Application 214271

Type: ANDA
Sponsor: JIANGSU PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IODIXANOL	IODIXANOL	INJECTABLE;INJECTION	55%	No	No
002	IODIXANOL	IODIXANOL	INJECTABLE;INJECTION	65.2%	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A214271-001	IODIXANOL	IODIXANOL	55%	INJECTABLE / INJECTION	AP		2022-05-19
A214271-002	IODIXANOL	IODIXANOL	65.2%	INJECTABLE / INJECTION	AP		2022-05-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A214271-001	AP
A214271-002	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 2 · 60 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
2026-08-18 06:07:40	2026-07	A214271-001	IODIXANOL	55%	INJECTABLE / INJECTION	AP	2022-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214271-002	IODIXANOL	65.2%	INJECTABLE / INJECTION	AP	2022-05-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214271-001	IODIXANOL	55%	INJECTABLE / INJECTION	AP	2022-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214271-002	IODIXANOL	65.2%	INJECTABLE / INJECTION	AP	2022-05-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214271-001	IODIXANOL	55%	INJECTABLE / INJECTION	AP	2022-05-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214271-002	IODIXANOL	65.2%	INJECTABLE / INJECTION	AP	2022-05-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214271-001	IODIXANOL	55%	INJECTABLE / INJECTION	AP	2022-05-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214271-002	IODIXANOL	65.2%	INJECTABLE / INJECTION	AP	2022-05-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214271-001	IODIXANOL	55%	INJECTABLE / INJECTION	AP	2022-05-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214271-002	IODIXANOL	65.2%	INJECTABLE / INJECTION	AP	2022-05-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214271-001	IODIXANOL	55%	INJECTABLE / INJECTION	AP	2022-05-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214271-002	IODIXANOL	65.2%	INJECTABLE / INJECTION	AP	2022-05-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214271-001	IODIXANOL	55%	INJECTABLE / INJECTION	AP	2022-05-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214271-002	IODIXANOL	65.2%	INJECTABLE / INJECTION	AP	2022-05-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214271-001	IODIXANOL	55%	INJECTABLE / INJECTION	AP	2022-05-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214271-002	IODIXANOL	65.2%	INJECTABLE / INJECTION	AP	2022-05-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214271-001	IODIXANOL	55%	INJECTABLE / INJECTION	AP	2022-05-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214271-002	IODIXANOL	65.2%	INJECTABLE / INJECTION	AP	2022-05-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214271-001	IODIXANOL	55%	INJECTABLE / INJECTION	AP	2022-05-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214271-002	IODIXANOL	65.2%	INJECTABLE / INJECTION	AP	2022-05-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214271-001	IODIXANOL	55%	INJECTABLE / INJECTION	AP	2022-05-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214271-002	IODIXANOL	65.2%	INJECTABLE / INJECTION	AP	2022-05-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214271-001	IODIXANOL	55%	INJECTABLE / INJECTION	AP	2022-05-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214271-002	IODIXANOL	65.2%	INJECTABLE / INJECTION	AP	2022-05-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214271-001	IODIXANOL	55%	INJECTABLE / INJECTION	AP	2022-05-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214271-002	IODIXANOL	65.2%	INJECTABLE / INJECTION	AP	2022-05-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214271-001	IODIXANOL	55%	INJECTABLE / INJECTION	AP	2022-05-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214271-002	IODIXANOL	65.2%	INJECTABLE / INJECTION	AP	2022-05-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214271-001	IODIXANOL	55%	INJECTABLE / INJECTION	AP	2022-05-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214271-002	IODIXANOL	65.2%	INJECTABLE / INJECTION	AP	2022-05-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214271-001	IODIXANOL	55%	INJECTABLE / INJECTION	AP	2022-05-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214271-002	IODIXANOL	65.2%	INJECTABLE / INJECTION	AP	2022-05-19	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214271-001	IODIXANOL	55%	INJECTABLE / INJECTION	AP	2022-05-19	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214271-002	IODIXANOL	65.2%	INJECTABLE / INJECTION	AP	2022-05-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214271-001	IODIXANOL	55%	INJECTABLE / INJECTION	AP	2022-05-19	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A214271-002	IODIXANOL	65.2%	INJECTABLE / INJECTION	AP	2022-05-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214271-001	IODIXANOL	55%	INJECTABLE / INJECTION	AP	2022-05-19	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A214271-002	IODIXANOL	65.2%	INJECTABLE / INJECTION	AP	2022-05-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214271-001	IODIXANOL	55%	INJECTABLE / INJECTION	AP	2022-05-19	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214271-002	IODIXANOL	65.2%	INJECTABLE / INJECTION	AP	2022-05-19	`a72a2bbeb626…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 60 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A214271-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214271-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214271-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214271-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214271-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214271-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214271-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214271-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214271-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214271-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214271-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214271-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214271-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214271-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214271-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214271-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214271-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214271-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214271-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214271-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214271-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214271-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214271-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214271-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214271-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214271-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214271-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214271-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214271-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214271-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214271-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214271-002	AP	1	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214271-001	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214271-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214271-001	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A214271-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214271-001	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A214271-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214271-001	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214271-002	AP	1	`a72a2bbeb626…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2023-12-20 04:57 UTC	2023-12	A214271-001	CGT	2023-01-09	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A214271-002	CGT	2023-01-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214271-001	CGT	2023-01-09	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214271-002	CGT	2023-01-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214271-001	CGT	2023-01-09	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214271-002	CGT	2023-01-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214271-001	CGT	2023-01-09	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214271-002	CGT	2023-01-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214271-001	CGT	2023-01-09	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214271-002	CGT	2023-01-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214271-001	CGT	2023-01-09	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A214271-002	CGT	2023-01-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214271-001	CGT	2023-01-09	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A214271-002	CGT	2023-01-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214271-001	CGT	2023-01-09	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214271-002	CGT	2023-01-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214271-001	CGT	2023-01-09	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A214271-002	CGT	2023-01-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214271-001	CGT	2023-01-09	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A214271-002	CGT	2023-01-09	`e64feba35796…`

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
Iodixanol	IODIXANOL	FRESENIUS KABI USA, LLC	0fe89ea2-04f7-46c5-9c35-220d8c144a95	2023-07-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214271 application number: ANDA214271 ndc (product): 65219-383 ndc (product): 65219-381

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
65219-381	Iodixanol	Iodixanol	FRESENIUS KABI USA, LLC	ANDA	Current
65219-381	Iodixanol	Iodixanol	FRESENIUS KABI USA, LLC	ANDA	Current
65219-383	Iodixanol	Iodixanol	FRESENIUS KABI USA, LLC	ANDA	Current
65219-383	Iodixanol	Iodixanol	FRESENIUS KABI USA, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
71882	ORIG	2022-08-25