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 10 of 10 · 200 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Potassium Chloride	POTASSIUM CHLORIDE	BluePoint Laboratories	73c911bb-4d39-4793-acba-90ed4b0eff46	2022-10-17	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	Dr. Reddys Laboratories, Inc.	dda82a38-0c08-4947-99b7-915c2949bf16	2022-08-29	Warnings, Adverse reactions	Name fallback brand name: POTASSIUM CHLORIDE generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Actavis Pharma, Inc.	db002ae3-f54c-40a4-9cb4-e5681bf426e3	2022-08-01	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Actavis Pharma, Inc.	ed5baaf6-270b-4dd3-b100-36030c0098fc	2022-08-01	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
KALIUM MURIATICUM 6X	POTASSIUM CHLORIDE	Seroyal USA	22c95b6a-dd5d-476e-e054-00144ff8d46c	2022-07-07	Warnings	Name fallback generic name: POTASSIUM CHLORIDE
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	B. Braun Medical Inc.	ab67b151-8368-4321-b562-bad5eff7b740	2022-02-21	Warnings, Adverse reactions	Name fallback brand name: POTASSIUM CHLORIDE generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Tris Pharma Inc	159ddd0b-847e-4ecc-b3b2-9634cbb4dfa9	2022-01-26	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Guardian Drug Company	3d460e84-27a0-485c-8b11-58d03d9064aa	2021-07-28	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Aurobindo Pharma Limited	deb6b462-397f-4527-ae26-40dc5d5857bc	2021-04-30	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Aurobindo Pharma Limited	d43beabe-b801-4319-ad36-9a80856b94bd	2021-04-29	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
potassium chloride	POTASSIUM CHLORIDE	Zydus Pharmaceuticals (USA) Inc.	51586c47-1aff-4ce6-8030-89f9eb1bc9ac	2021-02-08	Warnings, Adverse reactions	Name fallback brand name: potassium chloride generic name: POTASSIUM CHLORIDE
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	Lupin Pharmaceuticals,Inc.	28c49165-d8c9-443a-b000-953b8e1ec55c	2020-11-20	Warnings, Adverse reactions	Name fallback brand name: POTASSIUM CHLORIDE generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Genus Lifesciences Inc.	23d818e7-c076-40de-8dc1-0b51ba4be96a	2020-04-28	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Lupin Pharmaceuticals,Inc.	1bbacdbb-91fa-4897-a00c-1b293de27b83	2020-04-27	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Mylan Pharmaceuticals Inc.	c64ed4c0-1e27-42b3-9625-fb4e0d31e271	2020-04-15	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	BluePoint Laboratories	431ff2ef-567c-4b60-af43-f4da61febaad	2019-07-03	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE EXTENDED-RELEASE	Solco Healthcare LLC	f704b746-ab75-4484-8704-5baa94a07750	2019-04-30	Warnings, Adverse reactions	Name fallback brand name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Novel Laboratories, Inc.	ce4d4d39-8551-4789-8347-af763635922c	2018-11-28	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Northstar Rx LLC	dded25a9-3df4-463a-8685-d2bc03ea4edb	2018-07-16	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Glenmark Pharmaceuticals Inc., USA	5b054142-7372-4641-be27-dca630a97ad9	2016-04-29	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.