Application 215725

Type: ANDA
Sponsor: RUBICON

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	TABLET, EXTENDED RELEASE;ORAL	10MEQ	No	No
002	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	TABLET, EXTENDED RELEASE;ORAL	20MEQ	No	No
003	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	TABLET, EXTENDED RELEASE;ORAL	15MEQ	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A215725-001	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3		2022-07-25
A215725-002	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3		2022-07-25
A215725-003	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL		RS	2024-08-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215725-001	AB3
A215725-002	AB3

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A215725-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3		2022-07-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215725-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3		2022-07-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215725-003	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL		RS	2024-08-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215725-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3		2022-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215725-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3		2022-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215725-003	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL		RS	2024-08-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215725-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3		2022-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215725-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3		2022-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215725-003	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL		RS	2024-08-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215725-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3		2022-07-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215725-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3		2022-07-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215725-003	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL		RS	2024-08-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215725-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3		2022-07-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215725-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3		2022-07-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215725-003	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL		RS	2024-08-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215725-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3		2022-07-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215725-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3		2022-07-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215725-003	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL		RS	2024-08-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215725-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3		2022-07-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215725-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3		2022-07-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215725-003	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL		RS	2024-08-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215725-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3		2022-07-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215725-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3		2022-07-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215725-003	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL		RS	2024-08-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215725-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3		2022-07-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215725-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3		2022-07-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215725-003	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL		RS	2024-08-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215725-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3		2022-07-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215725-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3		2022-07-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215725-003	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL		RS	2024-08-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215725-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3		2022-07-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215725-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3		2022-07-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215725-003	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL		RS	2024-08-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215725-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3		2022-07-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215725-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3		2022-07-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215725-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3		2022-07-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215725-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3		2022-07-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215725-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3		2022-07-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215725-002	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3		2022-07-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215725-001	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB3		2022-07-25	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 56 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	A215725-001	AB3	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215725-002	AB3	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215725-001	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215725-002	AB3	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215725-001	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215725-002	AB3	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215725-001	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215725-002	AB3	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215725-001	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215725-002	AB3	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215725-001	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215725-002	AB3	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215725-001	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215725-002	AB3	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215725-001	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215725-002	AB3	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215725-001	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215725-002	AB3	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215725-001	AB3	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215725-002	AB3	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215725-001	AB3	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215725-002	AB3	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215725-001	AB3	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215725-002	AB3	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215725-001	AB3	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215725-002	AB3	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215725-001	AB3	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215725-002	AB3	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215725-001	AB3	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A215725-002	AB3	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215725-001	AB3	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215725-002	AB3	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215725-001	AB3	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A215725-002	AB3	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215725-001	AB3	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A215725-002	AB3	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215725-001	AB3	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215725-002	AB3	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215725-001	AB3	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215725-002	AB3	1	`9b2671bbb829…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Potassium chloride	POTASSIUM CHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	42773f05-7c2c-1790-e063-6294a90a78b3	2025-11-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215725 application number: ANDA215725
Potassium chloride	POTASSIUM CHLORIDE	Advagen Pharma Ltd	8000e242-fe20-4d02-8f7d-97298857cf4c	2025-11-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215725 application number: ANDA215725 ndc (product): 72888-075 ndc (product): 72888-076
Potassium chloride	POTASSIUM CHLORIDE	A-S Medication Solutions	4a2173ba-556b-4ad7-be81-4da79b739490	2025-11-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215725 application number: ANDA215725
Potassium chloride	POTASSIUM CHLORIDE	A-S Medication Solutions	eb6b608f-5e51-4bc9-8339-c5d5264cba98	2025-11-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215725 application number: ANDA215725
Potassium chloride	POTASSIUM CHLORIDE	PD-Rx Pharmaceuticals, Inc.	9b26cc41-3725-4ef1-afdf-5992816d3b0d	2025-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215725 application number: ANDA215725
Potassium chloride	POTASSIUM CHLORIDE	PD-Rx Pharmaceuticals, Inc.	c2028705-9e5b-424b-983a-1c7a71dedd74	2025-05-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215725 application number: ANDA215725

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
72888-075	Potassium chloride	Potassium Chloride	Advagen Pharma Ltd	ANDA	Current
72888-076	Potassium chloride	Potassium Chloride	Advagen Pharma Ltd	ANDA	Current