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 5 of 10 · 196 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Potassium Chloride	POTASSIUM CHLORIDE	Kesin Pharma Corporation	440dcbbb-bb31-d3fd-e063-6294a90ab2f7	2025-09-01	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	A-S Medication Solutions	8f6ea056-5e10-4de1-97f0-55f0655a6f78	2025-08-27	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	A-S Medication Solutions	8757d093-747b-4e97-af6d-4064b16178b2	2025-08-27	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	American Health Packaging	149770d0-3a2c-4e75-80a3-ec842907920d	2025-08-25	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Henry Schein, Inc.	bf8e8ac7-e6a8-4571-a0ea-7bcab89290f6	2025-08-12	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	AvKARE	3bdfced1-6e62-9e92-e063-6294a90a28aa	2025-08-08	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CHLORIDE
Potassium Chloride Extended-Release	POTASSIUM CHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	3be29fcc-765e-8653-e063-6394a90a59d5	2025-08-08	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CHLORIDE
KLOR-CON	POTASSIUM CHLORIDE	Upsher-Smith Laboratories, LLC	4340c3f2-ecf8-44cd-9b69-217f543e24e2	2025-08-08	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Slate Run Pharmaceuticals, LLC	94ae03cc-b620-0dbb-e053-2a95a90a922c	2025-08-07	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Slate Run Pharmaceuticals, LLC	0cc57ece-f15a-4160-a5ea-8d6fa9f9e754	2025-08-07	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	PD-Rx Pharmaceuticals, Inc.	47a87fb6-5e61-41c9-b759-10f7c74a67ce	2025-08-05	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CHLORIDE
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	American Health Packaging	7956883f-0d31-4081-bbea-d9ea320a193b	2025-08-04	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CHLORIDE
POTASSIUM CHLORIDE EXTENDED RELEASE	POTASSIUM CHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	3b403d60-4246-d765-e063-6394a90a12e8	2025-07-31	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CHLORIDE
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	A-S Medication Solutions	162a8ab5-76cf-48fa-8487-7780ed65647e	2025-07-31	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CHLORIDE
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	A-S Medication Solutions	14db14ba-fd0d-4b2a-9f1c-a62b3b82306f	2025-07-31	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	AvKARE	8baf3f25-c78b-6c08-e053-2995a90a667e	2025-07-23	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	AvKARE	8bb030b7-104a-373b-e053-2995a90ab580	2025-07-23	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Guardian Drug Company	296eda62-ea8e-7a0c-e063-6294a90a9274	2025-07-22	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Genus Lifesciences	14cd12ee-a4a3-465a-9550-58c9ef0e4f21	2025-07-21	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CHLORIDE
Potassium chloride	POTASSIUM CHLORIDE	Camber Pharmaceuticals, Inc.	fb2f6e74-4c1f-40c5-88a1-b88c069d4c75	2025-07-17	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.