Application 021358

Type: NDA
Sponsor: BRACCO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MULTIHANCE MULTIPACK	GADOBENATE DIMEGLUMINE	INJECTABLE;INTRAVENOUS	26.45GM/50ML (529MG/ML)	Yes	Yes
002	MULTIHANCE MULTIPACK	GADOBENATE DIMEGLUMINE	INJECTABLE;INTRAVENOUS	52.9GM/100ML (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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021358-001	MULTIHANCE MULTIPACK	GADOBENATE DIMEGLUMINE	26.45GM/50ML (529MG/ML)	INJECTABLE / INTRAVENOUS		RLD, RS	2004-11-23
N021358-002	MULTIHANCE MULTIPACK	GADOBENATE DIMEGLUMINE	52.9GM/100ML (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 3 · 86 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	N021358-001	MULTIHANCE MULTIPACK	26.45GM/50ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021358-002	MULTIHANCE MULTIPACK	52.9GM/100ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021358-001	MULTIHANCE MULTIPACK	26.45GM/50ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021358-002	MULTIHANCE MULTIPACK	52.9GM/100ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021358-001	MULTIHANCE MULTIPACK	26.45GM/50ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021358-002	MULTIHANCE MULTIPACK	52.9GM/100ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021358-001	MULTIHANCE MULTIPACK	26.45GM/50ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021358-002	MULTIHANCE MULTIPACK	52.9GM/100ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021358-001	MULTIHANCE MULTIPACK	26.45GM/50ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021358-002	MULTIHANCE MULTIPACK	52.9GM/100ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021358-001	MULTIHANCE MULTIPACK	26.45GM/50ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021358-002	MULTIHANCE MULTIPACK	52.9GM/100ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021358-001	MULTIHANCE MULTIPACK	26.45GM/50ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021358-002	MULTIHANCE MULTIPACK	52.9GM/100ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021358-001	MULTIHANCE MULTIPACK	26.45GM/50ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021358-002	MULTIHANCE MULTIPACK	52.9GM/100ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021358-001	MULTIHANCE MULTIPACK	26.45GM/50ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021358-002	MULTIHANCE MULTIPACK	52.9GM/100ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021358-001	MULTIHANCE MULTIPACK	26.45GM/50ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021358-002	MULTIHANCE MULTIPACK	52.9GM/100ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021358-001	MULTIHANCE MULTIPACK	26.45GM/50ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021358-002	MULTIHANCE MULTIPACK	52.9GM/100ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021358-001	MULTIHANCE MULTIPACK	26.45GM/50ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021358-002	MULTIHANCE MULTIPACK	52.9GM/100ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021358-001	MULTIHANCE MULTIPACK	26.45GM/50ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021358-002	MULTIHANCE MULTIPACK	52.9GM/100ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021358-001	MULTIHANCE MULTIPACK	26.45GM/50ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021358-002	MULTIHANCE MULTIPACK	52.9GM/100ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021358-001	MULTIHANCE MULTIPACK	26.45GM/50ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021358-002	MULTIHANCE MULTIPACK	52.9GM/100ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021358-001	MULTIHANCE MULTIPACK	26.45GM/50ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021358-002	MULTIHANCE MULTIPACK	52.9GM/100ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021358-001	MULTIHANCE MULTIPACK	26.45GM/50ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021358-002	MULTIHANCE MULTIPACK	52.9GM/100ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021358-001	MULTIHANCE MULTIPACK	26.45GM/50ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021358-002	MULTIHANCE MULTIPACK	52.9GM/100ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021358-001	MULTIHANCE MULTIPACK	26.45GM/50ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021358-002	MULTIHANCE MULTIPACK	52.9GM/100ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021358-001	MULTIHANCE MULTIPACK	26.45GM/50ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021358-002	MULTIHANCE MULTIPACK	52.9GM/100ML (529MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2004-11-23	`74a2ff9319b5…`

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	f63abe56-46d9-4e32-afb1-f4e22370717d	2025-03-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021358 application number: NDA021358 ndc (product): 0270-5264

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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0270-5264	MultiHance	gadobenate dimeglumine	BRACCO DIAGNOSTICS INC	NDA	Current
0270-5264	MultiHance	gadobenate dimeglumine	BRACCO DIAGNOSTICS INC	NDA	Current
0270-5264	MultiHance	gadobenate dimeglumine	BRACCO DIAGNOSTICS INC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81497	SUPPL	2025-03-07
81496	SUPPL	2025-03-07
81451	SUPPL	2025-03-06
79419	SUPPL	2024-08-16
79407	SUPPL	2024-08-16
79204	SUPPL	2024-07-24
79188	SUPPL	2024-07-24
77354	SUPPL	2024-01-30
77337	SUPPL	2024-01-29
56864	SUPPL	2018-12-20
56437	SUPPL	2018-11-14
56309	SUPPL	2018-11-06
53904	SUPPL	2018-05-01
53902	SUPPL	2018-05-01
53833	SUPPL	2018-04-27
53831	SUPPL	2018-04-27
51869	SUPPL	2018-01-26
51342	SUPPL	2018-01-19
49781	SUPPL	2017-09-19
49770	SUPPL	2017-09-18
36750	SUPPL	2013-08-09
5160	SUPPL	2013-08-01
36749	SUPPL	2012-07-10
27582	SUPPL	2012-07-09
5159	SUPPL	2011-10-03
15285	SUPPL	2011-02-24
5158	SUPPL	2011-02-18
15284	SUPPL	2007-09-06
5157	SUPPL	2007-09-06
44118	ORIG	2006-06-09
21615	ORIG	2005-04-17
36748	ORIG	2005-01-26
27581	ORIG	2004-12-02