Application 213523

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 IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;74.5MG/100ML;450MG/100ML	No	No
002	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;149MG/100ML;450MG/100ML	No	No
003	POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;224MG/100ML;450MG/100ML	No	No
004	POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;298MG/100ML;450MG/100ML	No	No
005	POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	INJECTABLE;INJECTION	5GM/100ML;149MG/100ML;450MG/100ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A213523-001	POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	5GM/100ML;74.5MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09
A213523-002	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	5GM/100ML;149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09
A213523-003	POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	5GM/100ML;224MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09
A213523-004	POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	5GM/100ML;298MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09
A213523-005	POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	5GM/100ML;149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2022-10-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213523-001	AP
A213523-002	AP
A213523-003	AP
A213523-004	AP
A213523-005	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 · 162 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
2026-02-19 14:30 UTC	2026-02	A213523-001	POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;74.5MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213523-002	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213523-003	POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;224MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213523-004	POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;298MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213523-005	POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2022-10-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213523-001	POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;74.5MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213523-002	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213523-003	POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;224MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213523-004	POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;298MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213523-005	POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2022-10-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213523-001	POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;74.5MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213523-002	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213523-003	POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;224MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213523-004	POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;298MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213523-005	POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2022-10-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213523-001	POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;74.5MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213523-002	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213523-003	POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;224MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213523-004	POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;298MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213523-005	POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2022-10-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213523-001	POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;74.5MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213523-002	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213523-003	POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;224MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213523-004	POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;298MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213523-005	POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2022-10-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213523-001	POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;74.5MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213523-002	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213523-003	POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;224MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213523-004	POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;298MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213523-005	POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2022-10-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213523-001	POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;74.5MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213523-002	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213523-003	POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;224MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213523-004	POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;298MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213523-005	POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2022-10-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213523-001	POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;74.5MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213523-002	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213523-003	POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;224MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213523-004	POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;298MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2021-03-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213523-005	POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%	5GM/100ML;149MG/100ML;450MG/100ML	INJECTABLE / INJECTION	AP	2022-10-11	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 122 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A213523-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213523-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213523-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213523-004	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213523-005	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213523-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213523-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213523-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213523-004	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213523-005	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213523-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213523-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213523-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213523-004	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213523-005	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213523-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213523-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213523-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213523-004	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213523-005	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213523-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213523-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213523-003	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213523-004	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213523-005	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213523-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213523-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213523-003	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213523-004	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213523-005	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213523-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213523-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213523-003	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213523-004	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213523-005	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213523-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213523-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213523-003	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213523-004	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213523-005	AP	1	`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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Potassium Chloride in Dextrose and Sodium Chloride	DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, AND POTASSIUM CHLORIDE	Fresenius Kabi USA, LLC	fe5b5182-c859-4c74-b2e0-467be5b2e329	2024-05-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213523 application number: ANDA213523 ndc (product): 65219-144 ndc (product): 65219-146 ndc (product): 65219-148 ndc (product): 65219-142 ndc (product): 65219-150

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
65219-142	Potassium Chloride in Dextrose and Sodium Chloride	DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
65219-142	Potassium Chloride in Dextrose and Sodium Chloride	DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
65219-144	Potassium Chloride in Dextrose and Sodium Chloride	DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
65219-144	Potassium Chloride in Dextrose and Sodium Chloride	DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
65219-146	Potassium Chloride in Dextrose and Sodium Chloride	DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
65219-146	Potassium Chloride in Dextrose and Sodium Chloride	DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
65219-148	Potassium Chloride in Dextrose and Sodium Chloride	DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
65219-148	Potassium Chloride in Dextrose and Sodium Chloride	DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
65219-150	Potassium Chloride in Dextrose and Sodium Chloride	DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
65219-150	Potassium Chloride in Dextrose and Sodium Chloride	DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
67045	ORIG	2021-04-13