Documents
Application Sponsors
| NDA 017057 | LIEBEL-FLARSHEIM | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | Solution; Intravesical, Ureteral | 43% | 0 | CYSTO-CONRAY | IOTHALAMATE MEGLUMINE |
| 002 | SOLUTION;INTRAVESICAL | 17.2% | 0 | CYSTO-CONRAY II | IOTHALAMATE MEGLUMINE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1972-04-17 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1975-07-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1976-01-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1976-01-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1976-05-05 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 1976-05-05 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1976-09-14 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1976-09-14 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1978-09-06 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 1983-07-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1984-06-26 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1984-12-04 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1989-10-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1989-06-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1987-07-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1989-12-01 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1990-03-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1992-12-04 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1992-08-28 | STANDARD |
| LABELING; Labeling | SUPPL | 25 | AP | 1995-01-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 1999-10-27 | STANDARD |
| LABELING; Labeling | SUPPL | 27 | AP | 2002-09-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 2013-05-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 2013-05-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 2013-12-19 | STANDARD |
Submissions Property Types
| SUPPL | 6 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 26 | Null | 0 |
| SUPPL | 28 | Null | 0 |
| SUPPL | 29 | Null | 0 |
| SUPPL | 31 | Null | 0 |
CDER Filings
LIEBEL-FLARSHEIM
cder:Array
(
[0] => Array
(
[ApplNo] => 17057
[companyName] => LIEBEL-FLARSHEIM
[docInserts] => ["",""]
[products] => [{"drugName":"CYSTO-CONRAY","activeIngredients":"IOTHALAMATE MEGLUMINE","strength":"43%","dosageForm":"Solution; Intravesical, Ureteral","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"CYSTO-CONRAY II","activeIngredients":"IOTHALAMATE MEGLUMINE","strength":"17.2%","dosageForm":"SOLUTION;INTRAVESICAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"CYSTO-CONRAY","submission":"IOTHALAMATE MEGLUMINE","actionType":"43%","submissionClassification":"Solution; Intravesical, Ureteral","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CYSTO-CONRAY II","submission":"IOTHALAMATE MEGLUMINE","actionType":"17.2%","submissionClassification":"SOLUTION;INTRAVESICAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)