Application 205383

Type: NDA
Sponsor: INTERPHARMA PRAHA AS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ORALTAG	IOHEXOL	FOR SOLUTION;ORAL	9.7GM/BOT	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N205383-001	ORALTAG	IOHEXOL	9.7GM/BOT	FOR SOLUTION / ORAL			2015-03-26

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N205383-001	ORALTAG	9.7GM/BOT	FOR SOLUTION / ORAL	2015-03-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N205383-001	ORALTAG	9.7GM/BOT	FOR SOLUTION / ORAL	2015-03-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N205383-001	ORALTAG	9.7GM/BOT	FOR SOLUTION / ORAL	2015-03-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205383-001	ORALTAG	9.7GM/BOT	FOR SOLUTION / ORAL	2015-03-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205383-001	ORALTAG	9.7GM/BOT	FOR SOLUTION / ORAL	2015-03-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205383-001	ORALTAG	9.7GM/BOT	FOR SOLUTION / ORAL	2015-03-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205383-001	ORALTAG	9.7GM/BOT	FOR SOLUTION / ORAL	2015-03-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205383-001	ORALTAG	9.7GM/BOT	FOR SOLUTION / ORAL	2015-03-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205383-001	ORALTAG	9.7GM/BOT	FOR SOLUTION / ORAL	2015-03-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205383-001	ORALTAG	9.7GM/BOT	FOR SOLUTION / ORAL	2015-03-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205383-001	ORALTAG	9.7GM/BOT	FOR SOLUTION / ORAL	2015-03-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205383-001	ORALTAG	9.7GM/BOT	FOR SOLUTION / ORAL	2015-03-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205383-001	ORALTAG	9.7GM/BOT	FOR SOLUTION / ORAL	2015-03-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205383-001	ORALTAG	9.7GM/BOT	FOR SOLUTION / ORAL	2015-03-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205383-001	ORALTAG	9.7GM/BOT	FOR SOLUTION / ORAL	2015-03-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N205383-001	ORALTAG	9.7GM/BOT	FOR SOLUTION / ORAL	2015-03-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205383-001	ORALTAG	9.7GM/BOT	FOR SOLUTION / ORAL	2015-03-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N205383-001	ORALTAG	9.7GM/BOT	FOR SOLUTION / ORAL	2015-03-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N205383-001	ORALTAG	9.7GM/BOT	FOR SOLUTION / ORAL	2015-03-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N205383-001	ORALTAG	9.7GM/BOT	FOR SOLUTION / ORAL	2015-03-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N205383-001	ORALTAG	9.7GM/BOT	FOR SOLUTION / ORAL	2015-03-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N205383-001	ORALTAG	9.7GM/BOT	FOR SOLUTION / ORAL	2015-03-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N205383-001	ORALTAG	9.7GM/BOT	FOR SOLUTION / ORAL	2015-03-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N205383-001	ORALTAG	9.7GM/BOT	FOR SOLUTION / ORAL	2015-03-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N205383-001	ORALTAG	9.7GM/BOT	FOR SOLUTION / ORAL	2015-03-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N205383-001	ORALTAG	9.7GM/BOT	FOR SOLUTION / ORAL	2015-03-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N205383-001	ORALTAG	9.7GM/BOT	FOR SOLUTION / ORAL	2015-03-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N205383-001	ORALTAG	9.7GM/BOT	FOR SOLUTION / ORAL	2015-03-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N205383-001	ORALTAG	9.7GM/BOT	FOR SOLUTION / ORAL	2015-03-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N205383-001	ORALTAG	9.7GM/BOT	FOR SOLUTION / ORAL	2015-03-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N205383-001	ORALTAG	9.7GM/BOT	FOR SOLUTION / ORAL	2015-03-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N205383-001	ORALTAG	9.7GM/BOT	FOR SOLUTION / ORAL	2015-03-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N205383-001	ORALTAG	9.7GM/BOT	FOR SOLUTION / ORAL	2015-03-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N205383-001	ORALTAG	9.7GM/BOT	FOR SOLUTION / ORAL	2015-03-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N205383-001	ORALTAG	9.7GM/BOT	FOR SOLUTION / ORAL	2015-03-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N205383-001	ORALTAG	9.7GM/BOT	FOR SOLUTION / ORAL	2015-03-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N205383-001	ORALTAG	9.7GM/BOT	FOR SOLUTION / ORAL	2015-03-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N205383-001	ORALTAG	9.7GM/BOT	FOR SOLUTION / ORAL	2015-03-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N205383-001	ORALTAG	9.7GM/BOT	FOR SOLUTION / ORAL	2015-03-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N205383-001	ORALTAG	9.7GM/BOT	FOR SOLUTION / ORAL	2015-03-26	`f41ea6bd6efb…`

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
Iohexol	IOHEXOL	Amneal Pharmaceuticals Private Limited	ff9456ef-c45a-450d-9004-a684af2bcc59	2026-06-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IOHEXOL
OMNIPAQUE	IOHEXOL	Medical Purchasing Solutions, LLC	5088be1d-a708-1cac-e063-6394a90a2aff	2026-04-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IOHEXOL
OMNIPAQUE	IOHEXOL	Medical Purchasing Solutions, LLC	508c42eb-f5e5-44f1-e063-6294a90a4d1f	2026-04-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IOHEXOL
OMNIPAQUE	IOHEXOL	GE Healthcare Inc.	eee15ebe-d349-4497-acef-6abe7a8247fb	2026-04-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IOHEXOL
Omnipaque	IOHEXOL	GE Healthcare	164b27b9-97ae-4279-896f-1c4afa583dd1	2026-04-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IOHEXOL

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
54702-501	ORALTAG	Iohexol	Interpharma Praha, a.s.	NDA	Current
54702-501	ORALTAG	Iohexol	Interpharma Praha, a.s.	NDA	Current
54702-501	ORALTAG	Iohexol	Interpharma Praha, a.s.	NDA	Current
54702-501	ORALTAG	Iohexol	Interpharma Praha, a.s.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
19639	ORIG	2015-04-28
24492	ORIG	2015-04-22
22985	ORIG	2015-04-22
10441	ORIG	2015-04-03
51206	ORIG	1900-01-01
51204	ORIG	1900-01-01
51203	ORIG	1900-01-01