Application 215371

Type: ANDA
Sponsor: FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	KABILYTE	MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE	INJECTABLE;INJECTION	30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A215371-001	MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 7.4	MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE	30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML	INJECTABLE / INJECTION	AP		2022-06-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215371-001	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.

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	A215371-001	MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 7.4	30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML	INJECTABLE / INJECTION	AP	2022-06-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215371-001	MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 7.4	30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML	INJECTABLE / INJECTION	AP	2022-06-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215371-001	MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 7.4	30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML	INJECTABLE / INJECTION	AP	2022-06-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215371-001	MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 7.4	30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML	INJECTABLE / INJECTION	AP	2022-06-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215371-001	MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 7.4	30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML	INJECTABLE / INJECTION	AP	2022-06-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215371-001	MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 7.4	30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML	INJECTABLE / INJECTION	AP	2022-06-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215371-001	MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 7.4	30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML	INJECTABLE / INJECTION	AP	2022-06-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215371-001	MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 7.4	30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML	INJECTABLE / INJECTION	AP	2022-06-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215371-001	MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 7.4	30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML	INJECTABLE / INJECTION	AP	2022-06-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215371-001	MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 7.4	30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML	INJECTABLE / INJECTION	AP	2022-06-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215371-001	MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 7.4	30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML	INJECTABLE / INJECTION	AP	2022-06-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215371-001	MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 7.4	30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML	INJECTABLE / INJECTION	AP	2022-06-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215371-001	MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 7.4	30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML	INJECTABLE / INJECTION	AP	2022-06-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215371-001	MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 7.4	30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML	INJECTABLE / INJECTION	AP	2022-06-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215371-001	KABILYTE	30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML	INJECTABLE / INJECTION	AP	2022-06-08	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215371-001	MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 7.4	30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML	INJECTABLE / INJECTION	AP	2022-06-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215371-001	MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 7.4	30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML	INJECTABLE / INJECTION	AP	2022-06-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215371-001	MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 7.4	30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML	INJECTABLE / INJECTION	AP	2022-06-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215371-001	MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 7.4	30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML	INJECTABLE / INJECTION	AP	2022-06-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215371-001	MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 7.4	30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML	INJECTABLE / INJECTION	AP	2022-06-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215371-001	MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 7.4	30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML	INJECTABLE / INJECTION	AP	2022-06-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215371-001	MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 7.4	30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML	INJECTABLE / INJECTION	AP	2022-06-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215371-001	MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 7.4	30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML	INJECTABLE / INJECTION	AP	2022-06-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215371-001	MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 7.4	30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML	INJECTABLE / INJECTION		2022-06-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215371-001	MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 7.4	30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML	INJECTABLE / INJECTION	AP	2022-06-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215371-001	MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 7.4	30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML	INJECTABLE / INJECTION	AP	2022-06-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215371-001	MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 7.4	30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML	INJECTABLE / INJECTION	AP	2022-06-08	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A215371-001	MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 7.4	30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML	INJECTABLE / INJECTION	AP	2022-06-08	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215371-001	MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 7.4	30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML	INJECTABLE / INJECTION	AP	2022-06-08	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A215371-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215371-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215371-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215371-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215371-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215371-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215371-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215371-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215371-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215371-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215371-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215371-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215371-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215371-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215371-001	AP	1	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215371-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215371-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215371-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215371-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215371-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215371-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215371-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215371-001	AP	1	`053a50430f4f…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215371-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215371-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215371-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A215371-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215371-001	AP	1	`a50c72e98297…`

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
Multiple Electrolytes pH 7.4	SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE AND MAGNESIUM CHLORIDE	Fresenius Kabi USA, LLC	84221110-b3f1-42f4-800c-ad1d3b330e9e	2022-11-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215371 application number: ANDA215371 ndc (product): 65219-389

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
65219-389	Multiple Electrolytes pH 7.4	sodium chloride, sodium gluconate, sodium acetate, potassium chloride and magnesium chloride	Fresenius Kabi USA, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
71687	ORIG	2022-08-01