Application 010669
- Type
- NDA
- Sponsor
- ASPEN GLOBAL INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 002 | LEUKERAN | CHLORAMBUCIL | TABLET;ORAL | 2MG | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 69784-610 | LEUKERAN | chlorambucil | Woodward Pharma Services LLC | NDA | Current |
| 69784-610 | LEUKERAN | chlorambucil | Woodward Pharma Services LLC | NDA | Current |
| 76388-635 | LEUKERAN | chlorambucil | Aspen Global Inc. | NDA | Current |
| 76388-635 | LEUKERAN | chlorambucil | Aspen Global Inc. | NDA | Current |
| 76388-635 | LEUKERAN | chlorambucil | Aspen Global Inc. | NDA | Current |
| 76388-635 | LEUKERAN | chlorambucil | Aspen Global Inc. | NDA | Current |
| 76388-635 | LEUKERAN | chlorambucil | Aspen Global Inc. | NDA | Current |