Application 210016

Type: ANDA
Sponsor: GE HEALTHCARE

Application Products#

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

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

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	TE codes	Approval date
A210016-001	CLARISCAN	GADOTERATE MEGLUMINE	3.769GM/10ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-11-01
A210016-002	CLARISCAN	GADOTERATE MEGLUMINE	5.6535GM/15ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-11-01
A210016-003	CLARISCAN	GADOTERATE MEGLUMINE	7.538GM/20ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-11-01
A210016-004	CLARISCAN	GADOTERATE MEGLUMINE	37.69GM/100ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-08-04
A210016-005	CLARISCAN	GADOTERATE MEGLUMINE	1.8845GM/5ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-11-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A210016-001	AP
A210016-002	AP
A210016-003	AP
A210016-004	AP
A210016-005	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 5 · 195 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	A210016-001	CLARISCAN	3.769GM/10ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-11-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210016-002	CLARISCAN	5.6535GM/15ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-11-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210016-003	CLARISCAN	7.538GM/20ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-11-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210016-004	CLARISCAN	37.69GM/100ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-08-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210016-005	CLARISCAN	1.8845GM/5ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-11-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210016-001	CLARISCAN	3.769GM/10ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-11-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210016-002	CLARISCAN	5.6535GM/15ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-11-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210016-003	CLARISCAN	7.538GM/20ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-11-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210016-004	CLARISCAN	37.69GM/100ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-08-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210016-005	CLARISCAN	1.8845GM/5ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-11-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210016-001	CLARISCAN	3.769GM/10ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-11-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210016-002	CLARISCAN	5.6535GM/15ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-11-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210016-003	CLARISCAN	7.538GM/20ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-11-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210016-004	CLARISCAN	37.69GM/100ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-08-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210016-005	CLARISCAN	1.8845GM/5ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-11-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210016-001	CLARISCAN	3.769GM/10ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-11-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210016-002	CLARISCAN	5.6535GM/15ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-11-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210016-003	CLARISCAN	7.538GM/20ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-11-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210016-004	CLARISCAN	37.69GM/100ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-08-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210016-005	CLARISCAN	1.8845GM/5ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-11-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210016-001	CLARISCAN	3.769GM/10ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-11-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210016-002	CLARISCAN	5.6535GM/15ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-11-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210016-003	CLARISCAN	7.538GM/20ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-11-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210016-004	CLARISCAN	37.69GM/100ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-08-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210016-005	CLARISCAN	1.8845GM/5ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-11-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210016-001	CLARISCAN	3.769GM/10ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-11-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210016-002	CLARISCAN	5.6535GM/15ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-11-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210016-003	CLARISCAN	7.538GM/20ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-11-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210016-004	CLARISCAN	37.69GM/100ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-08-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210016-005	CLARISCAN	1.8845GM/5ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-11-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210016-001	CLARISCAN	3.769GM/10ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-11-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210016-002	CLARISCAN	5.6535GM/15ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-11-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210016-003	CLARISCAN	7.538GM/20ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-11-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210016-004	CLARISCAN	37.69GM/100ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-08-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210016-005	CLARISCAN	1.8845GM/5ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-11-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210016-001	CLARISCAN	3.769GM/10ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-11-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210016-002	CLARISCAN	5.6535GM/15ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-11-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210016-003	CLARISCAN	7.538GM/20ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-11-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210016-004	CLARISCAN	37.69GM/100ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-08-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210016-005	CLARISCAN	1.8845GM/5ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	2020-11-24	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 195 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	A210016-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210016-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210016-003	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210016-004	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210016-005	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210016-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210016-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210016-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210016-004	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210016-005	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210016-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210016-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210016-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210016-004	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210016-005	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210016-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210016-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210016-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210016-004	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210016-005	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210016-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210016-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210016-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210016-004	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210016-005	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210016-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210016-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210016-003	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210016-004	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210016-005	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210016-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210016-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210016-003	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210016-004	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210016-005	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210016-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210016-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210016-003	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210016-004	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210016-005	AP	1	`2680178bc6a6…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CLARISCAN	GADOTERATE MEGLUMINE	GE Healthcare	c9e273b3-481f-4899-8913-95aaddcc7662	2026-04-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210016 application number: ANDA210016 ndc (product): 0407-2943
CLARISCAN	GADOTERATE MEGLUMINE	GE Healthcare	6f8c9fac-c995-4bf4-950d-ab89deb291b5	2026-04-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210016 application number: ANDA210016 ndc (product): 0407-2943

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0407-2943	CLARISCAN	gadoterate meglumine	GE Healthcare	ANDA	Current
0407-2943	CLARISCAN	gadoterate meglumine	GE Healthcare	ANDA	Current
0407-2943	CLARISCAN	gadoterate meglumine	GE Healthcare	ANDA	Current
0407-2943	CLARISCAN	gadoterate meglumine	GE Healthcare	ANDA	Current
0407-2943	CLARISCAN	gadoterate meglumine	GE Healthcare	ANDA	Current
0407-2943	CLARISCAN	gadoterate meglumine	GE Healthcare	ANDA	Current
0407-2943	CLARISCAN	gadoterate meglumine	GE Healthcare	ANDA	Current
0407-2943	CLARISCAN	gadoterate meglumine	GE Healthcare	ANDA	Current
0407-2943	CLARISCAN	gadoterate meglumine	GE Healthcare	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
61136	ORIG	2019-12-04