Application 017850

Type: NDA
Sponsor: APOTHECON

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	KLOTRIX	POTASSIUM CHLORIDE	TABLET, 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N017850-001	KLOTRIX	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL		Approved before 1982

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	N017850-001	KLOTRIX	10MEQ	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N017850-001	KLOTRIX	10MEQ	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017850-001	KLOTRIX	10MEQ	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017850-001	KLOTRIX	10MEQ	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017850-001	KLOTRIX	10MEQ	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017850-001	KLOTRIX	10MEQ	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017850-001	KLOTRIX	10MEQ	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017850-001	KLOTRIX	10MEQ	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017850-001	KLOTRIX	10MEQ	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017850-001	KLOTRIX	10MEQ	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017850-001	KLOTRIX	10MEQ	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017850-001	KLOTRIX	10MEQ	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017850-001	KLOTRIX	10MEQ	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017850-001	KLOTRIX	10MEQ	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017850-001	KLOTRIX	10MEQ	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017850-001	KLOTRIX	10MEQ	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017850-001	KLOTRIX	10MEQ	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017850-001	KLOTRIX	10MEQ	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017850-001	KLOTRIX	10MEQ	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017850-001	KLOTRIX	10MEQ	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017850-001	KLOTRIX	10MEQ	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017850-001	KLOTRIX	10MEQ	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017850-001	KLOTRIX	10MEQ	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017850-001	KLOTRIX	10MEQ	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017850-001	KLOTRIX	10MEQ	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017850-001	KLOTRIX	10MEQ	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017850-001	KLOTRIX	10MEQ	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017850-001	KLOTRIX	10MEQ	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017850-001	KLOTRIX	10MEQ	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017850-001	KLOTRIX	10MEQ	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017850-001	KLOTRIX	10MEQ	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017850-001	KLOTRIX	10MEQ	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017850-001	KLOTRIX	10MEQ	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017850-001	KLOTRIX	10MEQ	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017850-001	KLOTRIX	10MEQ	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017850-001	KLOTRIX	10MEQ	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017850-001	KLOTRIX	10MEQ	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017850-001	KLOTRIX	10MEQ	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017850-001	KLOTRIX	10MEQ	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N017850-001	KLOTRIX	10MEQ	TABLET, EXTENDED RELEASE / ORAL	Approved before 1982	`f41ea6bd6efb…`

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 2 of 10 · 196 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Potassium Chloride Extended-Release	POTASSIUM CHLORIDE	Bryant Ranch Prepack	ff44dcd5-b255-4d80-83ee-3c8f922c99eb	2026-03-11	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Amneal Pharmaceuticals of New York LLC	cd56e147-92d6-46ce-ae00-63fac08d49b5	2026-03-03	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	A-S Medication Solutions	2d67fc67-c99f-4df2-a1e7-4d369cce12c2	2026-02-23	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CHLORIDE
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	Major Pharmaceuticals	33ad1eb2-1f05-461c-b01d-82dee4231556	2026-02-11	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Major Pharmaceuticals	5c2e888c-2f1e-4d5a-a456-20774ca83302	2026-02-04	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CHLORIDE
Potassium Chloride Extended-Release	POTASSIUM CHLORIDE	Major Pharmaceuticals	7d74652b-3513-4ebb-8b47-10b3603d04a7	2026-02-04	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CHLORIDE
POTASSIUM CHLORIDE EXTENDED RELEASE	POTASSIUM CHLORIDE	Rising Pharma Holdings, Inc.	947c11ca-ca0c-42df-8cc5-3db06458ca5b	2026-02-01	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CHLORIDE
POKONZA potassium chloride	POTASSIUM CHLORIDE	Carwin Pharmaceutical Associates, LLC	2d938cbf-27aa-4f9c-a582-5564d3b72465	2026-01-22	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	AvKARE	755a4a08-04ff-d7d1-a6fc-b8aeff3ae2c6	2026-01-15	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Advagen Pharma Limited	d528c0c1-b81f-4f7a-8518-e6911b23c3eb	2026-01-13	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CHLORIDE
Sore Throat 911	POTASSIUM CHLORIDE	DelCorean, LLC	9ff8ff03-5921-cb3c-e053-2a95a90a094b	2026-01-13	Warnings	Name fallback generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	AvPAK	f32df7c0-33eb-e6d6-e053-2a95a90a2e8d	2026-01-09	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Baxter Healthcare Corporation	092ddee4-572d-4771-8d95-880cea01097e	2026-01-09	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CHLORIDE
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	Advagen Pharma Limited	a9e9d134-55d0-47ae-925f-de07e7ffa4b8	2026-01-07	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CHLORIDE
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	Advagen Pharma Ltd.	f4497c26-da16-45b0-975d-81f2c2132704	2026-01-07	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23b10bd6-11bc-495e-bb05-ec332a9b3f21	2026-01-06	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Northwind Health Company, LLC	f2b671c9-9874-2668-e053-2a95a90a1b46	2026-01-01	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Northwind Health Company, LLC	f3081031-8234-5732-e053-2995a90aebeb	2026-01-01	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Northwind Health Company, LLC	dae7c63d-eef0-58d0-e053-2a95a90a667e	2026-01-01	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Northwind Health Company, LLC	db4dc4ab-e0d4-7dc7-e053-2995a90ac46e	2026-01-01	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CHLORIDE

Reported adverse events (FAERS/openFDA)#

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