Application 206814

Type: NDA
Sponsor: GENUS LIFESCIENCES

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	SOLUTION;ORAL	20MEQ/15ML	Yes	No
002	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	SOLUTION;ORAL	40MEQ/15ML	Yes	Yes
003	POKONZA	POTASSIUM CHLORIDE	SOLUTION;ORAL	10MEQ/15ML	Yes	No

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
N206814-001	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	RLD	2014-12-22
N206814-002	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	RLD, RS	2014-12-22
N206814-003	POKONZA	POTASSIUM CHLORIDE	10MEQ/15ML	SOLUTION / ORAL		RLD	2025-11-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N206814-001	AA
N206814-002	AA

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N206814-001	12539314	2039-03-07		Drug product	2026-02-04
N206814-002	12539314	2039-03-07		Drug product	2026-02-04

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 · 88 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	N206814-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	RLD	2014-12-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206814-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	RLD, RS	2014-12-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206814-003	POKONZA	10MEQ/15ML	SOLUTION / ORAL		RLD	2025-11-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N206814-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	RLD	2014-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206814-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	RLD, RS	2014-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206814-003	POKONZA	10MEQ/15ML	SOLUTION / ORAL		RLD	2025-11-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206814-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	RLD	2014-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206814-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	RLD, RS	2014-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206814-003	POKONZA	10MEQ/15ML	SOLUTION / ORAL		RLD	2025-11-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206814-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	RLD	2014-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206814-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	RLD, RS	2014-12-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206814-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	RLD	2014-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206814-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	RLD, RS	2014-12-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206814-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	RLD	2014-12-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206814-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	RLD, RS	2014-12-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206814-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	RLD	2014-12-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206814-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	RLD, RS	2014-12-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206814-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	RLD	2014-12-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206814-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	RLD, RS	2014-12-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206814-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	RLD	2014-12-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206814-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	RLD, RS	2014-12-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206814-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	RLD	2014-12-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206814-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	RLD, RS	2014-12-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N206814-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	RLD	2014-12-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N206814-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	RLD, RS	2014-12-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206814-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	RLD	2014-12-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206814-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	RLD, RS	2014-12-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206814-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	RLD	2014-12-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206814-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	RLD, RS	2014-12-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206814-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	RLD	2014-12-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206814-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	RLD, RS	2014-12-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N206814-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	RLD	2014-12-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N206814-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	RLD, RS	2014-12-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206814-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	RLD	2014-12-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206814-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	RLD, RS	2014-12-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N206814-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	RLD	2014-12-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N206814-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	RLD, RS	2014-12-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N206814-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	RLD	2014-12-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N206814-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	RLD, RS	2014-12-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N206814-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	RLD	2014-12-22	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	N206814-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206814-002	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N206814-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206814-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206814-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206814-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206814-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206814-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206814-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206814-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206814-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206814-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206814-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206814-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206814-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206814-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206814-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206814-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206814-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206814-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N206814-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N206814-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206814-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206814-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206814-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206814-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206814-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206814-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N206814-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N206814-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206814-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206814-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N206814-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N206814-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N206814-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N206814-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N206814-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N206814-002	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N206814-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N206814-002	AA	1	`bb7c543d1eb4…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N206814-001	12539314	2039-03-07	Drug product	2026-02-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206814-002	12539314	2039-03-07	Drug product	2026-02-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N206814-001	12539314	2039-03-07	Drug product	2026-02-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206814-002	12539314	2039-03-07	Drug product	2026-02-04	`011fe1cb6892…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N206814-001	12539314	2039-03-07	Drug product	2026-02-04	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N206814-002	12539314	2039-03-07	Drug product	2026-02-04	`a50c72e98297…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
POKONZA potassium chloride	POTASSIUM CHLORIDE	Carwin Pharmaceutical Associates, LLC	2d938cbf-27aa-4f9c-a582-5564d3b72465	2026-01-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 206814 application number: NDA206814
Potassium Chloride	POTASSIUM CHLORIDE	Genus Lifesciences	14cd12ee-a4a3-465a-9550-58c9ef0e4f21	2025-07-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 206814 application number: NDA206814 ndc (product): 64950-320
Potassium Chloride	POTASSIUM CHLORIDE	Endo USA, Inc.	e5214432-3517-4a90-9412-036752bd1139	2025-02-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 206814 application number: NDA206814 ndc (product): 0603-1542 ndc (product): 0603-1543

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 31 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0603-1542	Potassium Chloride	Potassium Chloride	Par Pharmaceutical	NDA	Current
0603-1542	Potassium Chloride	Potassium Chloride	Par Pharmaceutical	NDA	Current
0603-1542	Potassium Chloride	Potassium Chloride	Par Pharmaceutical	NDA	Current
0603-1543	Potassium Chloride	Potassium Chloride	Par Pharmaceutical	NDA	Current
0603-1543	Potassium Chloride	Potassium Chloride	Par Pharmaceutical	NDA	Current
0603-1543	Potassium Chloride	Potassium Chloride	Par Pharmaceutical	NDA	Current
17856-1542	Potassium Chloride	Potassium Chloride	Atlantic Biologicals Corps	NDA	Current
17856-1542	Potassium Chloride	Potassium Chloride	Atlantic Biologicals Corps	NDA	Current
17856-1543	Potassium Chloride	Potassium Chloride	ATLANTIC BIOLOGICALS CORP.	NDA	Current
17856-1543	Potassium Chloride	Potassium Chloride	ATLANTIC BIOLOGICALS CORP.	NDA	Current
17856-1544	Potassium Chloride	Potassium Chloride	ATLANTIC BIOLOGICALS CORP.	NDA	Current
17856-1544	Potassium Chloride	Potassium Chloride	ATLANTIC BIOLOGICALS CORP.	NDA	Current
64950-320	Potassium Chloride	Potassium Chloride	Genus Lifesciences Inc.	NDA	Current
64950-320	Potassium Chloride	Potassium Chloride	Genus Lifesciences Inc.	NDA	Current
64950-320	Potassium Chloride	Potassium Chloride	Genus Lifesciences Inc.	NDA	Current
66689-047	Potassium Chloride	Potassium Chloride	VistaPharm, Inc.	NDA	Current
66689-047	Potassium Chloride	Potassium Chloride	VistaPharm, Inc.	NDA	Current
66689-047	Potassium Chloride	Potassium Chloride	VistaPharm, Inc.	NDA	Current
66689-047	Potassium Chloride	Potassium Chloride	VistaPharm, Inc.	NDA	Current
66689-047	Potassium Chloride	Potassium Chloride	VistaPharm, Inc.	NDA	Current
66689-047	Potassium Chloride	Potassium Chloride	VistaPharm, Inc.	NDA	Current
66689-047	Potassium Chloride	Potassium Chloride	VistaPharm, Inc.	NDA	Current
66689-047	Potassium Chloride	Potassium Chloride	VistaPharm, Inc.	NDA	Current
66689-048	Potassium Chloride	Potassium Chloride	VistaPharm, Inc.	NDA	Current
66689-048	Potassium Chloride	Potassium Chloride	VistaPharm, Inc.	NDA	Current
66689-048	Potassium Chloride	Potassium Chloride	VistaPharm, Inc.	NDA	Current
66689-048	Potassium Chloride	Potassium Chloride	VistaPharm, Inc.	NDA	Current
66689-048	Potassium Chloride	Potassium Chloride	VistaPharm, Inc.	NDA	Current
66689-048	Potassium Chloride	Potassium Chloride	VistaPharm, Inc.	NDA	Current
66689-048	Potassium Chloride	Potassium Chloride	VistaPharm, Inc.	NDA	Current
66689-048	Potassium Chloride	Potassium Chloride	VistaPharm, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
62078	SUPPL	2020-03-09
62054	SUPPL	2020-03-06
58836	SUPPL	2019-05-23
58833	SUPPL	2019-05-22
57614	SUPPL	2019-02-15
57587	SUPPL	2019-02-13
44949	ORIG	2015-03-10
43528	ORIG	2015-03-10
32829	ORIG	2014-12-30
19736	ORIG	2014-12-23