Application 201944

Type: ANDA
Sponsor: TRIS PHARMA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	8MEQ	No	No
002	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	10MEQ	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
A201944-001	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL			2016-03-04
A201944-002	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL			2016-03-04

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 · 86 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	A201944-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL		2016-03-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201944-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL		2016-03-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A201944-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL		2016-03-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201944-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL		2016-03-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201944-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL		2016-03-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201944-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL		2016-03-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201944-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL		2016-03-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201944-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL		2016-03-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201944-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL		2016-03-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201944-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL		2016-03-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201944-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL		2016-03-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201944-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL		2016-03-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201944-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL		2016-03-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201944-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL		2016-03-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201944-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL		2016-03-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201944-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL		2016-03-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201944-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL		2016-03-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201944-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL		2016-03-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201944-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL		2016-03-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201944-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL		2016-03-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201944-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL		2016-03-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201944-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL		2016-03-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201944-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL		2016-03-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201944-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL		2016-03-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201944-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL		2016-03-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201944-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL		2016-03-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201944-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL		2016-03-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201944-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL		2016-03-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201944-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL		2016-03-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201944-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL		2016-03-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201944-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL		2016-03-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201944-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL		2016-03-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201944-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL		2016-03-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201944-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL		2016-03-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201944-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-03-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201944-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-03-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201944-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-03-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201944-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-03-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201944-001	POTASSIUM CHLORIDE	8MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-03-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201944-002	POTASSIUM CHLORIDE	10MEQ	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-03-04	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-04-08 23:34 UTC	2022-04	A201944-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201944-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201944-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201944-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201944-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201944-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201944-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201944-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201944-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A201944-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201944-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201944-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201944-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A201944-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201944-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A201944-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201944-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A201944-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201944-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A201944-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201944-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A201944-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201944-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A201944-002	AB	1	`ea99ee380514…`

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 4 of 10 · 200 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Potassium Chloride Extended-Release	POTASSIUM CHLORIDE	A-S Medication Solutions	d486f982-a7d3-463d-a68d-89365ddaf5bb	2025-11-06	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CHLORIDE
Potassium chloride	POTASSIUM CHLORIDE	A-S Medication Solutions	4a2173ba-556b-4ad7-be81-4da79b739490	2025-11-06	Warnings, Adverse reactions	Name fallback brand name: Potassium chloride generic name: POTASSIUM CHLORIDE
Potassium Chloride Extended-Release	POTASSIUM CHLORIDE	Bryant Ranch Prepack	6fc9eef0-3dfc-4344-85c7-9f11d9b99b65	2025-11-06	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CHLORIDE
Potassium Chloride Extended-Release	POTASSIUM CHLORIDE	Bryant Ranch Prepack	1b64b0c9-31a2-4ee7-8818-66de906ebeda	2025-11-06	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	A-S Medication Solutions	0ac9b8dc-0c8e-4cdc-ab9d-bd8cab4f4958	2025-11-05	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
Potassium chloride	POTASSIUM CHLORIDE	A-S Medication Solutions	eb6b608f-5e51-4bc9-8339-c5d5264cba98	2025-11-05	Warnings, Adverse reactions	Name fallback brand name: Potassium chloride generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	ICU Medical Inc.	eb56a807-ea94-4edb-9811-a04b19568468	2025-10-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
Potassium chloride	POTASSIUM CHLORIDE	Macleods Pharmaceuticals Limited	e0562a05-4359-4256-87e3-fcde65a008cd	2025-10-18	Warnings, Adverse reactions	Name fallback brand name: Potassium chloride generic name: POTASSIUM CHLORIDE
KLOR-CON M	POTASSIUM CHLORIDE	Cardinal Health 107, LLC	ee3a1815-7325-4838-9764-fe1db68877b6	2025-10-17	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Strides Pharma Science Limited	f4e36462-3522-4130-8785-6c18871d2984	2025-10-10	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Northstar Rx LLC	fbed8c29-b3f1-4e53-b290-6f717290cecf	2025-10-07	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	PD-Rx Pharmaceuticals, Inc.	cc15ef60-6956-4d34-b86d-72cdd0c0c0bb	2025-10-02	Warnings, Adverse reactions	Name fallback brand name: POTASSIUM CHLORIDE generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Granules Pharmaceuticals Inc	c1f4832d-4d5c-8c49-e053-2a95a90ac9fe	2025-09-30	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Bryant Ranch Prepack	0e875691-7372-46ac-80a1-946e08b40061	2025-09-30	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Epic Pharma, LLC	00615fad-ad3b-46e8-a89d-48290d937ae2	2025-09-23	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Macleods Pharmaceuticals Limited	89d827c8-91af-4bfd-a846-62e55824e983	2025-09-22	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Major Pharmaceuticals	a9d68a40-75e3-4c5c-b5d7-1d6160527fa7	2025-09-22	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	542e16b0-44db-490f-b44e-4c88a6e3d8b8	2025-09-17	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Strides Pharma Science Limited	0224e5b3-3c49-4e6e-aa78-1abcc6969246	2025-09-17	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Major Pharmaceuticals	7c2274f2-5a7f-4a4a-8b7b-44f6ef9a84a4	2025-09-05	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE

Reported adverse events (FAERS/openFDA)#

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