Application 021489

Type: NDA
Sponsor: BRACCO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PROHANCE MULTIPACK	GADOTERIDOL	INJECTABLE;INJECTION	279.3MG/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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021489-001	PROHANCE MULTIPACK	GADOTERIDOL	279.3MG/ML	INJECTABLE / INJECTION		RLD, RS	2003-10-09

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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021489-001	PROHANCE MULTIPACK	279.3MG/ML	INJECTABLE / INJECTION	RLD, RS	2003-10-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021489-001	PROHANCE MULTIPACK	279.3MG/ML	INJECTABLE / INJECTION	RLD, RS	2003-10-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021489-001	PROHANCE MULTIPACK	279.3MG/ML	INJECTABLE / INJECTION	RLD, RS	2003-10-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021489-001	PROHANCE MULTIPACK	279.3MG/ML	INJECTABLE / INJECTION	RLD, RS	2003-10-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021489-001	PROHANCE MULTIPACK	279.3MG/ML	INJECTABLE / INJECTION	RLD, RS	2003-10-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021489-001	PROHANCE MULTIPACK	279.3MG/ML	INJECTABLE / INJECTION	RLD, RS	2003-10-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021489-001	PROHANCE MULTIPACK	279.3MG/ML	INJECTABLE / INJECTION	RLD, RS	2003-10-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021489-001	PROHANCE MULTIPACK	279.3MG/ML	INJECTABLE / INJECTION	RLD, RS	2003-10-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021489-001	PROHANCE MULTIPACK	279.3MG/ML	INJECTABLE / INJECTION	RLD, RS	2003-10-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021489-001	PROHANCE MULTIPACK	279.3MG/ML	INJECTABLE / INJECTION	RLD, RS	2003-10-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021489-001	PROHANCE MULTIPACK	279.3MG/ML	INJECTABLE / INJECTION	RLD, RS	2003-10-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021489-001	PROHANCE MULTIPACK	279.3MG/ML	INJECTABLE / INJECTION	RLD, RS	2003-10-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021489-001	PROHANCE MULTIPACK	279.3MG/ML	INJECTABLE / INJECTION	RLD, RS	2003-10-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021489-001	PROHANCE MULTIPACK	279.3MG/ML	INJECTABLE / INJECTION	RLD, RS	2003-10-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021489-001	PROHANCE MULTIPACK	279.3MG/ML	INJECTABLE / INJECTION	RLD, RS	2003-10-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021489-001	PROHANCE MULTIPACK	279.3MG/ML	INJECTABLE / INJECTION	RLD, RS	2003-10-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021489-001	PROHANCE MULTIPACK	279.3MG/ML	INJECTABLE / INJECTION	RLD, RS	2003-10-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021489-001	PROHANCE MULTIPACK	279.3MG/ML	INJECTABLE / INJECTION	RLD, RS	2003-10-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021489-001	PROHANCE MULTIPACK	279.3MG/ML	INJECTABLE / INJECTION	RLD, RS	2003-10-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021489-001	PROHANCE MULTIPACK	279.3MG/ML	INJECTABLE / INJECTION	RLD, RS	2003-10-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021489-001	PROHANCE MULTIPACK	279.3MG/ML	INJECTABLE / INJECTION	RLD, RS	2003-10-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021489-001	PROHANCE MULTIPACK	279.3MG/ML	INJECTABLE / INJECTION	RLD, RS	2003-10-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021489-001	PROHANCE MULTIPACK	279.3MG/ML	INJECTABLE / INJECTION	RLD, RS	2003-10-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021489-001	PROHANCE MULTIPACK	279.3MG/ML	INJECTABLE / INJECTION	RLD, RS	2003-10-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021489-001	PROHANCE MULTIPACK	279.3MG/ML	INJECTABLE / INJECTION	RLD, RS	2003-10-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021489-001	PROHANCE MULTIPACK	279.3MG/ML	INJECTABLE / INJECTION	RLD, RS	2003-10-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021489-001	PROHANCE MULTIPACK	279.3MG/ML	INJECTABLE / INJECTION	RLD, RS	2003-10-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021489-001	PROHANCE MULTIPACK	279.3MG/ML	INJECTABLE / INJECTION	RLD, RS	2003-10-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021489-001	PROHANCE MULTIPACK	279.3MG/ML	INJECTABLE / INJECTION	RLD, RS	2003-10-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021489-001	PROHANCE MULTIPACK	279.3MG/ML	INJECTABLE / INJECTION	RLD, RS	2003-10-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021489-001	PROHANCE MULTIPACK	279.3MG/ML	INJECTABLE / INJECTION	RLD, RS	2003-10-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021489-001	PROHANCE MULTIPACK	279.3MG/ML	INJECTABLE / INJECTION	RLD, RS	2003-10-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021489-001	PROHANCE MULTIPACK	279.3MG/ML	INJECTABLE / INJECTION	RLD, RS	2003-10-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021489-001	PROHANCE MULTIPACK	279.3MG/ML	INJECTABLE / INJECTION	RLD, RS	2003-10-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021489-001	PROHANCE MULTIPACK	279.3MG/ML	INJECTABLE / INJECTION	RLD, RS	2003-10-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021489-001	PROHANCE MULTIPACK	279.3MG/ML	INJECTABLE / INJECTION	RLD, RS	2003-10-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021489-001	PROHANCE MULTIPACK	279.3MG/ML	INJECTABLE / INJECTION	RLD, RS	2003-10-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021489-001	PROHANCE MULTIPACK	279.3MG/ML	INJECTABLE / INJECTION	RLD, RS	2003-10-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021489-001	PROHANCE MULTIPACK	279.3MG/ML	INJECTABLE / INJECTION	RLD, RS	2003-10-09	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021489-001	PROHANCE MULTIPACK	279.3MG/ML	INJECTABLE / INJECTION	RLD, RS	2003-10-09	`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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ProHance	GADOTERIDOL	BRACCO DIAGNOSTICS INC	778aee03-7d4c-481a-be8a-a75db0702f5a	2025-03-14	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc (product): 0270-1111
ProHance	GADOTERIDOL	Bracco Diagnostics Inc	e8b76200-c0aa-491b-aad7-e22d2f68496f	2025-03-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021489 application number: NDA021489 ndc (product): 0270-1111

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0270-1111	ProHance	gadoteridol	Bracco Diagnostics Inc	NDA	Current
0270-1111	ProHance	gadoteridol	Bracco Diagnostics Inc	NDA	Current
0270-1111	ProHance	gadoteridol	Bracco Diagnostics Inc	NDA	Current
0270-1111	ProHance	gadoteridol	Bracco Diagnostics Inc	NDA	Current
0270-1111	ProHance	gadoteridol	Bracco Diagnostics Inc	NDA	Current
0270-1111	ProHance	gadoteridol	Bracco Diagnostics Inc	NDA	Current
0270-1111	ProHance	gadoteridol	Bracco Diagnostics Inc	NDA	Current
0270-1111	ProHance	gadoteridol	Bracco Diagnostics Inc	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81533	SUPPL	2025-03-11
81449	SUPPL	2025-03-06
79421	SUPPL	2024-08-16
79404	SUPPL	2024-08-16
79403	SUPPL	2024-08-16
79202	SUPPL	2024-07-24
79192	SUPPL	2024-07-24
77343	SUPPL	2024-01-29
77334	SUPPL	2024-01-29
72674	SUPPL	2022-11-23
72671	SUPPL	2022-11-22
67473	SUPPL	2021-05-12
67443	SUPPL	2021-05-10
65739	SUPPL	2020-12-28
65738	SUPPL	2020-12-28
65670	SUPPL	2020-12-22
56435	SUPPL	2018-11-14
56311	SUPPL	2018-11-06
53895	SUPPL	2018-05-01
53846	SUPPL	2018-04-27
53845	SUPPL	2018-04-27
49780	SUPPL	2017-09-19
49774	SUPPL	2017-09-19
15591	SUPPL	2014-07-24
5530	SUPPL	2014-07-24
27922	SUPPL	2013-08-16
37061	SUPPL	2013-08-15
5529	SUPPL	2010-12-22
15590	SUPPL	2010-12-20
37060	SUPPL	2007-09-06
5528	SUPPL	2007-09-06
21689	ORIG	2006-07-25
44128	ORIG	2006-06-09
37059	ORIG	2003-10-16
5527	ORIG	2003-10-16