Application 215982

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	37.69GM/100ML (376.9MG/ML)	No	No

Source provenance: Browse the complete Orange Book source catalog.

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
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215982-001	GADOTERATE MEGLUMINE	37.69GM/100ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-15	`5c6f7cd8ea54…`
2023-01-26 05:58 UTC	2023-01	A215982-001	GADOTERATE MEGLUMINE	37.69GM/100ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215982-001	GADOTERATE MEGLUMINE	37.69GM/100ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215982-001	GADOTERATE MEGLUMINE	37.69GM/100ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215982-001	GADOTERATE MEGLUMINE	37.69GM/100ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A215982-001	GADOTERATE MEGLUMINE	37.69GM/100ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-04-15	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215982-001	AP	1	`5c6f7cd8ea54…`
2023-01-26 05:58 UTC	2023-01	A215982-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215982-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215982-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215982-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A215982-001	AP	1	`cb3db0bc1861…`

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	fbebe7f2-a0c2-4fd5-b421-8fbcbaf46709	2025-11-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215982 application number: ANDA215982 ndc (product): 65219-088

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
65219-088	Gadoterate Meglumine	gadoterate meglumine	Fresenius Kabi USA, LLC	ANDA	Current