Application 074629

Type: ANDA
Sponsor: BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IOPAMIDOL	IOPAMIDOL	INJECTABLE;INJECTION	41%	No	No
002	IOPAMIDOL	IOPAMIDOL	INJECTABLE;INJECTION	61%	No	No
003	IOPAMIDOL	IOPAMIDOL	INJECTABLE;INJECTION	76%	No	No
004	IOPAMIDOL	IOPAMIDOL	INJECTABLE;INJECTION	51%	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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	Approval date
A074629-001	IOPAMIDOL	IOPAMIDOL	41%	INJECTABLE / INJECTION	1996-11-06
A074629-002	IOPAMIDOL	IOPAMIDOL	61%	INJECTABLE / INJECTION	1996-11-06
A074629-003	IOPAMIDOL	IOPAMIDOL	76%	INJECTABLE / INJECTION	1996-11-06
A074629-004	IOPAMIDOL	IOPAMIDOL	51%	INJECTABLE / INJECTION	1998-03-31

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 3 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A074629-001	IOPAMIDOL	41%	INJECTABLE / INJECTION	1996-11-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074629-002	IOPAMIDOL	61%	INJECTABLE / INJECTION	1996-11-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074629-003	IOPAMIDOL	76%	INJECTABLE / INJECTION	1996-11-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074629-004	IOPAMIDOL	51%	INJECTABLE / INJECTION	1998-03-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074629-001	IOPAMIDOL	41%	INJECTABLE / INJECTION	1996-11-06	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074629-002	IOPAMIDOL	61%	INJECTABLE / INJECTION	1996-11-06	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074629-003	IOPAMIDOL	76%	INJECTABLE / INJECTION	1996-11-06	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074629-004	IOPAMIDOL	51%	INJECTABLE / INJECTION	1998-03-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074629-001	IOPAMIDOL	41%	INJECTABLE / INJECTION	1996-11-06	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A074629-002	IOPAMIDOL	61%	INJECTABLE / INJECTION	1996-11-06	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A074629-003	IOPAMIDOL	76%	INJECTABLE / INJECTION	1996-11-06	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A074629-004	IOPAMIDOL	51%	INJECTABLE / INJECTION	1998-03-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074629-001	IOPAMIDOL	41%	INJECTABLE / INJECTION	1996-11-06	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074629-002	IOPAMIDOL	61%	INJECTABLE / INJECTION	1996-11-06	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074629-003	IOPAMIDOL	76%	INJECTABLE / INJECTION	1996-11-06	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074629-004	IOPAMIDOL	51%	INJECTABLE / INJECTION	1998-03-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074629-001	IOPAMIDOL	41%	INJECTABLE / INJECTION	1996-11-06	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A074629-002	IOPAMIDOL	61%	INJECTABLE / INJECTION	1996-11-06	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A074629-003	IOPAMIDOL	76%	INJECTABLE / INJECTION	1996-11-06	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A074629-004	IOPAMIDOL	51%	INJECTABLE / INJECTION	1998-03-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074629-001	IOPAMIDOL	41%	INJECTABLE / INJECTION	1996-11-06	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A074629-002	IOPAMIDOL	61%	INJECTABLE / INJECTION	1996-11-06	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A074629-003	IOPAMIDOL	76%	INJECTABLE / INJECTION	1996-11-06	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A074629-004	IOPAMIDOL	51%	INJECTABLE / INJECTION	1998-03-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074629-001	IOPAMIDOL	41%	INJECTABLE / INJECTION	1996-11-06	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A074629-002	IOPAMIDOL	61%	INJECTABLE / INJECTION	1996-11-06	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A074629-003	IOPAMIDOL	76%	INJECTABLE / INJECTION	1996-11-06	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A074629-004	IOPAMIDOL	51%	INJECTABLE / INJECTION	1998-03-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074629-001	IOPAMIDOL	41%	INJECTABLE / INJECTION	1996-11-06	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A074629-002	IOPAMIDOL	61%	INJECTABLE / INJECTION	1996-11-06	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A074629-003	IOPAMIDOL	76%	INJECTABLE / INJECTION	1996-11-06	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A074629-004	IOPAMIDOL	51%	INJECTABLE / INJECTION	1998-03-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074629-001	IOPAMIDOL	41%	INJECTABLE / INJECTION	1996-11-06	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A074629-002	IOPAMIDOL	61%	INJECTABLE / INJECTION	1996-11-06	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A074629-003	IOPAMIDOL	76%	INJECTABLE / INJECTION	1996-11-06	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A074629-004	IOPAMIDOL	51%	INJECTABLE / INJECTION	1998-03-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074629-001	IOPAMIDOL	41%	INJECTABLE / INJECTION	1996-11-06	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A074629-002	IOPAMIDOL	61%	INJECTABLE / INJECTION	1996-11-06	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A074629-003	IOPAMIDOL	76%	INJECTABLE / INJECTION	1996-11-06	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A074629-004	IOPAMIDOL	51%	INJECTABLE / INJECTION	1998-03-31	`ea99ee380514…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
iopamidol	IOPAMIDOL	Slate Run Pharmaceuticals, LLC	0b9e0d24-c6ca-4e22-9422-936e9d475eaa	2026-07-23	Warnings, Adverse reactions	Name fallback brand name: iopamidol generic name: IOPAMIDOL
ISOVUE 200	IOPAMIDOL	BRACCO DIAGNOSTICS INC	ae8c18c9-3e7d-4515-b980-120025a88fc1	2026-03-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IOPAMIDOL
ISOVUE 300	IOPAMIDOL	Bracco Diagnostics Inc	797a11d7-dcd4-43ff-311b-3b48a10da2f2	2026-02-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IOPAMIDOL
ISOVUE-M	IOPAMIDOL	Bracco Diagnostics Inc	11e893d2-0183-4581-b908-c8b7302c7edb	2026-02-10	Warnings, Adverse reactions	Name fallback generic name: IOPAMIDOL
iopamidol	IOPAMIDOL	Slate Run Pharmaceuticals, LLC	69e9ab05-88f8-45f9-8bc1-ed33ab1385f0	2025-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: iopamidol generic name: IOPAMIDOL

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
22347	ORIG	1997-11-07