Application 216017

Type: NDA
Sponsor: BRACCO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IOMERVU	IOMEPROL	SOLUTION;INTRAVENOUS	25GM IODINE/100ML (250MG IODINE/ML)	Yes	No
002	IOMERVU	IOMEPROL	SOLUTION;INTRAVENOUS	15GM IODINE/50ML (300MG IODINE/ML)	Yes	No
003	IOMERVU	IOMEPROL	SOLUTION;INTRAVENOUS	30GM IODINE/100ML (300MG IODINE/ML)	Yes	No
004	IOMERVU	IOMEPROL	SOLUTION;INTRAVENOUS	45GM IODINE/150ML (300MG IODINE/ML)	Yes	No
005	IOMERVU	IOMEPROL	SOLUTION;INTRAVENOUS	60GM IODINE/200ML (300MG IODINE/ML)	Yes	No
006	IOMERVU	IOMEPROL	SOLUTION;INTRAVENOUS	17.5GM IODINE/50ML (350MG IODINE/ML)	Yes	No
007	IOMERVU	IOMEPROL	SOLUTION;INTRAVENOUS	35GM IODINE/100ML (350MG IODINE/ML)	Yes	Yes
008	IOMERVU	IOMEPROL	SOLUTION;INTRAVENOUS	52.5GM IODINE/150ML (350MG IODINE/ML)	Yes	No
009	IOMERVU	IOMEPROL	SOLUTION;INTRAVENOUS	70GM IODINE/200ML (350MG IODINE/ML)	Yes	Yes
010	IOMERVU	IOMEPROL	SOLUTION;INTRAVENOUS	20GM IODINE/50ML (400MG IODINE/ML)	Yes	No
011	IOMERVU	IOMEPROL	SOLUTION;INTRAVENOUS	40GM IODINE/100ML (400MG IODINE/ML)	Yes	Yes
012	IOMERVU	IOMEPROL	SOLUTION;INTRAVENOUS	60GM IODINE/150ML (400MG IODINE/ML)	Yes	No
013	IOMERVU	IOMEPROL	SOLUTION;INTRAVENOUS	80GM IODINE/200ML (400MG IODINE/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 · 13 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N216017-001	IOMERVU	IOMEPROL	25GM IODINE/100ML (250MG IODINE/ML)	SOLUTION / INTRAVENOUS	RLD	2024-11-27
N216017-002	IOMERVU	IOMEPROL	15GM IODINE/50ML (300MG IODINE/ML)	SOLUTION / INTRAVENOUS	RLD	2024-11-27
N216017-003	IOMERVU	IOMEPROL	30GM IODINE/100ML (300MG IODINE/ML)	SOLUTION / INTRAVENOUS	RLD	2024-11-27
N216017-004	IOMERVU	IOMEPROL	45GM IODINE/150ML (300MG IODINE/ML)	SOLUTION / INTRAVENOUS	RLD	2024-11-27
N216017-005	IOMERVU	IOMEPROL	60GM IODINE/200ML (300MG IODINE/ML)	SOLUTION / INTRAVENOUS	RLD	2024-11-27
N216017-006	IOMERVU	IOMEPROL	17.5GM IODINE/50ML (350MG IODINE/ML)	SOLUTION / INTRAVENOUS	RLD	2024-11-27
N216017-007	IOMERVU	IOMEPROL	35GM IODINE/100ML (350MG IODINE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-11-27
N216017-008	IOMERVU	IOMEPROL	52.5GM IODINE/150ML (350MG IODINE/ML)	SOLUTION / INTRAVENOUS	RLD	2024-11-27
N216017-009	IOMERVU	IOMEPROL	70GM IODINE/200ML (350MG IODINE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-11-27
N216017-010	IOMERVU	IOMEPROL	20GM IODINE/50ML (400MG IODINE/ML)	SOLUTION / INTRAVENOUS	RLD	2024-11-27
N216017-011	IOMERVU	IOMEPROL	40GM IODINE/100ML (400MG IODINE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-11-27
N216017-012	IOMERVU	IOMEPROL	60GM IODINE/150ML (400MG IODINE/ML)	SOLUTION / INTRAVENOUS	RLD	2024-11-27
N216017-013	IOMERVU	IOMEPROL	80GM IODINE/200ML (400MG IODINE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-11-27

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 13 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N216017-001	NCE	2029-11-27
N216017-002	NCE	2029-11-27
N216017-003	NCE	2029-11-27
N216017-004	NCE	2029-11-27
N216017-005	NCE	2029-11-27
N216017-006	NCE	2029-11-27
N216017-007	NCE	2029-11-27
N216017-008	NCE	2029-11-27
N216017-009	NCE	2029-11-27
N216017-010	NCE	2029-11-27
N216017-011	NCE	2029-11-27
N216017-012	NCE	2029-11-27
N216017-013	NCE	2029-11-27

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 4 · 130 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	N216017-001	IOMERVU	25GM IODINE/100ML (250MG IODINE/ML)	SOLUTION / INTRAVENOUS	RLD	2024-11-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216017-002	IOMERVU	15GM IODINE/50ML (300MG IODINE/ML)	SOLUTION / INTRAVENOUS	RLD	2024-11-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216017-003	IOMERVU	30GM IODINE/100ML (300MG IODINE/ML)	SOLUTION / INTRAVENOUS	RLD	2024-11-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216017-004	IOMERVU	45GM IODINE/150ML (300MG IODINE/ML)	SOLUTION / INTRAVENOUS	RLD	2024-11-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216017-005	IOMERVU	60GM IODINE/200ML (300MG IODINE/ML)	SOLUTION / INTRAVENOUS	RLD	2024-11-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216017-006	IOMERVU	17.5GM IODINE/50ML (350MG IODINE/ML)	SOLUTION / INTRAVENOUS	RLD	2024-11-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216017-007	IOMERVU	35GM IODINE/100ML (350MG IODINE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-11-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216017-008	IOMERVU	52.5GM IODINE/150ML (350MG IODINE/ML)	SOLUTION / INTRAVENOUS	RLD	2024-11-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216017-009	IOMERVU	70GM IODINE/200ML (350MG IODINE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-11-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216017-010	IOMERVU	20GM IODINE/50ML (400MG IODINE/ML)	SOLUTION / INTRAVENOUS	RLD	2024-11-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216017-011	IOMERVU	40GM IODINE/100ML (400MG IODINE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-11-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216017-012	IOMERVU	60GM IODINE/150ML (400MG IODINE/ML)	SOLUTION / INTRAVENOUS	RLD	2024-11-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216017-013	IOMERVU	80GM IODINE/200ML (400MG IODINE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-11-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N216017-001	IOMERVU	25GM IODINE/100ML (250MG IODINE/ML)	SOLUTION / INTRAVENOUS	RLD	2024-11-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216017-002	IOMERVU	15GM IODINE/50ML (300MG IODINE/ML)	SOLUTION / INTRAVENOUS	RLD	2024-11-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216017-003	IOMERVU	30GM IODINE/100ML (300MG IODINE/ML)	SOLUTION / INTRAVENOUS	RLD	2024-11-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216017-004	IOMERVU	45GM IODINE/150ML (300MG IODINE/ML)	SOLUTION / INTRAVENOUS	RLD	2024-11-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216017-005	IOMERVU	60GM IODINE/200ML (300MG IODINE/ML)	SOLUTION / INTRAVENOUS	RLD	2024-11-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216017-006	IOMERVU	17.5GM IODINE/50ML (350MG IODINE/ML)	SOLUTION / INTRAVENOUS	RLD	2024-11-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216017-007	IOMERVU	35GM IODINE/100ML (350MG IODINE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-11-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216017-008	IOMERVU	52.5GM IODINE/150ML (350MG IODINE/ML)	SOLUTION / INTRAVENOUS	RLD	2024-11-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216017-009	IOMERVU	70GM IODINE/200ML (350MG IODINE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-11-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216017-010	IOMERVU	20GM IODINE/50ML (400MG IODINE/ML)	SOLUTION / INTRAVENOUS	RLD	2024-11-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216017-011	IOMERVU	40GM IODINE/100ML (400MG IODINE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-11-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216017-012	IOMERVU	60GM IODINE/150ML (400MG IODINE/ML)	SOLUTION / INTRAVENOUS	RLD	2024-11-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216017-013	IOMERVU	80GM IODINE/200ML (400MG IODINE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-11-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N216017-001	IOMERVU	25GM IODINE/100ML (250MG IODINE/ML)	SOLUTION / INTRAVENOUS	RLD	2024-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216017-002	IOMERVU	15GM IODINE/50ML (300MG IODINE/ML)	SOLUTION / INTRAVENOUS	RLD	2024-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216017-003	IOMERVU	30GM IODINE/100ML (300MG IODINE/ML)	SOLUTION / INTRAVENOUS	RLD	2024-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216017-004	IOMERVU	45GM IODINE/150ML (300MG IODINE/ML)	SOLUTION / INTRAVENOUS	RLD	2024-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216017-005	IOMERVU	60GM IODINE/200ML (300MG IODINE/ML)	SOLUTION / INTRAVENOUS	RLD	2024-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216017-006	IOMERVU	17.5GM IODINE/50ML (350MG IODINE/ML)	SOLUTION / INTRAVENOUS	RLD	2024-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216017-007	IOMERVU	35GM IODINE/100ML (350MG IODINE/ML)	SOLUTION / INTRAVENOUS	RLD	2024-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216017-008	IOMERVU	52.5GM IODINE/150ML (350MG IODINE/ML)	SOLUTION / INTRAVENOUS	RLD	2024-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216017-009	IOMERVU	70GM IODINE/200ML (350MG IODINE/ML)	SOLUTION / INTRAVENOUS	RLD	2024-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216017-010	IOMERVU	20GM IODINE/50ML (400MG IODINE/ML)	SOLUTION / INTRAVENOUS	RLD	2024-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216017-011	IOMERVU	40GM IODINE/100ML (400MG IODINE/ML)	SOLUTION / INTRAVENOUS	RLD	2024-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216017-012	IOMERVU	60GM IODINE/150ML (400MG IODINE/ML)	SOLUTION / INTRAVENOUS	RLD	2024-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216017-013	IOMERVU	80GM IODINE/200ML (400MG IODINE/ML)	SOLUTION / INTRAVENOUS	RLD	2024-11-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216017-001	IOMERVU	25GM IODINE/100ML (250MG IODINE/ML)	SOLUTION / INTRAVENOUS	RLD	2024-11-27	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 104 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N216017-001	NCE	2029-11-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216017-002	NCE	2029-11-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216017-003	NCE	2029-11-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216017-004	NCE	2029-11-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216017-005	NCE	2029-11-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216017-006	NCE	2029-11-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216017-007	NCE	2029-11-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216017-008	NCE	2029-11-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216017-009	NCE	2029-11-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216017-010	NCE	2029-11-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216017-011	NCE	2029-11-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216017-012	NCE	2029-11-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216017-013	NCE	2029-11-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N216017-001	NCE	2029-11-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216017-002	NCE	2029-11-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216017-003	NCE	2029-11-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216017-004	NCE	2029-11-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216017-005	NCE	2029-11-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216017-006	NCE	2029-11-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216017-007	NCE	2029-11-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216017-008	NCE	2029-11-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216017-009	NCE	2029-11-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216017-010	NCE	2029-11-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216017-011	NCE	2029-11-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216017-012	NCE	2029-11-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216017-013	NCE	2029-11-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N216017-001	NCE	2029-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216017-002	NCE	2029-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216017-003	NCE	2029-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216017-004	NCE	2029-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216017-005	NCE	2029-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216017-006	NCE	2029-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216017-007	NCE	2029-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216017-008	NCE	2029-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216017-009	NCE	2029-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216017-010	NCE	2029-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216017-011	NCE	2029-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216017-012	NCE	2029-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216017-013	NCE	2029-11-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216017-001	NCE	2029-11-27	`31067a03dcf5…`

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
IOMERVU	IOMEPROL INJECTION	BRACCO DIAGNOSTICS INC	cb2e0e00-7c93-0fb4-89a5-861641662a5a	2026-02-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: IOMERVU

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80740	ORIG	2024-12-26
80453	ORIG	2024-11-29
80450	ORIG	2024-11-29