Application 208019

Type: NDA
Sponsor: PHARMA RES SOFTWARE

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N208019-001	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	20MEQ	FOR SOLUTION / ORAL	AA	RLD	2015-08-19
N208019-002	POKONZA	POTASSIUM CHLORIDE	10MEQ	FOR SOLUTION / ORAL		RLD	2023-08-25
N208019-003	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	40MEQ	FOR SOLUTION / ORAL		RLD	2023-08-25
N208019-004	POKONZA	POTASSIUM CHLORIDE	15MEQ	FOR SOLUTION / ORAL		RLD	2025-11-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N208019-001	AA

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N208019-001	POTASSIUM CHLORIDE	20MEQ	FOR SOLUTION / ORAL	AA	RLD	2015-08-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208019-002	POKONZA	10MEQ	FOR SOLUTION / ORAL		RLD	2023-08-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208019-003	POTASSIUM CHLORIDE	40MEQ	FOR SOLUTION / ORAL		RLD	2023-08-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208019-004	POKONZA	15MEQ	FOR SOLUTION / ORAL		RLD	2025-11-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208019-001	POTASSIUM CHLORIDE	20MEQ	FOR SOLUTION / ORAL	AA	RLD	2015-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208019-002	POKONZA	10MEQ	FOR SOLUTION / ORAL		RLD	2023-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208019-003	POTASSIUM CHLORIDE	40MEQ	FOR SOLUTION / ORAL		RLD, RS	2023-08-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208019-001	POTASSIUM CHLORIDE	20MEQ	FOR SOLUTION / ORAL	AA	RLD	2015-08-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208019-002	POKONZA	10MEQ	FOR SOLUTION / ORAL		RLD	2023-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208019-003	POTASSIUM CHLORIDE	40MEQ	FOR SOLUTION / ORAL		RLD, RS	2023-08-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208019-001	POTASSIUM CHLORIDE	20MEQ	FOR SOLUTION / ORAL	AA	RLD, RS	2015-08-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208019-002	POKONZA	10MEQ	FOR SOLUTION / ORAL		RLD	2023-08-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208019-003	POTASSIUM CHLORIDE	40MEQ	FOR SOLUTION / ORAL		RLD	2023-08-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208019-001	POTASSIUM CHLORIDE	20MEQ	FOR SOLUTION / ORAL	AA	RLD, RS	2015-08-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208019-002	POKONZA	10MEQ	FOR SOLUTION / ORAL		RLD	2023-08-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208019-003	POTASSIUM CHLORIDE	40MEQ	FOR SOLUTION / ORAL		RLD	2023-08-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208019-001	POTASSIUM CHLORIDE	20MEQ	FOR SOLUTION / ORAL	AA	RLD, RS	2015-08-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208019-002	POKONZA	10MEQ	FOR SOLUTION / ORAL		RLD	2023-08-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208019-003	POTASSIUM CHLORIDE	40MEQ	FOR SOLUTION / ORAL		RLD	2023-08-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208019-001	POTASSIUM CHLORIDE	20MEQ	FOR SOLUTION / ORAL	AA	RLD	2015-08-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208019-002	POKONZA	10MEQ	FOR SOLUTION / ORAL		RLD	2023-08-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208019-003	POTASSIUM CHLORIDE	40MEQ	FOR SOLUTION / ORAL		RLD, RS	2023-08-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208019-001	POTASSIUM CHLORIDE	20MEQ	FOR SOLUTION / ORAL	AA	RLD	2015-08-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208019-002	POKONZA	10MEQ	FOR SOLUTION / ORAL		RLD	2023-08-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208019-003	POTASSIUM CHLORIDE	40MEQ	FOR SOLUTION / ORAL		RLD, RS	2023-08-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208019-001	POTASSIUM CHLORIDE	20MEQ	FOR SOLUTION / ORAL	AA	RLD	2015-08-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208019-002	POKONZA	10MEQ	FOR SOLUTION / ORAL		RLD	2023-08-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208019-003	POTASSIUM CHLORIDE	40MEQ	FOR SOLUTION / ORAL		RLD, RS	2023-08-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208019-001	POTASSIUM CHLORIDE	20MEQ	FOR SOLUTION / ORAL	AA	RLD	2015-08-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208019-002	POKONZA	10MEQ	FOR SOLUTION / ORAL		RLD	2023-08-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208019-003	POTASSIUM CHLORIDE	40MEQ	FOR SOLUTION / ORAL		RLD, RS	2023-08-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208019-001	POTASSIUM CHLORIDE	20MEQ	FOR SOLUTION / ORAL	AA	RLD	2015-08-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208019-002	POKONZA	10MEQ	FOR SOLUTION / ORAL		RLD	2023-08-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208019-003	POTASSIUM CHLORIDE	40MEQ	FOR SOLUTION / ORAL		RLD, RS	2023-08-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208019-001	POTASSIUM CHLORIDE	20MEQ	FOR SOLUTION / ORAL	AA	RLD	2015-08-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208019-002	POKONZA	10MEQ	FOR SOLUTION / ORAL		RLD	2023-08-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208019-003	POTASSIUM CHLORIDE	40MEQ	FOR SOLUTION / ORAL		RLD, RS	2023-08-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208019-001	POTASSIUM CHLORIDE	20MEQ	FOR SOLUTION / ORAL	AA	RLD	2015-08-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208019-002	POKONZA	10MEQ	FOR SOLUTION / ORAL		RLD	2023-08-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208019-003	POTASSIUM CHLORIDE	40MEQ	FOR SOLUTION / ORAL		RLD, RS	2023-08-25	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	N208019-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208019-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208019-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208019-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208019-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208019-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208019-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208019-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208019-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208019-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208019-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208019-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208019-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208019-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208019-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208019-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208019-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208019-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208019-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208019-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208019-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208019-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208019-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208019-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208019-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208019-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208019-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208019-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208019-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208019-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208019-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208019-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208019-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208019-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208019-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208019-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208019-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208019-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208019-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208019-001	AA	1	`e64feba35796…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
POKONZA	POTASSIUM CHLORIDE	Carwin Pharmaceutical Associates, LLC	0700c19e-abca-4527-8944-e4440a32e3af	2025-12-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208019 application number: NDA208019
Potassium Chloride	POTASSIUM CHLORIDE	IPG Pharmaceuticals, Inc.	5dad0879-0f97-4c7d-98fa-baaed51cd2d8	2025-12-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208019 application number: NDA208019
Potassium Chloride	POTASSIUM CHLORIDE	Endo USA, Inc.	a64d7151-09a6-474c-83fc-36c7cf582d32	2025-03-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208019 application number: NDA208019 ndc (product): 0603-1554
POKONZA	POTASSIUM CHLORIDE	Carwin Pharmaceutical Associates, LLC	7c5cc705-e5da-4487-86c9-9d545a95afb4	2024-03-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208019 application number: NDA208019
Potassium Chloride	POTASSIUM CHLORIDE	Genus Lifesciences Inc.	23d818e7-c076-40de-8dc1-0b51ba4be96a	2020-04-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208019 application number: NDA208019 ndc (product): 64950-321

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0603-1554	Potassium Chloride	Potassium Chloride	Par Pharmaceutical	NDA	Current
0603-1554	Potassium Chloride	Potassium Chloride	Par Pharmaceutical	NDA	Current
0603-1554	Potassium Chloride	Potassium Chloride	Par Pharmaceutical	NDA	Current
64950-321	Potassium Chloride	Potassium Chloride	Genus Lifesciences Inc.	NDA	Current
64950-321	Potassium Chloride	Potassium Chloride	Genus Lifesciences Inc.	NDA	Current
69543-379	Potassium Chloride for Oral Solution	Potassium Chloride	Virtus Pharmaceuticals	NDA	Current
69543-379	Potassium Chloride for Oral Solution	Potassium Chloride	Virtus Pharmaceuticals	NDA	Current
69543-379	Potassium Chloride for Oral Solution	Potassium Chloride	Virtus Pharmaceuticals	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
62070	SUPPL	2020-03-06
62055	SUPPL	2020-03-06
59317	SUPPL	2020-01-03
59308	SUPPL	2019-07-11
44970	ORIG	2016-05-04
23047	ORIG	2016-05-04
10640	ORIG	2015-08-21
40611	ORIG	2015-08-20