Application 087729

Type: ANDA
Sponsor: BAYER HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	UROVIST CYSTO	DIATRIZOATE MEGLUMINE	SOLUTION;URETERAL	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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A087729-001	UROVIST CYSTO	DIATRIZOATE MEGLUMINE	30%	SOLUTION / URETERAL			1982-09-23

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 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A087729-001	UROVIST CYSTO	30%	SOLUTION / URETERAL	1982-09-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A087729-001	UROVIST CYSTO	30%	SOLUTION / URETERAL	1982-09-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A087729-001	UROVIST CYSTO	30%	SOLUTION / URETERAL	1982-09-23	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A087729-001	UROVIST CYSTO	30%	SOLUTION / URETERAL	1982-09-23	`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 · 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.