Application 017057

Type: NDA
Sponsor: LIEBEL-FLARSHEIM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CYSTO-CONRAY	IOTHALAMATE MEGLUMINE	Solution; Intravesical, Ureteral	43%	No	No
002	CYSTO-CONRAY II	IOTHALAMATE MEGLUMINE	SOLUTION;INTRAVESICAL	17.2%	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
N017057-002	CYSTO-CONRAY II	IOTHALAMATE MEGLUMINE	17.2%	SOLUTION / INTRAVESICAL		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 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N017057-002	CYSTO-CONRAY II	17.2%	SOLUTION / INTRAVESICAL	Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N017057-002	CYSTO-CONRAY II	17.2%	SOLUTION / INTRAVESICAL	Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017057-002	CYSTO-CONRAY II	17.2%	SOLUTION / INTRAVESICAL	Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N017057-002	CYSTO-CONRAY II	17.2%	SOLUTION / INTRAVESICAL	Approved before 1982	`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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cysto-Conray II	IOTHALAMATE MEGLUMINE	Liebel-Flarsheim Company LLC	8841ab4d-674d-4beb-88a5-13e35f6005cc	2020-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 017057 application number: NDA017057 ndc (product): 0019-0862

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0019-0862	Cysto-Conray II	Iothalamate meglumine	Liebel-Flarsheim Company LLC	NDA	Current
0019-0862	Cysto-Conray II	Iothalamate meglumine	Liebel-Flarsheim Company LLC	NDA	Current
0019-0862	Cysto-Conray II	Iothalamate meglumine	Liebel-Flarsheim Company LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
535	SUPPL	2002-09-13