Application 215304

Type: ANDA
Sponsor: JIANGSU HENGRUI MED

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GADOTERATE MEGLUMINE	GADOTERATE MEGLUMINE	SOLUTION;INTRAVENOUS	1.8845GM/5ML (376.9MG/ML)	No	No
002	GADOTERATE MEGLUMINE	GADOTERATE MEGLUMINE	SOLUTION;INTRAVENOUS	3.769GM/10ML (376.9MG/ML)	No	No
003	GADOTERATE MEGLUMINE	GADOTERATE MEGLUMINE	SOLUTION;INTRAVENOUS	5.6535GM/15ML (376.9MG/ML)	No	No
004	GADOTERATE MEGLUMINE	GADOTERATE MEGLUMINE	SOLUTION;INTRAVENOUS	7.538GM/20ML (376.9MG/ML)	No	No
005	GADOTERATE MEGLUMINE	GADOTERATE MEGLUMINE	SOLUTION;INTRAVENOUS	37.69GM/100ML (376.9MG/ML)	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	Approval date
A215304-001	GADOTERATE MEGLUMINE	GADOTERATE MEGLUMINE	1.8845GM/5ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	2022-04-11
A215304-002	GADOTERATE MEGLUMINE	GADOTERATE MEGLUMINE	3.769GM/10ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	2022-04-11
A215304-003	GADOTERATE MEGLUMINE	GADOTERATE MEGLUMINE	5.6535GM/15ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	2022-04-11
A215304-004	GADOTERATE MEGLUMINE	GADOTERATE MEGLUMINE	7.538GM/20ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	2022-04-11
A215304-005	GADOTERATE MEGLUMINE	GADOTERATE MEGLUMINE	37.69GM/100ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	2022-04-15

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 4 · 149 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
2026-09-14 22:38:34	2026-08	A215304-001	GADOTERATE MEGLUMINE	1.8845GM/5ML (376.9MG/ML)	SOLUTION / INTRAVENOUS		2022-04-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215304-002	GADOTERATE MEGLUMINE	3.769GM/10ML (376.9MG/ML)	SOLUTION / INTRAVENOUS		2022-04-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215304-003	GADOTERATE MEGLUMINE	5.6535GM/15ML (376.9MG/ML)	SOLUTION / INTRAVENOUS		2022-04-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215304-004	GADOTERATE MEGLUMINE	7.538GM/20ML (376.9MG/ML)	SOLUTION / INTRAVENOUS		2022-04-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215304-005	GADOTERATE MEGLUMINE	37.69GM/100ML (376.9MG/ML)	SOLUTION / INTRAVENOUS		2022-04-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215304-001	GADOTERATE MEGLUMINE	1.8845GM/5ML (376.9MG/ML)	SOLUTION / INTRAVENOUS		2022-04-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215304-002	GADOTERATE MEGLUMINE	3.769GM/10ML (376.9MG/ML)	SOLUTION / INTRAVENOUS		2022-04-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215304-003	GADOTERATE MEGLUMINE	5.6535GM/15ML (376.9MG/ML)	SOLUTION / INTRAVENOUS		2022-04-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215304-004	GADOTERATE MEGLUMINE	7.538GM/20ML (376.9MG/ML)	SOLUTION / INTRAVENOUS		2022-04-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215304-005	GADOTERATE MEGLUMINE	37.69GM/100ML (376.9MG/ML)	SOLUTION / INTRAVENOUS		2022-04-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215304-001	GADOTERATE MEGLUMINE	1.8845GM/5ML (376.9MG/ML)	SOLUTION / INTRAVENOUS		2022-04-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215304-002	GADOTERATE MEGLUMINE	3.769GM/10ML (376.9MG/ML)	SOLUTION / INTRAVENOUS		2022-04-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215304-003	GADOTERATE MEGLUMINE	5.6535GM/15ML (376.9MG/ML)	SOLUTION / INTRAVENOUS		2022-04-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215304-004	GADOTERATE MEGLUMINE	7.538GM/20ML (376.9MG/ML)	SOLUTION / INTRAVENOUS		2022-04-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215304-005	GADOTERATE MEGLUMINE	37.69GM/100ML (376.9MG/ML)	SOLUTION / INTRAVENOUS		2022-04-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215304-001	GADOTERATE MEGLUMINE	1.8845GM/5ML (376.9MG/ML)	SOLUTION / INTRAVENOUS		2022-04-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215304-002	GADOTERATE MEGLUMINE	3.769GM/10ML (376.9MG/ML)	SOLUTION / INTRAVENOUS		2022-04-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215304-003	GADOTERATE MEGLUMINE	5.6535GM/15ML (376.9MG/ML)	SOLUTION / INTRAVENOUS		2022-04-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215304-004	GADOTERATE MEGLUMINE	7.538GM/20ML (376.9MG/ML)	SOLUTION / INTRAVENOUS		2022-04-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215304-005	GADOTERATE MEGLUMINE	37.69GM/100ML (376.9MG/ML)	SOLUTION / INTRAVENOUS		2022-04-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215304-001	GADOTERATE MEGLUMINE	1.8845GM/5ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215304-002	GADOTERATE MEGLUMINE	3.769GM/10ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215304-003	GADOTERATE MEGLUMINE	5.6535GM/15ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215304-004	GADOTERATE MEGLUMINE	7.538GM/20ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215304-005	GADOTERATE MEGLUMINE	37.69GM/100ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215304-001	GADOTERATE MEGLUMINE	1.8845GM/5ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215304-002	GADOTERATE MEGLUMINE	3.769GM/10ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215304-003	GADOTERATE MEGLUMINE	5.6535GM/15ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215304-004	GADOTERATE MEGLUMINE	7.538GM/20ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215304-005	GADOTERATE MEGLUMINE	37.69GM/100ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215304-001	GADOTERATE MEGLUMINE	1.8845GM/5ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215304-002	GADOTERATE MEGLUMINE	3.769GM/10ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215304-003	GADOTERATE MEGLUMINE	5.6535GM/15ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215304-004	GADOTERATE MEGLUMINE	7.538GM/20ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215304-005	GADOTERATE MEGLUMINE	37.69GM/100ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215304-001	GADOTERATE MEGLUMINE	1.8845GM/5ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215304-002	GADOTERATE MEGLUMINE	3.769GM/10ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215304-003	GADOTERATE MEGLUMINE	5.6535GM/15ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215304-004	GADOTERATE MEGLUMINE	7.538GM/20ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215304-005	GADOTERATE MEGLUMINE	37.69GM/100ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-15	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 3 of 4 · 124 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215304-002	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215304-003	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215304-004	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215304-005	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215304-001	AP	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215304-002	AP	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215304-003	AP	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215304-004	AP	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215304-005	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215304-001	AP	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215304-002	AP	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215304-003	AP	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215304-004	AP	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215304-005	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215304-001	AP	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215304-002	AP	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215304-003	AP	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215304-004	AP	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215304-005	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215304-001	AP	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A215304-002	AP	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A215304-003	AP	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A215304-004	AP	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A215304-005	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215304-001	AP	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A215304-002	AP	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A215304-003	AP	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A215304-004	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215304-001	AP	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215304-002	AP	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215304-003	AP	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215304-004	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215304-001	AP	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A215304-002	AP	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A215304-003	AP	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A215304-004	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215304-001	AP	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A215304-002	AP	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A215304-003	AP	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A215304-004	AP	1	`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
Gadoterate Meglumine	GADOTERATE MEGLUMINE	Fresenius Kabi USA, LLC	e0655aac-9508-4141-94f5-fcca6af1c41d	2025-11-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215304 application number: ANDA215304 ndc (product): 65219-082 ndc (product): 65219-080 ndc (product): 65219-084 ndc (product): 65219-086

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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
65219-080	Gadoterate Meglumine	gadoterate meglumine	Fresenius Kabi USA, LLC	ANDA	Current
65219-082	Gadoterate Meglumine	gadoterate meglumine	Fresenius Kabi USA, LLC	ANDA	Current
65219-084	Gadoterate Meglumine	gadoterate meglumine	Fresenius Kabi USA, LLC	ANDA	Current
65219-086	Gadoterate Meglumine	gadoterate meglumine	Fresenius Kabi USA, LLC	ANDA	Current