Application 206430
- Type
- ANDA
- Sponsor
- CUSTOPHARM INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VALRUBICIN | VALRUBICIN | SOLUTION;INTRAVESICAL | 40MG/ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 24201-101 | Valrubicin Intravesical Solution | Valrubicin Intravesical Solution | Leucadia Pharmaceuticals | ANDA | Current |
| 24201-101 | Valrubicin Intravesical Solution | Valrubicin Intravesical Solution | Hikma Pharmaceuticals USA Inc. | ANDA | Current |