Application 080195

Type: ANDA
Sponsor: MILES

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	INJECTABLE;INJECTION	2MEQ/ML	No	No
002	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	INJECTABLE;INJECTION	1MEQ/ML	No	No
003	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	INJECTABLE;INJECTION	3MEQ/ML	No	No
004	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	INJECTABLE;INJECTION	4MEQ/ML	No	No

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

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	RLD / RS
A080195-001	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	2MEQ/ML	INJECTABLE / INJECTION	Approved before 1982
A080195-002	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	1MEQ/ML	INJECTABLE / INJECTION	Approved before 1982
A080195-003	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	3MEQ/ML	INJECTABLE / INJECTION	Approved before 1982
A080195-004	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	4MEQ/ML	INJECTABLE / INJECTION	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 5 · 172 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	A080195-001	POTASSIUM CHLORIDE	2MEQ/ML	INJECTABLE / INJECTION	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A080195-002	POTASSIUM CHLORIDE	1MEQ/ML	INJECTABLE / INJECTION	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A080195-003	POTASSIUM CHLORIDE	3MEQ/ML	INJECTABLE / INJECTION	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A080195-004	POTASSIUM CHLORIDE	4MEQ/ML	INJECTABLE / INJECTION	Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A080195-001	POTASSIUM CHLORIDE	2MEQ/ML	INJECTABLE / INJECTION	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A080195-002	POTASSIUM CHLORIDE	1MEQ/ML	INJECTABLE / INJECTION	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A080195-003	POTASSIUM CHLORIDE	3MEQ/ML	INJECTABLE / INJECTION	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A080195-004	POTASSIUM CHLORIDE	4MEQ/ML	INJECTABLE / INJECTION	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A080195-001	POTASSIUM CHLORIDE	2MEQ/ML	INJECTABLE / INJECTION	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A080195-002	POTASSIUM CHLORIDE	1MEQ/ML	INJECTABLE / INJECTION	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A080195-003	POTASSIUM CHLORIDE	3MEQ/ML	INJECTABLE / INJECTION	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A080195-004	POTASSIUM CHLORIDE	4MEQ/ML	INJECTABLE / INJECTION	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080195-001	POTASSIUM CHLORIDE	2MEQ/ML	INJECTABLE / INJECTION	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080195-002	POTASSIUM CHLORIDE	1MEQ/ML	INJECTABLE / INJECTION	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080195-003	POTASSIUM CHLORIDE	3MEQ/ML	INJECTABLE / INJECTION	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080195-004	POTASSIUM CHLORIDE	4MEQ/ML	INJECTABLE / INJECTION	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A080195-001	POTASSIUM CHLORIDE	2MEQ/ML	INJECTABLE / INJECTION	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A080195-002	POTASSIUM CHLORIDE	1MEQ/ML	INJECTABLE / INJECTION	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A080195-003	POTASSIUM CHLORIDE	3MEQ/ML	INJECTABLE / INJECTION	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A080195-004	POTASSIUM CHLORIDE	4MEQ/ML	INJECTABLE / INJECTION	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080195-001	POTASSIUM CHLORIDE	2MEQ/ML	INJECTABLE / INJECTION	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080195-002	POTASSIUM CHLORIDE	1MEQ/ML	INJECTABLE / INJECTION	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080195-003	POTASSIUM CHLORIDE	3MEQ/ML	INJECTABLE / INJECTION	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080195-004	POTASSIUM CHLORIDE	4MEQ/ML	INJECTABLE / INJECTION	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080195-001	POTASSIUM CHLORIDE	2MEQ/ML	INJECTABLE / INJECTION	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080195-002	POTASSIUM CHLORIDE	1MEQ/ML	INJECTABLE / INJECTION	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080195-003	POTASSIUM CHLORIDE	3MEQ/ML	INJECTABLE / INJECTION	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080195-004	POTASSIUM CHLORIDE	4MEQ/ML	INJECTABLE / INJECTION	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080195-001	POTASSIUM CHLORIDE	2MEQ/ML	INJECTABLE / INJECTION	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080195-002	POTASSIUM CHLORIDE	1MEQ/ML	INJECTABLE / INJECTION	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080195-003	POTASSIUM CHLORIDE	3MEQ/ML	INJECTABLE / INJECTION	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080195-004	POTASSIUM CHLORIDE	4MEQ/ML	INJECTABLE / INJECTION	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080195-001	POTASSIUM CHLORIDE	2MEQ/ML	INJECTABLE / INJECTION	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080195-002	POTASSIUM CHLORIDE	1MEQ/ML	INJECTABLE / INJECTION	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080195-003	POTASSIUM CHLORIDE	3MEQ/ML	INJECTABLE / INJECTION	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080195-004	POTASSIUM CHLORIDE	4MEQ/ML	INJECTABLE / INJECTION	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080195-001	POTASSIUM CHLORIDE	2MEQ/ML	INJECTABLE / INJECTION	Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080195-002	POTASSIUM CHLORIDE	1MEQ/ML	INJECTABLE / INJECTION	Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080195-003	POTASSIUM CHLORIDE	3MEQ/ML	INJECTABLE / INJECTION	Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080195-004	POTASSIUM CHLORIDE	4MEQ/ML	INJECTABLE / INJECTION	Approved before 1982	`5bbf6a4d5a75…`

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 9 of 10 · 200 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Kali muriaticum	POTASSIUM CHLORIDE	Boiron	8608a8de-8133-1d4b-e053-2991aa0a907a	2023-11-13		Name fallback generic name: POTASSIUM CHLORIDE
Kali muriaticum	POTASSIUM CHLORIDE	Boiron	860887e7-7eaf-78c2-e053-2991aa0a9a75	2023-11-13		Name fallback generic name: POTASSIUM CHLORIDE
Kali muriaticum	POTASSIUM CHLORIDE	Boiron	86086aab-c411-7cf2-e053-2991aa0a81bd	2023-11-13		Name fallback generic name: POTASSIUM CHLORIDE
Kali muriaticum	POTASSIUM CHLORIDE	Boiron	8608a379-c3b7-3053-e053-2a91aa0a2e65	2023-11-13		Name fallback generic name: POTASSIUM CHLORIDE
Kali muriaticum	POTASSIUM CHLORIDE	Boiron	8608f3dd-31bf-0182-e053-2991aa0a1030	2023-11-13		Name fallback generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Lupin Pharmaceuticals, Inc.	1f33bcfe-c28a-4800-9241-685d974a5d91	2023-11-08	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
Kali muriaticum	POTASSIUM CHLORIDE	Boiron	caaad470-7be1-11e6-b409-424c58303031	2023-10-16		Name fallback generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	A-S Medication Solutions	e1670127-c551-441b-bac4-39f10a6d156f	2023-09-18	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	A-S Medication Solutions	f1af7e05-68ba-438e-a63b-cd8c23960c85	2023-09-06	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
Potassium Chloride Extended-Release	POTASSIUM CHLORIDE	A-S Medication Solutions	0dc6c066-1a59-4798-b9e6-d66872245389	2023-09-04	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CHLORIDE
Kali muriaticum	POTASSIUM CHLORIDE	Boiron	86099779-8dbd-a9eb-e053-2991aa0ab7a7	2023-07-20		Name fallback generic name: POTASSIUM CHLORIDE
Potassium chloride	POTASSIUM CHLORIDE	ANI Pharmaceuticals, Inc.	0128a879-7185-4b70-b0bb-d108ff1c9542	2023-07-20	Warnings, Adverse reactions	Name fallback brand name: Potassium chloride generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Nexus Pharamaceuticals Inc.	765ef38c-df36-46d1-9062-61e30ff46a86	2023-06-13	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Fresenius Kabi USA, LLC	fcd4f458-ce27-417e-9bb6-de1cc49d44b9	2023-02-27	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	A-S Medication Solutions	87cc7349-5a07-4a39-be97-4e1013814f30	2023-02-06	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
POTASSIUM CHLORIDE EXTENDED RELEASE	POTASSIUM CHLORIDE	Granules Pharmaceuticals Inc.	9f8d2886-9ecd-4cbf-a84a-2d221cb3497c	2023-01-27	Warnings, Adverse reactions	Name fallback generic name: POTASSIUM CHLORIDE
Kali muriaticum	POTASSIUM CHLORIDE	Boiron	8608d5a3-93e6-e8e2-e053-2a91aa0aaedc	2023-01-23		Name fallback generic name: POTASSIUM CHLORIDE
KALI MURIATICUM	POTASSIUM CHLORIDE	Hyland's Inc.	2e8a4762-d28d-4b64-892f-913e04d18d2d	2022-12-19	Warnings	Name fallback generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Zydus Pharmaceuticals (USA) Inc.	31e02249-7984-4b8f-9e37-2b79b708ac08	2022-10-18	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE
Potassium Chloride	POTASSIUM CHLORIDE	Zydus Lifesciences Limited	099c3a36-f460-4191-80e5-0c4153a5c713	2022-10-18	Warnings, Adverse reactions	Name fallback brand name: Potassium Chloride generic name: POTASSIUM CHLORIDE

Reported adverse events (FAERS/openFDA)#

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