Application 021357

Type: NDA
Sponsor: BRACCO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MULTIHANCE	GADOBENATE DIMEGLUMINE	INJECTABLE;INTRAVENOUS	2.645GM/5ML (529MG/ML)	Yes	Yes
002	MULTIHANCE	GADOBENATE DIMEGLUMINE	INJECTABLE;INTRAVENOUS	5.29GM/10ML (529MG/ML)	Yes	Yes
003	MULTIHANCE	GADOBENATE DIMEGLUMINE	INJECTABLE;INTRAVENOUS	7.935GM/15ML (529MG/ML)	Yes	Yes
004	MULTIHANCE	GADOBENATE DIMEGLUMINE	INJECTABLE;INTRAVENOUS	10.58GM/20ML (529MG/ML)	Yes	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N021357-001	MULTIHANCE	GADOBENATE DIMEGLUMINE	2.645GM/5ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23
N021357-002	MULTIHANCE	GADOBENATE DIMEGLUMINE	5.29GM/10ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23
N021357-003	MULTIHANCE	GADOBENATE DIMEGLUMINE	7.935GM/15ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23
N021357-004	MULTIHANCE	GADOBENATE DIMEGLUMINE	10.58GM/20ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23

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 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021357-001	MULTIHANCE	2.645GM/5ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021357-002	MULTIHANCE	5.29GM/10ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021357-003	MULTIHANCE	7.935GM/15ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021357-004	MULTIHANCE	10.58GM/20ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021357-001	MULTIHANCE	2.645GM/5ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021357-002	MULTIHANCE	5.29GM/10ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021357-003	MULTIHANCE	7.935GM/15ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021357-004	MULTIHANCE	10.58GM/20ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021357-001	MULTIHANCE	2.645GM/5ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021357-002	MULTIHANCE	5.29GM/10ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021357-003	MULTIHANCE	7.935GM/15ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021357-004	MULTIHANCE	10.58GM/20ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021357-001	MULTIHANCE	2.645GM/5ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021357-002	MULTIHANCE	5.29GM/10ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021357-003	MULTIHANCE	7.935GM/15ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021357-004	MULTIHANCE	10.58GM/20ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021357-001	MULTIHANCE	2.645GM/5ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021357-002	MULTIHANCE	5.29GM/10ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021357-003	MULTIHANCE	7.935GM/15ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021357-004	MULTIHANCE	10.58GM/20ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021357-001	MULTIHANCE	2.645GM/5ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021357-002	MULTIHANCE	5.29GM/10ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021357-003	MULTIHANCE	7.935GM/15ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021357-004	MULTIHANCE	10.58GM/20ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021357-001	MULTIHANCE	2.645GM/5ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021357-002	MULTIHANCE	5.29GM/10ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021357-003	MULTIHANCE	7.935GM/15ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021357-004	MULTIHANCE	10.58GM/20ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021357-001	MULTIHANCE	2.645GM/5ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021357-002	MULTIHANCE	5.29GM/10ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021357-003	MULTIHANCE	7.935GM/15ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021357-004	MULTIHANCE	10.58GM/20ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021357-001	MULTIHANCE	2.645GM/5ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021357-002	MULTIHANCE	5.29GM/10ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021357-003	MULTIHANCE	7.935GM/15ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021357-004	MULTIHANCE	10.58GM/20ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021357-001	MULTIHANCE	2.645GM/5ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021357-002	MULTIHANCE	5.29GM/10ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021357-003	MULTIHANCE	7.935GM/15ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021357-004	MULTIHANCE	10.58GM/20ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`5bbf6a4d5a75…`

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
MultiHance	GADOBENATE DIMEGLUMINE	BRACCO DIAGNOSTICS INC	59077a3e-5f03-4342-ae24-856267545631	2025-03-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021357 application number: NDA021357 ndc (product): 0270-5164

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
0270-5164	MultiHance	gadobenate dimeglumine	BRACCO DIAGNOSTICS INC	NDA	Current
0270-5164	MultiHance	gadobenate dimeglumine	BRACCO DIAGNOSTICS INC	NDA	Current
0270-5164	MultiHance	gadobenate dimeglumine	BRACCO DIAGNOSTICS INC	NDA	Current
0270-5164	MultiHance	gadobenate dimeglumine	BRACCO DIAGNOSTICS INC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81499	SUPPL	2025-03-07
81498	SUPPL	2025-03-07
81450	SUPPL	2025-03-06
79418	SUPPL	2024-08-16
79405	SUPPL	2024-08-16
79203	SUPPL	2024-07-24
79186	SUPPL	2024-07-24
77336	SUPPL	2024-02-01
77344	SUPPL	2024-01-29
56863	SUPPL	2018-12-20
56436	SUPPL	2018-11-14
56308	SUPPL	2018-11-06
53900	SUPPL	2018-05-01
53899	SUPPL	2018-05-01
53828	SUPPL	2018-04-27
53827	SUPPL	2018-04-27
51870	SUPPL	2018-01-26
51343	SUPPL	2018-01-19
49786	SUPPL	2017-09-19
49768	SUPPL	2017-09-18
36747	SUPPL	2013-08-09
5156	SUPPL	2013-08-01
36746	SUPPL	2012-07-10
5155	SUPPL	2012-07-09
5154	SUPPL	2010-12-22
15283	SUPPL	2010-12-20
5153	SUPPL	2010-03-22
15282	SUPPL	2010-03-18
27580	SUPPL	2009-11-10
15281	SUPPL	2009-10-14
27579	SUPPL	2007-09-06
15280	SUPPL	2007-09-06
23649	ORIG	2006-06-09
21614	ORIG	2005-03-28
36745	ORIG	2004-12-03
5152	ORIG	2004-12-02
53281	ORIG	1900-01-01
53280	ORIG	1900-01-01
53279	ORIG	1900-01-01