Application 020327

Type: NDA
Sponsor: BRACCO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ISOVUE-200	IOPAMIDOL	INJECTABLE;INJECTION	41%	No	No
002	ISOVUE-250	IOPAMIDOL	INJECTABLE;INJECTION	51%	Yes	Yes
003	ISOVUE-300	IOPAMIDOL	INJECTABLE;INJECTION	61%	Yes	Yes
004	ISOVUE-370	IOPAMIDOL	INJECTABLE;INJECTION	76%	Yes	Yes

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

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
N020327-001	ISOVUE-200	IOPAMIDOL	41%	INJECTABLE / INJECTION		1994-10-12
N020327-002	ISOVUE-250	IOPAMIDOL	51%	INJECTABLE / INJECTION	RLD	1994-10-12
N020327-003	ISOVUE-300	IOPAMIDOL	61%	INJECTABLE / INJECTION	RLD, RS	1994-10-12
N020327-004	ISOVUE-370	IOPAMIDOL	76%	INJECTABLE / INJECTION	RLD, RS	1994-10-12

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 · 164 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	N020327-001	ISOVUE-200	41%	INJECTABLE / INJECTION		1994-10-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020327-002	ISOVUE-250	51%	INJECTABLE / INJECTION	RLD	1994-10-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020327-003	ISOVUE-300	61%	INJECTABLE / INJECTION	RLD, RS	1994-10-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020327-004	ISOVUE-370	76%	INJECTABLE / INJECTION	RLD, RS	1994-10-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020327-001	ISOVUE-200	41%	INJECTABLE / INJECTION		1994-10-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020327-002	ISOVUE-250	51%	INJECTABLE / INJECTION	RLD	1994-10-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020327-003	ISOVUE-300	61%	INJECTABLE / INJECTION	RLD, RS	1994-10-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020327-004	ISOVUE-370	76%	INJECTABLE / INJECTION	RLD, RS	1994-10-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020327-001	ISOVUE-200	41%	INJECTABLE / INJECTION		1994-10-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020327-002	ISOVUE-250	51%	INJECTABLE / INJECTION	RLD	1994-10-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020327-003	ISOVUE-300	61%	INJECTABLE / INJECTION	RLD, RS	1994-10-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020327-004	ISOVUE-370	76%	INJECTABLE / INJECTION	RLD, RS	1994-10-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020327-001	ISOVUE-200	41%	INJECTABLE / INJECTION		1994-10-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020327-002	ISOVUE-250	51%	INJECTABLE / INJECTION	RLD	1994-10-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020327-003	ISOVUE-300	61%	INJECTABLE / INJECTION	RLD, RS	1994-10-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020327-004	ISOVUE-370	76%	INJECTABLE / INJECTION	RLD, RS	1994-10-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020327-001	ISOVUE-200	41%	INJECTABLE / INJECTION		1994-10-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020327-002	ISOVUE-250	51%	INJECTABLE / INJECTION	RLD	1994-10-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020327-003	ISOVUE-300	61%	INJECTABLE / INJECTION	RLD, RS	1994-10-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020327-004	ISOVUE-370	76%	INJECTABLE / INJECTION	RLD, RS	1994-10-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020327-001	ISOVUE-200	41%	INJECTABLE / INJECTION		1994-10-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020327-002	ISOVUE-250	51%	INJECTABLE / INJECTION	RLD	1994-10-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020327-003	ISOVUE-300	61%	INJECTABLE / INJECTION	RLD, RS	1994-10-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020327-004	ISOVUE-370	76%	INJECTABLE / INJECTION	RLD, RS	1994-10-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020327-001	ISOVUE-200	41%	INJECTABLE / INJECTION		1994-10-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020327-002	ISOVUE-250	51%	INJECTABLE / INJECTION	RLD	1994-10-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020327-003	ISOVUE-300	61%	INJECTABLE / INJECTION	RLD, RS	1994-10-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020327-004	ISOVUE-370	76%	INJECTABLE / INJECTION	RLD, RS	1994-10-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020327-001	ISOVUE-200	41%	INJECTABLE / INJECTION		1994-10-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020327-002	ISOVUE-250	51%	INJECTABLE / INJECTION	RLD	1994-10-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020327-003	ISOVUE-300	61%	INJECTABLE / INJECTION	RLD, RS	1994-10-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020327-004	ISOVUE-370	76%	INJECTABLE / INJECTION	RLD, RS	1994-10-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020327-001	ISOVUE-200	41%	INJECTABLE / INJECTION		1994-10-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020327-002	ISOVUE-250	51%	INJECTABLE / INJECTION	RLD	1994-10-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020327-003	ISOVUE-300	61%	INJECTABLE / INJECTION	RLD, RS	1994-10-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020327-004	ISOVUE-370	76%	INJECTABLE / INJECTION	RLD, RS	1994-10-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020327-001	ISOVUE-200	41%	INJECTABLE / INJECTION		1994-10-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020327-002	ISOVUE-250	51%	INJECTABLE / INJECTION	RLD	1994-10-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020327-003	ISOVUE-300	61%	INJECTABLE / INJECTION	RLD, RS	1994-10-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020327-004	ISOVUE-370	76%	INJECTABLE / INJECTION	RLD, RS	1994-10-12	`d06236e962d9…`

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
ISOVUE 200	IOPAMIDOL	BRACCO DIAGNOSTICS INC	ae8c18c9-3e7d-4515-b980-120025a88fc1	2026-03-10	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc (product): 0270-1317 ndc (product): 0270-1315 ndc (product): 0270-1316
ISOVUE 300	IOPAMIDOL	Bracco Diagnostics Inc	797a11d7-dcd4-43ff-311b-3b48a10da2f2	2026-02-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020327 application number: NDA020327 ndc (product): 0270-1315 ndc (product): 0270-1316

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 27 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0270-1315	ISOVUE	IOPAMIDOL	Bracco Diagnostics Inc	NDA	Current
0270-1315	ISOVUE	IOPAMIDOL	Bracco Diagnostics Inc	NDA	Current
0270-1315	ISOVUE	IOPAMIDOL	Bracco Diagnostics Inc	NDA	Current
0270-1315	ISOVUE	IOPAMIDOL	Bracco Diagnostics Inc	NDA	Current
0270-1315	ISOVUE	IOPAMIDOL	Bracco Diagnostics Inc	NDA	Current
0270-1315	ISOVUE	IOPAMIDOL	Bracco Diagnostics Inc	NDA	Current
0270-1315	ISOVUE	IOPAMIDOL	Bracco Diagnostics Inc	NDA	Current
0270-1315	ISOVUE	IOPAMIDOL	Bracco Diagnostics Inc	NDA	Current
0270-1315	ISOVUE	IOPAMIDOL	Bracco Diagnostics Inc	NDA	Current
0270-1315	ISOVUE	IOPAMIDOL	Bracco Diagnostics Inc	NDA	Current
0270-1316	ISOVUE	IOPAMIDOL	Bracco Diagnostics Inc	NDA	Current
0270-1316	ISOVUE	IOPAMIDOL	Bracco Diagnostics Inc	NDA	Current
0270-1316	ISOVUE	IOPAMIDOL	Bracco Diagnostics Inc	NDA	Current
0270-1316	ISOVUE	IOPAMIDOL	Bracco Diagnostics Inc	NDA	Current
0270-1316	ISOVUE	IOPAMIDOL	Bracco Diagnostics Inc	NDA	Current
0270-1316	ISOVUE	IOPAMIDOL	Bracco Diagnostics Inc	NDA	Current
0270-1316	ISOVUE	IOPAMIDOL	Bracco Diagnostics Inc	NDA	Current
0270-1316	ISOVUE	IOPAMIDOL	Bracco Diagnostics Inc	NDA	Current
0270-1316	ISOVUE	IOPAMIDOL	Bracco Diagnostics Inc	NDA	Current
0270-1316	ISOVUE	IOPAMIDOL	Bracco Diagnostics Inc	NDA	Current
0270-1317	ISOVUE	IOPAMIDOL	Bracco Diagnostics Inc	NDA	Current
0270-1317	ISOVUE	IOPAMIDOL	Bracco Diagnostics Inc	NDA	Current
0270-1317	ISOVUE	IOPAMIDOL	Bracco Diagnostics Inc	NDA	Current
0270-1317	ISOVUE	IOPAMIDOL	Bracco Diagnostics Inc	NDA	Current
76381-315	ISOVUE	IOPAMIDOL	BIPSO GmbH	NDA	Current
76381-316	ISOVUE	IOPAMIDOL	BIPSO GmbH	NDA	Current
76381-317	ISOVUE	IOPAMIDOL	BIPSO GmbH	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84776	SUPPL	2026-01-20
84756	SUPPL	2026-01-15
74072	SUPPL	2023-04-27
74068	SUPPL	2023-04-26
70249	SUPPL	2022-02-24
70222	SUPPL	2022-02-22
52726	SUPPL	2018-02-26
52688	SUPPL	2018-02-22
47968	SUPPL	2017-04-12
47881	SUPPL	2017-04-06
34506	SUPPL	2016-01-26
24783	SUPPL	2016-01-25
34505	SUPPL	2015-07-09
2334	SUPPL	2015-07-09
24782	SUPPL	2014-06-24
34504	SUPPL	2014-06-23
24781	SUPPL	2012-08-03
12447	SUPPL	2012-08-02
24780	SUPPL	2003-12-11
24779	SUPPL	2003-07-23