Application 214727

Type: ANDA
Sponsor: NEXUS PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	POTASSIUM CHLORIDE 10MEQ	POTASSIUM CHLORIDE	INJECTABLE;INJECTION	14.9MG/ML	No	No
002	POTASSIUM CHLORIDE 10MEQ	POTASSIUM CHLORIDE	INJECTABLE;INJECTION	745MG/100ML	No	No
003	POTASSIUM CHLORIDE 20MEQ	POTASSIUM CHLORIDE	INJECTABLE;INJECTION	29.8MG/ML	No	No
004	POTASSIUM CHLORIDE 20MEQ	POTASSIUM CHLORIDE	INJECTABLE;INJECTION	1.49GM/100ML	No	No
005	POTASSIUM CHLORIDE 40MEQ	POTASSIUM CHLORIDE	INJECTABLE;INJECTION	2.98GM/100ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A214727-001	POTASSIUM CHLORIDE 10MEQ	POTASSIUM CHLORIDE	14.9MG/ML	INJECTABLE / INJECTION	AP	2021-03-18
A214727-002	POTASSIUM CHLORIDE 10MEQ	POTASSIUM CHLORIDE	745MG/100ML	INJECTABLE / INJECTION	AP	2021-03-18
A214727-003	POTASSIUM CHLORIDE 20MEQ	POTASSIUM CHLORIDE	29.8MG/ML	INJECTABLE / INJECTION	AP	2021-03-18
A214727-004	POTASSIUM CHLORIDE 20MEQ	POTASSIUM CHLORIDE	1.49GM/100ML	INJECTABLE / INJECTION	AP	2021-03-18
A214727-005	POTASSIUM CHLORIDE 40MEQ	POTASSIUM CHLORIDE	2.98GM/100ML	INJECTABLE / INJECTION	AP	2021-03-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A214727-001	AP
A214727-002	AP
A214727-003	AP
A214727-004	AP
A214727-005	AP

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 5 · 180 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	A214727-001	POTASSIUM CHLORIDE 10MEQ	14.9MG/ML	INJECTABLE / INJECTION	AP	2021-03-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214727-002	POTASSIUM CHLORIDE 10MEQ	745MG/100ML	INJECTABLE / INJECTION	AP	2021-03-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214727-003	POTASSIUM CHLORIDE 20MEQ	29.8MG/ML	INJECTABLE / INJECTION	AP	2021-03-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214727-004	POTASSIUM CHLORIDE 20MEQ	1.49GM/100ML	INJECTABLE / INJECTION	AP	2021-03-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214727-005	POTASSIUM CHLORIDE 40MEQ	2.98GM/100ML	INJECTABLE / INJECTION	AP	2021-03-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214727-001	POTASSIUM CHLORIDE 10MEQ	14.9MG/ML	INJECTABLE / INJECTION	AP	2021-03-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214727-002	POTASSIUM CHLORIDE 10MEQ	745MG/100ML	INJECTABLE / INJECTION	AP	2021-03-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214727-003	POTASSIUM CHLORIDE 20MEQ	29.8MG/ML	INJECTABLE / INJECTION	AP	2021-03-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214727-004	POTASSIUM CHLORIDE 20MEQ	1.49GM/100ML	INJECTABLE / INJECTION	AP	2021-03-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214727-005	POTASSIUM CHLORIDE 40MEQ	2.98GM/100ML	INJECTABLE / INJECTION	AP	2021-03-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214727-001	POTASSIUM CHLORIDE 10MEQ	14.9MG/ML	INJECTABLE / INJECTION	AP	2021-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214727-002	POTASSIUM CHLORIDE 10MEQ	745MG/100ML	INJECTABLE / INJECTION	AP	2021-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214727-003	POTASSIUM CHLORIDE 20MEQ	29.8MG/ML	INJECTABLE / INJECTION	AP	2021-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214727-004	POTASSIUM CHLORIDE 20MEQ	1.49GM/100ML	INJECTABLE / INJECTION	AP	2021-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214727-005	POTASSIUM CHLORIDE 40MEQ	2.98GM/100ML	INJECTABLE / INJECTION	AP	2021-03-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214727-001	POTASSIUM CHLORIDE 10MEQ	14.9MG/ML	INJECTABLE / INJECTION	AP	2021-03-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214727-002	POTASSIUM CHLORIDE 10MEQ	745MG/100ML	INJECTABLE / INJECTION	AP	2021-03-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214727-003	POTASSIUM CHLORIDE 20MEQ	29.8MG/ML	INJECTABLE / INJECTION	AP	2021-03-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214727-004	POTASSIUM CHLORIDE 20MEQ	1.49GM/100ML	INJECTABLE / INJECTION	AP	2021-03-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214727-005	POTASSIUM CHLORIDE 40MEQ	2.98GM/100ML	INJECTABLE / INJECTION	AP	2021-03-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214727-001	POTASSIUM CHLORIDE 10MEQ	14.9MG/ML	INJECTABLE / INJECTION	AP	2021-03-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214727-002	POTASSIUM CHLORIDE 10MEQ	745MG/100ML	INJECTABLE / INJECTION	AP	2021-03-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214727-003	POTASSIUM CHLORIDE 20MEQ	29.8MG/ML	INJECTABLE / INJECTION	AP	2021-03-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214727-004	POTASSIUM CHLORIDE 20MEQ	1.49GM/100ML	INJECTABLE / INJECTION	AP	2021-03-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214727-005	POTASSIUM CHLORIDE 40MEQ	2.98GM/100ML	INJECTABLE / INJECTION	AP	2021-03-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214727-001	POTASSIUM CHLORIDE 10MEQ	14.9MG/ML	INJECTABLE / INJECTION	AP	2021-03-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214727-002	POTASSIUM CHLORIDE 10MEQ	745MG/100ML	INJECTABLE / INJECTION	AP	2021-03-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214727-003	POTASSIUM CHLORIDE 20MEQ	29.8MG/ML	INJECTABLE / INJECTION	AP	2021-03-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214727-004	POTASSIUM CHLORIDE 20MEQ	1.49GM/100ML	INJECTABLE / INJECTION	AP	2021-03-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214727-005	POTASSIUM CHLORIDE 40MEQ	2.98GM/100ML	INJECTABLE / INJECTION	AP	2021-03-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214727-001	POTASSIUM CHLORIDE 10MEQ	14.9MG/ML	INJECTABLE / INJECTION	AP	2021-03-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214727-002	POTASSIUM CHLORIDE 10MEQ	745MG/100ML	INJECTABLE / INJECTION	AP	2021-03-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214727-003	POTASSIUM CHLORIDE 20MEQ	29.8MG/ML	INJECTABLE / INJECTION	AP	2021-03-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214727-004	POTASSIUM CHLORIDE 20MEQ	1.49GM/100ML	INJECTABLE / INJECTION	AP	2021-03-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214727-005	POTASSIUM CHLORIDE 40MEQ	2.98GM/100ML	INJECTABLE / INJECTION	AP	2021-03-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214727-001	POTASSIUM CHLORIDE 10MEQ	14.9MG/ML	INJECTABLE / INJECTION	AP	2021-03-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214727-002	POTASSIUM CHLORIDE 10MEQ	745MG/100ML	INJECTABLE / INJECTION	AP	2021-03-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214727-003	POTASSIUM CHLORIDE 20MEQ	29.8MG/ML	INJECTABLE / INJECTION	AP	2021-03-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214727-004	POTASSIUM CHLORIDE 20MEQ	1.49GM/100ML	INJECTABLE / INJECTION	AP	2021-03-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214727-005	POTASSIUM CHLORIDE 40MEQ	2.98GM/100ML	INJECTABLE / INJECTION	AP	2021-03-18	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 5 · 180 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214727-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214727-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214727-003	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214727-004	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214727-005	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214727-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214727-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214727-003	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214727-004	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214727-005	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214727-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214727-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214727-003	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214727-004	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214727-005	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214727-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214727-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214727-003	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214727-004	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214727-005	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214727-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214727-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214727-003	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214727-004	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214727-005	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214727-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214727-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214727-003	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214727-004	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214727-005	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214727-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214727-002	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214727-003	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214727-004	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214727-005	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214727-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214727-002	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214727-003	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214727-004	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214727-005	AP	1	`8072bd15b7f6…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Potassium Chloride	POTASSIUM CHLORIDE	Nexus Pharamaceuticals Inc.	765ef38c-df36-46d1-9062-61e30ff46a86	2023-06-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214727 application number: ANDA214727 ndc (product): 14789-107 ndc (product): 14789-108 ndc (product): 14789-109

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
14789-107	Potassium Chloride	Potassium Chloride	Nexus Pharamaceuticals Inc.	ANDA	Current
14789-108	Potassium Chloride	Potassium Chloride	Nexus Pharamaceuticals Inc.	ANDA	Current
14789-109	Potassium Chloride	Potassium Chloride	Nexus Pharamaceuticals Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
67046	ORIG	2021-04-13