Application 017057
- Type
- NDA
- Sponsor
- LIEBEL-FLARSHEIM
Application Products#
| 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 |
NDC Listings For This Application#
| 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 |
|---|---|---|
| 535 | SUPPL | 2002-09-13 |