Application 040905

Type: ANDA
Sponsor: KVK TECH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	KALEXATE	SODIUM POLYSTYRENE SULFONATE	POWDER;ORAL, RECTAL	454GM/BOT	No	Yes
002	KALEXATE	SODIUM POLYSTYRENE SULFONATE	POWDER;ORAL, RECTAL	15GM/BOT	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
A040905-001	KALEXATE	SODIUM POLYSTYRENE SULFONATE	454GM/BOT	POWDER / ORAL, RECTAL	AA	RS	2009-03-30
A040905-002	KALEXATE	SODIUM POLYSTYRENE SULFONATE	15GM/BOT	POWDER / ORAL, RECTAL			2015-04-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040905-001	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 3 · 82 observed 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
2026-02-19 14:30 UTC	2026-02	A040905-001	KALEXATE	454GM/BOT	POWDER / ORAL, RECTAL	AA	RS	2009-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040905-002	KALEXATE	15GM/BOT	POWDER / ORAL, RECTAL			2015-04-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040905-001	KALEXATE	454GM/BOT	POWDER / ORAL, RECTAL	AA	RS	2009-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040905-002	KALEXATE	15GM/BOT	POWDER / ORAL, RECTAL			2015-04-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040905-001	KALEXATE	454GM/BOT	POWDER / ORAL, RECTAL	AA	RS	2009-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040905-002	KALEXATE	15GM/BOT	POWDER / ORAL, RECTAL			2015-04-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040905-001	KALEXATE	454GM/BOT	POWDER / ORAL, RECTAL	AA	RS	2009-03-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040905-002	KALEXATE	15GM/BOT	POWDER / ORAL, RECTAL			2015-04-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040905-001	KALEXATE	454GM/BOT	POWDER / ORAL, RECTAL	AA	RS	2009-03-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040905-002	KALEXATE	15GM/BOT	POWDER / ORAL, RECTAL			2015-04-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040905-001	KALEXATE	454GM/BOT	POWDER / ORAL, RECTAL	AA	RS	2009-03-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040905-002	KALEXATE	15GM/BOT	POWDER / ORAL, RECTAL			2015-04-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040905-001	KALEXATE	454GM/BOT	POWDER / ORAL, RECTAL	AA	RS	2009-03-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040905-002	KALEXATE	15GM/BOT	POWDER / ORAL, RECTAL			2015-04-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040905-001	KALEXATE	454GM/BOT	POWDER / ORAL, RECTAL	AA	RS	2009-03-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040905-002	KALEXATE	15GM/BOT	POWDER / ORAL, RECTAL			2015-04-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040905-001	KALEXATE	454GM/BOT	POWDER / ORAL, RECTAL	AA	RS	2009-03-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040905-002	KALEXATE	15GM/BOT	POWDER / ORAL, RECTAL			2015-04-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040905-001	KALEXATE	454GM/BOT	POWDER / ORAL, RECTAL	AA	RS	2009-03-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040905-002	KALEXATE	15GM/BOT	POWDER / ORAL, RECTAL			2015-04-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040905-001	KALEXATE	454GM/BOT	POWDER / ORAL, RECTAL	AA	RS	2009-03-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040905-002	KALEXATE	15GM/BOT	POWDER / ORAL, RECTAL			2015-04-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040905-001	KALEXATE	454GM/BOT	POWDER / ORAL, RECTAL	AA	RS	2009-03-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040905-002	KALEXATE	15GM/BOT	POWDER / ORAL, RECTAL			2015-04-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040905-001	KALEXATE	454GM/BOT	POWDER / ORAL, RECTAL	AA	RS	2009-03-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040905-002	KALEXATE	15GM/BOT	POWDER / ORAL, RECTAL			2015-04-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040905-001	KALEXATE	454GM/BOT	POWDER / ORAL, RECTAL	AA	RS	2009-03-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040905-002	KALEXATE	15GM/BOT	POWDER / ORAL, RECTAL			2015-04-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040905-001	KALEXATE	454GM/BOT	POWDER / ORAL, RECTAL	AA	RS	2009-03-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040905-002	KALEXATE	15GM/BOT	POWDER / ORAL, RECTAL			2015-04-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040905-001	KALEXATE	454GM/BOT	POWDER / ORAL, RECTAL	AA	RS	2009-03-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040905-002	KALEXATE	15GM/BOT	POWDER / ORAL, RECTAL			2015-04-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040905-001	KALEXATE	454GM/BOT	POWDER / ORAL, RECTAL	AA	RS	2009-03-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040905-002	KALEXATE	15GM/BOT	POWDER / ORAL, RECTAL			2015-04-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040905-001	KALEXATE	454GM/BOT	POWDER / ORAL, RECTAL	AA	RS	2009-03-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040905-002	KALEXATE	15GM/BOT	POWDER / ORAL, RECTAL			2015-04-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040905-001	KALEXATE	454GM/BOT	POWDER / ORAL, RECTAL	AA	RS	2009-03-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040905-002	KALEXATE	15GM/BOT	POWDER / ORAL, RECTAL			2015-04-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040905-001	KALEXATE	454GM/BOT	POWDER / ORAL, RECTAL	AA	RS	2009-03-30	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040905-002	KALEXATE	15GM/BOT	POWDER / ORAL, RECTAL			2015-04-03	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A040905-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040905-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040905-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040905-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040905-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040905-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040905-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040905-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040905-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040905-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040905-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040905-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040905-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040905-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040905-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040905-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040905-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040905-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040905-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040905-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040905-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040905-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040905-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040905-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040905-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040905-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040905-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040905-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040905-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040905-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040905-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040905-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040905-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040905-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040905-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040905-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040905-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040905-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040905-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040905-001	AA	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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sodium Polystyrene Sulfonate	SODIUM POLYSTYRENE SULFONATE	KVK-Tech, Inc.	905c3ee5-d1a7-4deb-a345-4a42296704fa	2024-02-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040905 application number: ANDA040905 ndc (product): 10702-036

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10702-036	Sodium Polystyrene Sulfonate	Sodium Polystyrene Sulfonate	KVK-Tech, Inc.	ANDA	Current
17856-0036	Sodium Polystyrene Sulfonate	Sodium Polystyrene Sulfonate	Atlantic Biologicals Corps	ANDA	Current
17856-1136	Sodium Polystyrene Sulfonate	Sodium Polystyrene Sulfonate	ATLANTIC BIOLOGICALS CORP	ANDA	Current
17856-1136	Sodium Polystyrene Sulfonate	Sodium Polystyrene Sulfonate	ATLANTIC BIOLOGICALS CORP	ANDA	Current