Application 018735

Type: NDA
Sponsor: BRACCO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ISOVUE-M 200	IOPAMIDOL	INJECTABLE;INJECTION	41%	Yes	Yes
002	ISOVUE-300	IOPAMIDOL	INJECTABLE;INJECTION	61%	Yes	Yes
003	ISOVUE-370	IOPAMIDOL	INJECTABLE;INJECTION	76%	Yes	Yes
004	ISOVUE-M 300	IOPAMIDOL	INJECTABLE;INJECTION	61%	Yes	Yes
005	ISOVUE-128	IOPAMIDOL	INJECTABLE;INJECTION	26%	No	No
006	ISOVUE-200	IOPAMIDOL	INJECTABLE;INJECTION	41%	Yes	Yes
007	ISOVUE-250	IOPAMIDOL	INJECTABLE;INJECTION	51%	Yes	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N018735-001	ISOVUE-M 200	IOPAMIDOL	41%	INJECTABLE / INJECTION	AP1	RLD, RS	1985-12-31
N018735-002	ISOVUE-300	IOPAMIDOL	61%	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-31
N018735-003	ISOVUE-370	IOPAMIDOL	76%	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-31
N018735-004	ISOVUE-M 300	IOPAMIDOL	61%	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-31
N018735-005	ISOVUE-128	IOPAMIDOL	26%	INJECTABLE / INJECTION			1986-10-21
N018735-006	ISOVUE-200	IOPAMIDOL	41%	INJECTABLE / INJECTION	AP2	RLD, RS	1987-07-07
N018735-007	ISOVUE-250	IOPAMIDOL	51%	INJECTABLE / INJECTION	AP	RLD, RS	1992-07-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
N018735-001	AP1
N018735-002	AP
N018735-003	AP
N018735-004	AP
N018735-006	AP2
N018735-007	AP

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N018735-002	I-975	2028-10-10
N018735-003	I-975	2028-10-10
N018735-006	I-975	2028-10-10
N018735-007	I-975	2028-10-10

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 8 · 287 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N018735-001	ISOVUE-M 200	41%	INJECTABLE / INJECTION	AP1	RLD, RS	1985-12-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018735-002	ISOVUE-300	61%	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018735-003	ISOVUE-370	76%	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018735-004	ISOVUE-M 300	61%	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018735-005	ISOVUE-128	26%	INJECTABLE / INJECTION			1986-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018735-006	ISOVUE-200	41%	INJECTABLE / INJECTION	AP2	RLD, RS	1987-07-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018735-007	ISOVUE-250	51%	INJECTABLE / INJECTION	AP	RLD, RS	1992-07-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018735-001	ISOVUE-M 200	41%	INJECTABLE / INJECTION	AP1	RLD, RS	1985-12-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018735-002	ISOVUE-300	61%	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018735-003	ISOVUE-370	76%	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018735-004	ISOVUE-M 300	61%	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018735-005	ISOVUE-128	26%	INJECTABLE / INJECTION			1986-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018735-006	ISOVUE-200	41%	INJECTABLE / INJECTION	AP2	RLD, RS	1987-07-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018735-007	ISOVUE-250	51%	INJECTABLE / INJECTION	AP	RLD, RS	1992-07-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018735-001	ISOVUE-M 200	41%	INJECTABLE / INJECTION	AP1	RLD, RS	1985-12-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018735-002	ISOVUE-300	61%	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018735-003	ISOVUE-370	76%	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018735-004	ISOVUE-M 300	61%	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018735-005	ISOVUE-128	26%	INJECTABLE / INJECTION			1986-10-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018735-006	ISOVUE-200	41%	INJECTABLE / INJECTION	AP2	RLD, RS	1987-07-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018735-007	ISOVUE-250	51%	INJECTABLE / INJECTION	AP	RLD, RS	1992-07-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018735-001	ISOVUE-M 200	41%	INJECTABLE / INJECTION	AP1	RLD, RS	1985-12-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018735-002	ISOVUE-300	61%	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018735-003	ISOVUE-370	76%	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018735-004	ISOVUE-M 300	61%	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018735-005	ISOVUE-128	26%	INJECTABLE / INJECTION			1986-10-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018735-006	ISOVUE-200	41%	INJECTABLE / INJECTION	AP2	RLD, RS	1987-07-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018735-007	ISOVUE-250	51%	INJECTABLE / INJECTION	AP	RLD, RS	1992-07-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018735-001	ISOVUE-M 200	41%	INJECTABLE / INJECTION	AP1	RLD, RS	1985-12-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018735-002	ISOVUE-300	61%	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018735-003	ISOVUE-370	76%	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018735-004	ISOVUE-M 300	61%	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018735-005	ISOVUE-128	26%	INJECTABLE / INJECTION			1986-10-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018735-006	ISOVUE-200	41%	INJECTABLE / INJECTION	AP2	RLD, RS	1987-07-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018735-007	ISOVUE-250	51%	INJECTABLE / INJECTION	AP	RLD, RS	1992-07-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018735-001	ISOVUE-M 200	41%	INJECTABLE / INJECTION	AP1	RLD, RS	1985-12-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018735-002	ISOVUE-300	61%	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018735-003	ISOVUE-370	76%	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018735-004	ISOVUE-M 300	61%	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018735-005	ISOVUE-128	26%	INJECTABLE / INJECTION			1986-10-21	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N018735-001	AP1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018735-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018735-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018735-004	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018735-006	AP2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018735-007	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018735-001	AP1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018735-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018735-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018735-004	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018735-006	AP2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018735-007	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018735-001	AP1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018735-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018735-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018735-004	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018735-006	AP2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018735-007	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018735-001	AP1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018735-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018735-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018735-004	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018735-006	AP2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018735-007	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018735-001	AP1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018735-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018735-003	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018735-004	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018735-006	AP2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018735-007	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018735-001	AP1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018735-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018735-003	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018735-004	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018735-006	AP2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018735-007	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018735-001	AP1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018735-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018735-003	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018735-004	AP	1	`2680178bc6a6…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N018735-002	I-975	2028-10-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018735-003	I-975	2028-10-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018735-006	I-975	2028-10-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018735-007	I-975	2028-10-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018735-002	I-975	2028-10-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018735-003	I-975	2028-10-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018735-006	I-975	2028-10-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018735-007	I-975	2028-10-10	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N018735-002	I-975	2028-10-10	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N018735-003	I-975	2028-10-10	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N018735-006	I-975	2028-10-10	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N018735-007	I-975	2028-10-10	`a50c72e98297…`

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 · 3 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 application applno (NDA): 018735 application number: NDA018735 ndc (product): 0270-1314 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 ndc (product): 0270-1315 ndc (product): 0270-1316
ISOVUE-M	IOPAMIDOL	Bracco Diagnostics Inc	11e893d2-0183-4581-b908-c8b7302c7edb	2026-02-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018735 application number: NDA018735 ndc (product): 0270-1411 ndc (product): 0270-1412

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 43 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0270-1314	ISOVUE	IOPAMIDOL	BRACCO DIAGNOSTICS INC	NDA	Current
0270-1314	ISOVUE	IOPAMIDOL	BRACCO DIAGNOSTICS INC	NDA	Current
0270-1314	ISOVUE	IOPAMIDOL	BRACCO DIAGNOSTICS INC	NDA	Current
0270-1314	ISOVUE	IOPAMIDOL	BRACCO DIAGNOSTICS INC	NDA	Current
0270-1314	ISOVUE	IOPAMIDOL	BRACCO DIAGNOSTICS INC	NDA	Current
0270-1314	ISOVUE	IOPAMIDOL	BRACCO DIAGNOSTICS INC	NDA	Current
0270-1314	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
0270-1317	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
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
0270-1411	ISOVUE-M	IOPAMIDOL	Bracco Diagnostics Inc	NDA	Current
0270-1411	ISOVUE-M	IOPAMIDOL	Bracco Diagnostics Inc	NDA	Current
0270-1411	ISOVUE-M	IOPAMIDOL	Bracco Diagnostics Inc	NDA	Current
0270-1411	ISOVUE-M	IOPAMIDOL	Bracco Diagnostics Inc	NDA	Current
0270-1412	ISOVUE-M	IOPAMIDOL	Bracco Diagnostics Inc	NDA	Current
0270-1412	ISOVUE-M	IOPAMIDOL	Bracco Diagnostics Inc	NDA	Current
0270-1412	ISOVUE-M	IOPAMIDOL	Bracco Diagnostics Inc	NDA	Current
0270-1412	ISOVUE-M	IOPAMIDOL	Bracco Diagnostics Inc	NDA	Current
52584-411	ISOVUE-M 200	Iopamidol	General Injectables & Vaccines, Inc.	NDA	Current
76381-314	ISOVUE	IOPAMIDOL	BIPSO GmbH	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
76381-411	ISOVUE-M	IOPAMIDOL	BIPSO GmbH	NDA	Current
76381-412	ISOVUE-M	IOPAMIDOL	BIPSO GmbH	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84775	SUPPL	2026-01-20
84755	SUPPL	2026-01-15
83769	SUPPL	2025-10-15
83768	SUPPL	2025-10-15
83752	SUPPL	2025-10-15
83751	SUPPL	2025-10-15
80542	SUPPL	2024-12-10
80536	SUPPL	2024-12-09
74071	SUPPL	2023-04-27
74067	SUPPL	2023-04-26
70250	SUPPL	2022-02-24
70221	SUPPL	2022-02-22
47969	SUPPL	2017-04-12
47882	SUPPL	2017-04-06
33586	SUPPL	2015-07-09
16020	SUPPL	2015-07-09
16019	SUPPL	2012-08-03
33585	SUPPL	2012-08-02
16018	SUPPL	2002-07-08
1057	SUPPL	2002-06-20