Application 214623

Type: ANDA
Sponsor: FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CARDIOPLEGIC IN PLASTIC CONTAINER	CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	SOLUTION;PERFUSION, CARDIAC	17.6MG/100ML;325.3MG/100ML;119.3MG/100ML;643MG/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
A214623-001	CARDIOPLEGIC IN PLASTIC CONTAINER	CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	17.6MG/100ML;325.3MG/100ML;119.3MG/100ML;643MG/100ML	SOLUTION / PERFUSION, CARDIAC	AT		2022-02-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214623-001	AT

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	A214623-001	CARDIOPLEGIC IN PLASTIC CONTAINER	17.6MG/100ML;325.3MG/100ML;119.3MG/100ML;643MG/100ML	SOLUTION / PERFUSION, CARDIAC	AT	2022-02-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214623-001	CARDIOPLEGIC IN PLASTIC CONTAINER	17.6MG/100ML;325.3MG/100ML;119.3MG/100ML;643MG/100ML	SOLUTION / PERFUSION, CARDIAC	AT	2022-02-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214623-001	CARDIOPLEGIC IN PLASTIC CONTAINER	17.6MG/100ML;325.3MG/100ML;119.3MG/100ML;643MG/100ML	SOLUTION / PERFUSION, CARDIAC	AT	2022-02-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214623-001	CARDIOPLEGIC IN PLASTIC CONTAINER	17.6MG/100ML;325.3MG/100ML;119.3MG/100ML;643MG/100ML	SOLUTION / PERFUSION, CARDIAC	AT	2022-02-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214623-001	CARDIOPLEGIC IN PLASTIC CONTAINER	17.6MG/100ML;325.3MG/100ML;119.3MG/100ML;643MG/100ML	SOLUTION / PERFUSION, CARDIAC	AT	2022-02-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214623-001	CARDIOPLEGIC IN PLASTIC CONTAINER	17.6MG/100ML;325.3MG/100ML;119.3MG/100ML;643MG/100ML	SOLUTION / PERFUSION, CARDIAC	AT	2022-02-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214623-001	CARDIOPLEGIC IN PLASTIC CONTAINER	17.6MG/100ML;325.3MG/100ML;119.3MG/100ML;643MG/100ML	SOLUTION / PERFUSION, CARDIAC	AT	2022-02-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214623-001	CARDIOPLEGIC IN PLASTIC CONTAINER	17.6MG/100ML;325.3MG/100ML;119.3MG/100ML;643MG/100ML	SOLUTION / PERFUSION, CARDIAC	AT	2022-02-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214623-001	CARDIOPLEGIC IN PLASTIC CONTAINER	17.6MG/100ML;325.3MG/100ML;119.3MG/100ML;643MG/100ML	SOLUTION / PERFUSION, CARDIAC	AT	2022-02-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214623-001	CARDIOPLEGIC IN PLASTIC CONTAINER	17.6MG/100ML;325.3MG/100ML;119.3MG/100ML;643MG/100ML	SOLUTION / PERFUSION, CARDIAC	AT	2022-02-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214623-001	CARDIOPLEGIC IN PLASTIC CONTAINER	17.6MG/100ML;325.3MG/100ML;119.3MG/100ML;643MG/100ML	SOLUTION / PERFUSION, CARDIAC	AT	2022-02-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214623-001	CARDIOPLEGIC IN PLASTIC CONTAINER	17.6MG/100ML;325.3MG/100ML;119.3MG/100ML;643MG/100ML	SOLUTION / PERFUSION, CARDIAC	AT	2022-02-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214623-001	CARDIOPLEGIC IN PLASTIC CONTAINER	17.6MG/100ML;325.3MG/100ML;119.3MG/100ML;643MG/100ML	SOLUTION / PERFUSION, CARDIAC	AT	2022-02-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214623-001	CARDIOPLEGIC IN PLASTIC CONTAINER	17.6MG/100ML;325.3MG/100ML;119.3MG/100ML;643MG/100ML	SOLUTION / PERFUSION, CARDIAC	AT	2022-02-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214623-001	CARDIOPLEGIC IN PLASTIC CONTAINER	17.6MG/100ML;325.3MG/100ML;119.3MG/100ML;643MG/100ML	SOLUTION / PERFUSION, CARDIAC	AT	2022-02-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214623-001	CARDIOPLEGIC IN PLASTIC CONTAINER	17.6MG/100ML;325.3MG/100ML;119.3MG/100ML;643MG/100ML	SOLUTION / PERFUSION, CARDIAC	AT	2022-02-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214623-001	CARDIOPLEGIC IN PLASTIC CONTAINER	17.6MG/100ML;325.3MG/100ML;119.3MG/100ML;643MG/100ML	SOLUTION / PERFUSION, CARDIAC	AT	2022-02-18	`4b0b4de00fa7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214623-001	CARDIOPLEGIC IN PLASTIC CONTAINER	17.6MG/100ML;325.3MG/100ML;119.3MG/100ML;643MG/100ML	SOLUTION / PERFUSION, CARDIAC	AT	2022-02-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214623-001	CARDIOPLEGIC IN PLASTIC CONTAINER	17.6MG/100ML;325.3MG/100ML;119.3MG/100ML;643MG/100ML	SOLUTION / PERFUSION, CARDIAC	AT	2022-02-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214623-001	CARDIOPLEGIC IN PLASTIC CONTAINER	17.6MG/100ML;325.3MG/100ML;119.3MG/100ML;643MG/100ML	SOLUTION / PERFUSION, CARDIAC	AT	2022-02-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214623-001	CARDIOPLEGIC IN PLASTIC CONTAINER	17.6MG/100ML;325.3MG/100ML;119.3MG/100ML;643MG/100ML	SOLUTION / PERFUSION, CARDIAC	AT	2022-02-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214623-001	CARDIOPLEGIC IN PLASTIC CONTAINER	17.6MG/100ML;325.3MG/100ML;119.3MG/100ML;643MG/100ML	SOLUTION / PERFUSION, CARDIAC	AT	2022-02-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214623-001	CARDIOPLEGIC IN PLASTIC CONTAINER	17.6MG/100ML;325.3MG/100ML;119.3MG/100ML;643MG/100ML	SOLUTION / PERFUSION, CARDIAC	AT	2022-02-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214623-001	CARDIOPLEGIC IN PLASTIC CONTAINER	17.6MG/100ML;325.3MG/100ML;119.3MG/100ML;643MG/100ML	SOLUTION / PERFUSION, CARDIAC	AT	2022-02-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214623-001	CARDIOPLEGIC IN PLASTIC CONTAINER	17.6MG/100ML;325.3MG/100ML;119.3MG/100ML;643MG/100ML	SOLUTION / PERFUSION, CARDIAC	AT	2022-02-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214623-001	CARDIOPLEGIC IN PLASTIC CONTAINER	17.6MG/100ML;325.3MG/100ML;119.3MG/100ML;643MG/100ML	SOLUTION / PERFUSION, CARDIAC	AT	2022-02-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214623-001	CARDIOPLEGIC IN PLASTIC CONTAINER	17.6MG/100ML;325.3MG/100ML;119.3MG/100ML;643MG/100ML	SOLUTION / PERFUSION, CARDIAC		2022-02-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214623-001	CARDIOPLEGIC IN PLASTIC CONTAINER	17.6MG/100ML;325.3MG/100ML;119.3MG/100ML;643MG/100ML	SOLUTION / PERFUSION, CARDIAC		2022-02-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214623-001	CARDIOPLEGIC IN PLASTIC CONTAINER	17.6MG/100ML;325.3MG/100ML;119.3MG/100ML;643MG/100ML	SOLUTION / PERFUSION, CARDIAC		2022-02-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214623-001	CARDIOPLEGIC IN PLASTIC CONTAINER	17.6MG/100ML;325.3MG/100ML;119.3MG/100ML;643MG/100ML	SOLUTION / PERFUSION, CARDIAC	AT	2022-02-18	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214623-001	CARDIOPLEGIC IN PLASTIC CONTAINER	17.6MG/100ML;325.3MG/100ML;119.3MG/100ML;643MG/100ML	SOLUTION / PERFUSION, CARDIAC	AT	2022-02-18	`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	A214623-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214623-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214623-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214623-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214623-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214623-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214623-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214623-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214623-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214623-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214623-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214623-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214623-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214623-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214623-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214623-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214623-001	AT	1	`4b0b4de00fa7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214623-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214623-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214623-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214623-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214623-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214623-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214623-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214623-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214623-001	AT	1	`3bdfa0b2c4d7…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214623-001	AT	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214623-001	AT	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
Cardioplegic Solution	POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, AND MAGNESIUM CHLORIDE	Fresenius Kabi, USA, LLC	eb360dc4-88d6-4b28-9b61-bc359e16bd22	2022-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214623 application number: ANDA214623 ndc (product): 65219-258

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
65219-258	Cardioplegic Solution	POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, and MAGNESIUM CHLORIDE	Fresenius Kabi, USA, LLC	ANDA	Current