Application 211087

Type: ANDA
Sponsor: FRESENIUS KABI USA

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	746MG/100ML	No	No
003	POTASSIUM CHLORIDE 20MEQ	POTASSIUM CHLORIDE	INJECTABLE;INJECTION	29.8MG/ML	No	No
004	POTASSIUM CHLORIDE 40MEQ	POTASSIUM CHLORIDE	INJECTABLE;INJECTION	2.98GM/100ML	No	No
005	POTASSIUM CHLORIDE 20MEQ	POTASSIUM CHLORIDE	INJECTABLE;INJECTION	1.49GM/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
A211087-001	POTASSIUM CHLORIDE 10MEQ	POTASSIUM CHLORIDE	14.9MG/ML	INJECTABLE / INJECTION	AP	2020-09-09
A211087-002	POTASSIUM CHLORIDE 10MEQ	POTASSIUM CHLORIDE	746MG/100ML	INJECTABLE / INJECTION	AP	2020-09-09
A211087-003	POTASSIUM CHLORIDE 20MEQ	POTASSIUM CHLORIDE	29.8MG/ML	INJECTABLE / INJECTION	AP	2020-09-09
A211087-004	POTASSIUM CHLORIDE 40MEQ	POTASSIUM CHLORIDE	2.98GM/100ML	INJECTABLE / INJECTION	AP	2020-09-09
A211087-005	POTASSIUM CHLORIDE 20MEQ	POTASSIUM CHLORIDE	1.49GM/100ML	INJECTABLE / INJECTION	AP	2021-05-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211087-001	AP
A211087-002	AP
A211087-003	AP
A211087-004	AP
A211087-005	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 · 191 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	A211087-001	POTASSIUM CHLORIDE 10MEQ	14.9MG/ML	INJECTABLE / INJECTION	AP	2020-09-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211087-002	POTASSIUM CHLORIDE 10MEQ	746MG/100ML	INJECTABLE / INJECTION	AP	2020-09-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211087-003	POTASSIUM CHLORIDE 20MEQ	29.8MG/ML	INJECTABLE / INJECTION	AP	2020-09-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211087-004	POTASSIUM CHLORIDE 40MEQ	2.98GM/100ML	INJECTABLE / INJECTION	AP	2020-09-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211087-005	POTASSIUM CHLORIDE 20MEQ	1.49GM/100ML	INJECTABLE / INJECTION	AP	2021-05-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211087-001	POTASSIUM CHLORIDE 10MEQ	14.9MG/ML	INJECTABLE / INJECTION	AP	2020-09-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211087-002	POTASSIUM CHLORIDE 10MEQ	746MG/100ML	INJECTABLE / INJECTION	AP	2020-09-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211087-003	POTASSIUM CHLORIDE 20MEQ	29.8MG/ML	INJECTABLE / INJECTION	AP	2020-09-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211087-004	POTASSIUM CHLORIDE 40MEQ	2.98GM/100ML	INJECTABLE / INJECTION	AP	2020-09-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211087-005	POTASSIUM CHLORIDE 20MEQ	1.49GM/100ML	INJECTABLE / INJECTION	AP	2021-05-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211087-001	POTASSIUM CHLORIDE 10MEQ	14.9MG/ML	INJECTABLE / INJECTION	AP	2020-09-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211087-002	POTASSIUM CHLORIDE 10MEQ	746MG/100ML	INJECTABLE / INJECTION	AP	2020-09-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211087-003	POTASSIUM CHLORIDE 20MEQ	29.8MG/ML	INJECTABLE / INJECTION	AP	2020-09-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211087-004	POTASSIUM CHLORIDE 40MEQ	2.98GM/100ML	INJECTABLE / INJECTION	AP	2020-09-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211087-005	POTASSIUM CHLORIDE 20MEQ	1.49GM/100ML	INJECTABLE / INJECTION	AP	2021-05-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211087-001	POTASSIUM CHLORIDE 10MEQ	14.9MG/ML	INJECTABLE / INJECTION	AP	2020-09-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211087-002	POTASSIUM CHLORIDE 10MEQ	746MG/100ML	INJECTABLE / INJECTION	AP	2020-09-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211087-003	POTASSIUM CHLORIDE 20MEQ	29.8MG/ML	INJECTABLE / INJECTION	AP	2020-09-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211087-004	POTASSIUM CHLORIDE 40MEQ	2.98GM/100ML	INJECTABLE / INJECTION	AP	2020-09-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211087-005	POTASSIUM CHLORIDE 20MEQ	1.49GM/100ML	INJECTABLE / INJECTION	AP	2021-05-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211087-001	POTASSIUM CHLORIDE 10MEQ	14.9MG/ML	INJECTABLE / INJECTION	AP	2020-09-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211087-002	POTASSIUM CHLORIDE 10MEQ	746MG/100ML	INJECTABLE / INJECTION	AP	2020-09-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211087-003	POTASSIUM CHLORIDE 20MEQ	29.8MG/ML	INJECTABLE / INJECTION	AP	2020-09-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211087-004	POTASSIUM CHLORIDE 40MEQ	2.98GM/100ML	INJECTABLE / INJECTION	AP	2020-09-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211087-005	POTASSIUM CHLORIDE 20MEQ	1.49GM/100ML	INJECTABLE / INJECTION	AP	2021-05-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211087-001	POTASSIUM CHLORIDE 10MEQ	14.9MG/ML	INJECTABLE / INJECTION	AP	2020-09-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211087-002	POTASSIUM CHLORIDE 10MEQ	746MG/100ML	INJECTABLE / INJECTION	AP	2020-09-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211087-003	POTASSIUM CHLORIDE 20MEQ	29.8MG/ML	INJECTABLE / INJECTION	AP	2020-09-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211087-004	POTASSIUM CHLORIDE 40MEQ	2.98GM/100ML	INJECTABLE / INJECTION	AP	2020-09-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211087-005	POTASSIUM CHLORIDE 20MEQ	1.49GM/100ML	INJECTABLE / INJECTION	AP	2021-05-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211087-001	POTASSIUM CHLORIDE 10MEQ	14.9MG/ML	INJECTABLE / INJECTION	AP	2020-09-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211087-002	POTASSIUM CHLORIDE 10MEQ	746MG/100ML	INJECTABLE / INJECTION	AP	2020-09-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211087-003	POTASSIUM CHLORIDE 20MEQ	29.8MG/ML	INJECTABLE / INJECTION	AP	2020-09-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211087-004	POTASSIUM CHLORIDE 40MEQ	2.98GM/100ML	INJECTABLE / INJECTION	AP	2020-09-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211087-005	POTASSIUM CHLORIDE 20MEQ	1.49GM/100ML	INJECTABLE / INJECTION	AP	2021-05-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211087-001	POTASSIUM CHLORIDE 10MEQ	14.9MG/ML	INJECTABLE / INJECTION	AP	2020-09-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211087-002	POTASSIUM CHLORIDE 10MEQ	746MG/100ML	INJECTABLE / INJECTION	AP	2020-09-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211087-003	POTASSIUM CHLORIDE 20MEQ	29.8MG/ML	INJECTABLE / INJECTION	AP	2020-09-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211087-004	POTASSIUM CHLORIDE 40MEQ	2.98GM/100ML	INJECTABLE / INJECTION	AP	2020-09-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211087-005	POTASSIUM CHLORIDE 20MEQ	1.49GM/100ML	INJECTABLE / INJECTION	AP	2021-05-07	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A211087-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211087-002	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211087-003	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211087-004	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211087-005	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211087-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211087-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211087-003	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211087-004	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211087-005	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211087-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211087-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211087-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211087-004	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211087-005	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211087-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211087-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211087-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211087-004	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211087-005	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211087-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211087-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211087-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211087-004	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211087-005	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211087-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211087-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211087-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211087-004	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211087-005	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211087-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211087-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211087-003	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211087-004	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211087-005	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211087-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211087-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211087-003	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211087-004	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211087-005	AP	1	`03ed91905a0d…`

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	Fresenius Kabi USA, LLC	3849b89c-c309-46fb-a1e2-53ff0c65077f	2024-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211087 application number: ANDA211087 ndc (product): 65219-010 ndc (product): 65219-008 ndc (product): 65219-012 ndc (product): 65219-004 ndc (product): 65219-006

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 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
65219-004	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
65219-004	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
65219-006	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
65219-006	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
65219-008	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
65219-008	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
65219-010	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
65219-010	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
65219-012	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
65219-012	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
65096	ORIG	2020-10-30