Application 204781

Type: NDA
Sponsor: GUERBET

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DOTAREM	GADOTERATE MEGLUMINE	SOLUTION;INTRAVENOUS	37.69GM/100ML (376.9MG/ML)	Yes	Yes
002	DOTAREM	GADOTERATE MEGLUMINE	SOLUTION;INTRAVENOUS	3.769GM/10ML (376.9MG/ML)	Yes	Yes
003	DOTAREM	GADOTERATE MEGLUMINE	SOLUTION;INTRAVENOUS	5.6535GM/15ML (376.9MG/ML)	Yes	Yes
004	DOTAREM	GADOTERATE MEGLUMINE	SOLUTION;INTRAVENOUS	7.538GM/20ML (376.9MG/ML)	Yes	Yes
005	DOTAREM	GADOTERATE MEGLUMINE	SOLUTION;INTRAVENOUS	1.8845GM/5ML (376.9MG/ML)	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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	RLD / RS	Approval date
N204781-001	DOTAREM	GADOTERATE MEGLUMINE	37.69GM/100ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-03-20
N204781-002	DOTAREM	GADOTERATE MEGLUMINE	3.769GM/10ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-03-20
N204781-003	DOTAREM	GADOTERATE MEGLUMINE	5.6535GM/15ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-03-20
N204781-004	DOTAREM	GADOTERATE MEGLUMINE	7.538GM/20ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-03-20
N204781-005	DOTAREM	GADOTERATE MEGLUMINE	1.8845GM/5ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2017-03-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N204781-001	AP
N204781-002	AP
N204781-003	AP
N204781-004	AP
N204781-005	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 6 · 205 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N204781-001	DOTAREM	37.69GM/100ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-03-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204781-002	DOTAREM	3.769GM/10ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-03-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204781-003	DOTAREM	5.6535GM/15ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-03-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204781-004	DOTAREM	7.538GM/20ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-03-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204781-005	DOTAREM	1.8845GM/5ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2017-03-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204781-001	DOTAREM	37.69GM/100ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-03-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204781-002	DOTAREM	3.769GM/10ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-03-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204781-003	DOTAREM	5.6535GM/15ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-03-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204781-004	DOTAREM	7.538GM/20ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-03-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204781-005	DOTAREM	1.8845GM/5ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2017-03-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204781-001	DOTAREM	37.69GM/100ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-03-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204781-002	DOTAREM	3.769GM/10ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-03-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204781-003	DOTAREM	5.6535GM/15ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-03-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204781-004	DOTAREM	7.538GM/20ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-03-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204781-005	DOTAREM	1.8845GM/5ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2017-03-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204781-001	DOTAREM	37.69GM/100ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-03-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204781-002	DOTAREM	3.769GM/10ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-03-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204781-003	DOTAREM	5.6535GM/15ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-03-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204781-004	DOTAREM	7.538GM/20ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-03-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204781-005	DOTAREM	1.8845GM/5ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2017-03-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204781-001	DOTAREM	37.69GM/100ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-03-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204781-002	DOTAREM	3.769GM/10ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-03-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204781-003	DOTAREM	5.6535GM/15ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-03-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204781-004	DOTAREM	7.538GM/20ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-03-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204781-005	DOTAREM	1.8845GM/5ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2017-03-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204781-001	DOTAREM	37.69GM/100ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-03-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204781-002	DOTAREM	3.769GM/10ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-03-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204781-003	DOTAREM	5.6535GM/15ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-03-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204781-004	DOTAREM	7.538GM/20ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-03-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204781-005	DOTAREM	1.8845GM/5ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2017-03-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204781-001	DOTAREM	37.69GM/100ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-03-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204781-002	DOTAREM	3.769GM/10ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-03-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204781-003	DOTAREM	5.6535GM/15ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-03-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204781-004	DOTAREM	7.538GM/20ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-03-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204781-005	DOTAREM	1.8845GM/5ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2017-03-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204781-001	DOTAREM	37.69GM/100ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-03-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204781-002	DOTAREM	3.769GM/10ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-03-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204781-003	DOTAREM	5.6535GM/15ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-03-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204781-004	DOTAREM	7.538GM/20ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2013-03-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204781-005	DOTAREM	1.8845GM/5ML (376.9MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2017-03-31	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 190 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N204781-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204781-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204781-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204781-004	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204781-005	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204781-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204781-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204781-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204781-004	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204781-005	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204781-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204781-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204781-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204781-004	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204781-005	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204781-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204781-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204781-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204781-004	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204781-005	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204781-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204781-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204781-003	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204781-004	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204781-005	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204781-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204781-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204781-003	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204781-004	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204781-005	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204781-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204781-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204781-003	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204781-004	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204781-005	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204781-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204781-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204781-003	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204781-004	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204781-005	AP	1	`5bbf6a4d5a75…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N204781-001	NPP	2020-08-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204781-002	NPP	2020-08-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204781-003	NPP	2020-08-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204781-004	NPP	2020-08-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204781-005	NPP	2020-08-25	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N204781-001	NPP	2020-08-25	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N204781-002	NPP	2020-08-25	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N204781-003	NPP	2020-08-25	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N204781-004	NPP	2020-08-25	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N204781-005	NPP	2020-08-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N204781-001	NPP	2020-08-25	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N204781-002	NPP	2020-08-25	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N204781-003	NPP	2020-08-25	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N204781-004	NPP	2020-08-25	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N204781-005	NPP	2020-08-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N204781-001	NPP	2020-08-25	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N204781-002	NPP	2020-08-25	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N204781-003	NPP	2020-08-25	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N204781-004	NPP	2020-08-25	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N204781-005	NPP	2020-08-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N204781-001	NPP	2020-08-25	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N204781-002	NPP	2020-08-25	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N204781-003	NPP	2020-08-25	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N204781-004	NPP	2020-08-25	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N204781-005	NPP	2020-08-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N204781-001	NPP	2020-08-25	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N204781-002	NPP	2020-08-25	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N204781-003	NPP	2020-08-25	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N204781-004	NPP	2020-08-25	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N204781-005	NPP	2020-08-25	`ea99ee380514…`

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
DOTAREM	GADOTERATE MEGLUMINE	Guerbet LLC	e2c4a5ac-2df2-4cf4-a2d3-6fbe2d898ebc	2025-03-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 204781 application number: NDA204781 ndc (product): 67684-2001 ndc (product): 67684-3001 ndc (product): 67684-2000
DOTAREM	GADOTERATE MEGLUMINE	Guerbet LLC	82b83e61-6af8-4225-aa39-8cbf206f65b0	2025-03-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 204781 application number: NDA204781 ndc (product): 67684-2001 ndc (product): 67684-2000

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
67684-2000	DOTAREM	gadoterate meglumine	Guerbet LLC	NDA	Current
67684-2000	DOTAREM	gadoterate meglumine	Guerbet LLC	NDA	Current
67684-2000	DOTAREM	gadoterate meglumine	Guerbet LLC	NDA	Current
67684-2000	DOTAREM	gadoterate meglumine	Guerbet LLC	NDA	Current
67684-2000	DOTAREM	gadoterate meglumine	Guerbet LLC	NDA	Current
67684-2000	DOTAREM	gadoterate meglumine	Guerbet LLC	NDA	Current
67684-2000	DOTAREM	gadoterate meglumine	Guerbet LLC	NDA	Current
67684-2000	DOTAREM	gadoterate meglumine	Guerbet LLC	NDA	Current
67684-2000	DOTAREM	gadoterate meglumine	Guerbet LLC	NDA	Current
67684-2000	DOTAREM	gadoterate meglumine	Guerbet LLC	NDA	Current
67684-2000	DOTAREM	gadoterate meglumine	Guerbet LLC	NDA	Current
67684-2001	DOTAREM	gadoterate meglumine	Guerbet LLC	NDA	Current
67684-2001	DOTAREM	gadoterate meglumine	Guerbet LLC	NDA	Current
67684-2001	DOTAREM	gadoterate meglumine	Guerbet LLC	NDA	Current
67684-2001	DOTAREM	gadoterate meglumine	Guerbet LLC	NDA	Current
67684-2001	DOTAREM	gadoterate meglumine	Guerbet LLC	NDA	Current
67684-2001	DOTAREM	gadoterate meglumine	Guerbet LLC	NDA	Current
67684-3001	DOTAREM	gadoterate meglumine	Guerbet LLC	NDA	Current
67684-3001	DOTAREM	gadoterate meglumine	Guerbet LLC	NDA	Current
67684-3001	DOTAREM	gadoterate meglumine	Guerbet LLC	NDA	Current
67684-3001	DOTAREM	gadoterate meglumine	Guerbet LLC	NDA	Current
67684-3001	DOTAREM	gadoterate meglumine	Guerbet LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81489	SUPPL	2025-03-07
81488	SUPPL	2025-03-07
81455	SUPPL	2025-03-06
81454	SUPPL	2025-03-06
79889	SUPPL	2024-10-15
79415	SUPPL	2024-08-16
79197	SUPPL	2024-07-24
79182	SUPPL	2024-07-24
77347	SUPPL	2024-01-29
77340	SUPPL	2024-01-29
59452	SUPPL	2019-07-25
59451	SUPPL	2019-07-25
59436	SUPPL	2019-07-24
56470	SUPPL	2018-11-15
56300	SUPPL	2018-11-06
56294	SUPPL	2018-11-06
53911	SUPPL	2018-05-01
53835	SUPPL	2018-04-27
49792	SUPPL	2017-09-19
49744	SUPPL	2017-09-15
49559	SUPPL	2017-08-28
49558	SUPPL	2017-08-28
44910	ORIG	2013-05-10
43478	ORIG	2013-05-10
19598	ORIG	2013-03-26
32589	ORIG	2013-03-22
63045	SUPPL	1900-01-01
63044	SUPPL	1900-01-01
63043	SUPPL	1900-01-01
51146	ORIG	1900-01-01
51145	ORIG	1900-01-01
51144	ORIG	1900-01-01