Application 075323

Type: ANDA
Sponsor: BAXTER HLTHCARE

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 44.

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
A075323-001	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		2000-04-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075323-001	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.

Product history page 2 of 2 · 44 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
2022-10-28 04:53 UTC	2022-10	A075323-001	CARDIOPLEGIC IN PLASTIC CONTAINER	17.6MG/100ML;325.3MG/100ML;119.3MG/100ML;643MG/100ML	SOLUTION / PERFUSION, CARDIAC	AT	2000-04-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075323-001	CARDIOPLEGIC IN PLASTIC CONTAINER	17.6MG/100ML;325.3MG/100ML;119.3MG/100ML;643MG/100ML	SOLUTION / PERFUSION, CARDIAC	AT	2000-04-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075323-001	CARDIOPLEGIC IN PLASTIC CONTAINER	17.6MG/100ML;325.3MG/100ML;119.3MG/100ML;643MG/100ML	SOLUTION / PERFUSION, CARDIAC	AT	2000-04-21	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A075323-001	CARDIOPLEGIC IN PLASTIC CONTAINER	17.6MG/100ML;325.3MG/100ML;119.3MG/100ML;643MG/100ML	SOLUTION / PERFUSION, CARDIAC	AT	2000-04-21	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A075323-001	AT	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A075323-001	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075323-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075323-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075323-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075323-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075323-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075323-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075323-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075323-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075323-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075323-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075323-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075323-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075323-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075323-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075323-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075323-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075323-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075323-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075323-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075323-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075323-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075323-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075323-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075323-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075323-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075323-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075323-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075323-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075323-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075323-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075323-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075323-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075323-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075323-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075323-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075323-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075323-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075323-001	AT	1	`3a93d1ddd44b…`

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	CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, POTASSIUM CHLORIDE AND SODIUM CHLORIDE	Baxter Healthcare Corporation	1fd50ce5-2799-4c26-81da-02cf0578dd9e	2020-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075323 application number: ANDA075323 ndc (product): 0338-0341

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 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0338-0341	Cardioplegic	Calcium Chloride, Magnesium Chloride, Potassium Chloride and Sodium Chloride	Baxter Healthcare Corporation	ANDA	Current
0338-0341	Cardioplegic	Calcium Chloride, Magnesium Chloride, Potassium Chloride and Sodium Chloride	Baxter Healthcare Corporation	ANDA	Current
0338-0341	Cardioplegic	Calcium Chloride, Magnesium Chloride, Potassium Chloride and Sodium Chloride	Baxter Healthcare Corporation	ANDA	Current
0338-0341	Cardioplegic	Calcium Chloride, Magnesium Chloride, Potassium Chloride and Sodium Chloride	Baxter Healthcare Corporation	ANDA	Current
0338-0341	Cardioplegic	Calcium Chloride, Magnesium Chloride, Potassium Chloride and Sodium Chloride	Baxter Healthcare Corporation	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8619	ORIG	2000-04-21