Application 016403

Type: NDA
Sponsor: GE HEALTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HYPAQUE	DIATRIZOATE MEGLUMINE	INJECTABLE;INJECTION	60%	No	No
002	HYPAQUE	DIATRIZOATE MEGLUMINE	INJECTABLE;INJECTION	30%	No	No
003	HYPAQUE-CYSTO	DIATRIZOATE MEGLUMINE	SOLUTION;URETHRAL	30%	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS
N016403-001	HYPAQUE	DIATRIZOATE MEGLUMINE	60%	INJECTABLE / INJECTION	Approved before 1982
N016403-002	HYPAQUE	DIATRIZOATE MEGLUMINE	30%	INJECTABLE / INJECTION	Approved before 1982
N016403-003	HYPAQUE-CYSTO	DIATRIZOATE MEGLUMINE	30%	SOLUTION / URETHRAL	Approved before 1982

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 2 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016403-002	HYPAQUE	30%	INJECTABLE / INJECTION	Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016403-003	HYPAQUE-CYSTO	30%	SOLUTION / URETHRAL	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016403-001	HYPAQUE	60%	INJECTABLE / INJECTION	Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016403-002	HYPAQUE	30%	INJECTABLE / INJECTION	Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016403-003	HYPAQUE-CYSTO	30%	SOLUTION / URETHRAL	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016403-001	HYPAQUE	60%	INJECTABLE / INJECTION	Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016403-002	HYPAQUE	30%	INJECTABLE / INJECTION	Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016403-003	HYPAQUE-CYSTO	30%	SOLUTION / URETHRAL	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N016403-001	HYPAQUE	60%	INJECTABLE / INJECTION	Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N016403-002	HYPAQUE	30%	INJECTABLE / INJECTION	Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N016403-003	HYPAQUE-CYSTO	30%	SOLUTION / URETHRAL	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016403-001	HYPAQUE	60%	INJECTABLE / INJECTION	Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016403-002	HYPAQUE	30%	INJECTABLE / INJECTION	Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016403-003	HYPAQUE-CYSTO	30%	SOLUTION / URETHRAL	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N016403-001	HYPAQUE	60%	INJECTABLE / INJECTION	Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N016403-002	HYPAQUE	30%	INJECTABLE / INJECTION	Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N016403-003	HYPAQUE-CYSTO	30%	SOLUTION / URETHRAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N016403-001	HYPAQUE	60%	INJECTABLE / INJECTION	Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N016403-002	HYPAQUE	30%	INJECTABLE / INJECTION	Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N016403-003	HYPAQUE-CYSTO	30%	SOLUTION / URETHRAL	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N016403-001	HYPAQUE	60%	INJECTABLE / INJECTION	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N016403-002	HYPAQUE	30%	INJECTABLE / INJECTION	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N016403-003	HYPAQUE-CYSTO	30%	SOLUTION / URETHRAL	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N016403-001	HYPAQUE	60%	INJECTABLE / INJECTION	Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N016403-002	HYPAQUE	30%	INJECTABLE / INJECTION	Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N016403-003	HYPAQUE-CYSTO	30%	SOLUTION / URETHRAL	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N016403-001	HYPAQUE	60%	INJECTABLE / INJECTION	Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N016403-002	HYPAQUE	30%	INJECTABLE / INJECTION	Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N016403-003	HYPAQUE-CYSTO	30%	SOLUTION / URETHRAL	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016403-001	HYPAQUE	60%	INJECTABLE / INJECTION	Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016403-002	HYPAQUE	30%	INJECTABLE / INJECTION	Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016403-003	HYPAQUE-CYSTO	30%	SOLUTION / URETHRAL	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N016403-001	HYPAQUE	60%	INJECTABLE / INJECTION	Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N016403-002	HYPAQUE	30%	INJECTABLE / INJECTION	Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N016403-003	HYPAQUE-CYSTO	30%	SOLUTION / URETHRAL	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N016403-001	HYPAQUE	60%	INJECTABLE / INJECTION	Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N016403-002	HYPAQUE	30%	INJECTABLE / INJECTION	Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N016403-003	HYPAQUE-CYSTO	30%	SOLUTION / URETHRAL	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N016403-001	HYPAQUE	60%	INJECTABLE / INJECTION	Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N016403-002	HYPAQUE	30%	INJECTABLE / INJECTION	Approved before 1982	`c0c555d07b60…`

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
Cystografin Dilute	DIATRIZOATE MEGLUMINE	BRACCO DIAGNOSTICS INC	e56882fa-4a30-43b1-bb6b-f7d4a4101c4e	2025-11-23	Warnings, Adverse reactions	Name fallback generic name: DIATRIZOATE MEGLUMINE
Cystografin	DIATRIZOATE MEGLUMINE	BRACCO DIAGNOSTICS INC	7496d736-9f7d-4136-ad5d-b24c7803c21b	2025-11-23	Warnings, Adverse reactions	Name fallback generic name: DIATRIZOATE MEGLUMINE

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
12992	SUPPL	2002-09-30