYSTYRENE SULFONATE	453.6GM/BOT	POWDER / ORAL, RECTAL	AA	2011-12-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090313-001	SODIUM POLYSTYRENE SULFONATE	453.6GM/BOT	POWDER / ORAL, RECTAL	AA	2011-12-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090313-001	SODIUM POLYSTYRENE SULFONATE	453.6GM/BOT	POWDER / ORAL, RECTAL	AA	2011-12-21	`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	A090313-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090313-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090313-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090313-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090313-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090313-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090313-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090313-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090313-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090313-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090313-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090313-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090313-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090313-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090313-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090313-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090313-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090313-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090313-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090313-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090313-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090313-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090313-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090313-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090313-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090313-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090313-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090313-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090313-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090313-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090313-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090313-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090313-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090313-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090313-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090313-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090313-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090313-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090313-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090313-001	AA	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 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sodium Polystyrene Sulfonate	SODIUM POLYSTYRENE SULFONATE	Cardinal Health 107, LLC	3c3b02a3-9a75-40a5-889d-97318faf881f	2025-10-29	Warnings, Adverse reactions	Name fallback brand name: Sodium Polystyrene Sulfonate generic name: SODIUM POLYSTYRENE SULFONATE
SODIUM POLYSTYRENE SULFONATE	SODIUM POLYSTYRENE SULFONATE	Bryant Ranch Prepack	d6016e9d-dec6-4f14-b10b-7ec1aba3964a	2025-10-21	Warnings, Adverse reactions	Name fallback brand name: SODIUM POLYSTYRENE SULFONATE generic name: SODIUM POLYSTYRENE SULFONATE
Kionex	SODIUM POLYSTYRENE SULFONATE	ANI Pharmaceuticals, Inc.	676c3d81-d575-43f6-8748-e04b7c0cafeb	2025-09-19	Warnings, Adverse reactions	Name fallback generic name: SODIUM POLYSTYRENE SULFONATE
Sodium Polystyrene Sulfonate	SODIUM POLYSTYRENE SULFONATE	ATLANTIC BIOLOGICALS CORP.	2d95d23e-94c8-4975-99f5-ce746dfbb60e	2025-05-27	Warnings, Adverse reactions	Name fallback brand name: Sodium Polystyrene Sulfonate generic name: SODIUM POLYSTYRENE SULFONATE
SODIUM POLYSTYRENE SULFONATE	SODIUM POLYSTYRENE SULFONATE	Bryant Ranch Prepack	9a50c6d4-e619-438d-8af9-bb758ea7ba7e	2025-05-12	Warnings, Adverse reactions	Name fallback brand name: SODIUM POLYSTYRENE SULFONATE generic name: SODIUM POLYSTYRENE SULFONATE
Sodium Polystyrene Sulfonate	SODIUM POLYSTYRENE SULFONATE	Burel Pharmaceuticals, LLC	8bbeae67-a7ff-4fa6-b21e-fb8617cd9197	2025-05-01	Warnings, Adverse reactions	Name fallback brand name: Sodium Polystyrene Sulfonate generic name: SODIUM POLYSTYRENE SULFONATE
SODIUM POLYSTYRENE SULFONATE	SODIUM POLYSTYRENE SULFONATE	Bryant Ranch Prepack	03a0b525-5e48-4e76-b1fa-700eab10d20a	2024-04-12	Warnings, Adverse reactions	Name fallback brand name: SODIUM POLYSTYRENE SULFONATE generic name: SODIUM POLYSTYRENE SULFONATE
SODIUM POLYSTYRENE SULFONATE	SODIUM POLYSTYRENE SULFONATE	Bryant Ranch Prepack	fe1eaaea-0697-4790-8f14-b9db08d42257	2024-03-15	Warnings, Adverse reactions	Name fallback brand name: SODIUM POLYSTYRENE SULFONATE generic name: SODIUM POLYSTYRENE SULFONATE
Sodium Polystyrene Sulfonate	SODIUM POLYSTYRENE SULFONATE	KVK-Tech, Inc.	905c3ee5-d1a7-4deb-a345-4a42296704fa	2024-02-23	Warnings, Adverse reactions	Name fallback brand name: Sodium Polystyrene Sulfonate generic name: SODIUM POLYSTYRENE SULFONATE
Sodium Polystyrene Sulfonate	SODIUM POLYSTYRENE SULFONATE	Epic Pharma, LLC	61cc890b-eb3d-494c-ae45-629a27e721ce	2023-11-29	Warnings, Adverse reactions	Name fallback brand name: Sodium Polystyrene Sulfonate generic name: SODIUM POLYSTYRENE SULFONATE
Sodium Polystyrene Sulfonate	SODIUM POLYSTYRENE SULFONATE	Chartwell RX, LLC	e910a2f9-07ee-4e8f-95bd-f124e1306ff7	2023-10-05	Warnings, Adverse reactions	Name fallback brand name: Sodium Polystyrene Sulfonate generic name: SODIUM POLYSTYRENE SULFONATE
SODIUM POLYSTYRENE SULFONATE	SODIUM POLYSTYRENE SULFONATE	Bryant Ranch Prepack	cae5e7d2-c6ca-485e-963e-1a147e5b11c3	2023-03-15	Warnings, Adverse reactions	Name fallback brand name: SODIUM POLYSTYRENE SULFONATE generic name: SODIUM POLYSTYRENE SULFONATE
Sodium Polystyrene Sulfonate	SODIUM POLYSTYRENE SULFONATE	PuraCap Laboratories, LLC	875d5288-db99-4440-8290-d9192bde6eee	2022-12-28	Warnings, Adverse reactions	Name fallback brand name: Sodium Polystyrene Sulfonate generic name: SODIUM POLYSTYRENE SULFONATE
SODIUM POLYSTYRENE SULFONATE	SODIUM POLYSTYRENE SULFONATE	SUNRISE PHARMACEUTICAL, INC.	c73b9661-2378-4336-8be0-098e7c1ae522	2022-08-12	Warnings, Adverse reactions	Name fallback brand name: SODIUM POLYSTYRENE SULFONATE generic name: SODIUM POLYSTYRENE SULFONATE
Sodium Polystyrene Sulfonate	SODIUM POLYSTYRENE SULFONATE	CMP Pharma, Inc.	12d48dcf-07bd-4b06-bd6c-7543f1be8357	2021-08-15	Warnings, Adverse reactions	Name fallback brand name: Sodium Polystyrene Sulfonate generic name: SODIUM POLYSTYRENE SULFONATE
Sodium Polystyrene Sulfonate	SODIUM POLYSTYRENE SULFONATE	CMP Pharma, Inc.	2017bfbe-cda8-46f1-b4f1-9c086c3249a9	2021-02-01	Warnings, Adverse reactions	Name fallback brand name: Sodium Polystyrene Sulfonate generic name: SODIUM POLYSTYRENE SULFONATE

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
17856-0831	Sodium Polystyrene Sulfonate	Sodium Polystyrene Sulfonate	ATLANTIC BIOLOGICALS CORP.	ANDA	Current
17856-0831	Sodium Polystyrene Sulfonate	Sodium Polystyrene Sulfonate	ATLANTIC BIOLOGICALS CORP.	ANDA	Current
50488-5001	Sodium Polystyrene Sulfonate	Sodium Polystyrene Sulfonate	Alexso, Inc	ANDA	Current
51293-831	Sodium Polystyrene Sulfonate	Sodium Polystyrene Sulfonate	ECI Pharmaceuticals, LLC	ANDA	Current
51293-831	Sodium Polystyrene Sulfonate	Sodium Polystyrene Sulfonate	ECI Pharmaceuticals, LLC	ANDA	Current
51293-831	Sodium Polystyrene Sulfonate	Sodium Polystyrene Sulfonate	ECI Pharmaceuticals, LLC	ANDA	Current
51293-831	Sodium Polystyrene Sulfonate	Sodium Polystyrene Sulfonate	ECI Pharmaceuticals, LLC	ANDA	Current
63629-2031	Sodium Polystyrene Sulfonate	Sodium Polystyrene Sulfonate	Bryant Ranch Prepack	ANDA	Current
63629-2031	Sodium Polystyrene Sulfonate	Sodium Polystyrene Sulfonate	Bryant Ranch Prepack	ANDA	Current
63629-2031	Sodium Polystyrene Sulfonate	Sodium Polystyrene Sulfonate	Bryant Ranch Prepack	ANDA	Current
70166-712	Sodium Polystyrene Sulfonate	Sodium Polystyrene Sulfonate	LOHXA	ANDA	Current