Application 009386
- Type
- NDA
- Sponsor
- ASPEN GLOBAL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MYLERAN | BUSULFAN | TABLET;ORAL | 2MG | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 69784-620 | MYLERAN | busulfan | Woodward Pharma Services LLC | NDA | Current |
| 69784-620 | MYLERAN | busulfan | Woodward Pharma Services LLC | NDA | Current |
| 76388-713 | MYLERAN | busulfan | Aspen Global Inc. | NDA | Current |
| 76388-713 | MYLERAN | busulfan | Aspen Global Inc. | NDA | Current |
| 76388-713 | MYLERAN | busulfan | Aspen Global Inc. | NDA | Current |
| 76388-713 | MYLERAN | busulfan | Aspen Global Inc. | NDA | Current |
| 76388-713 | MYLERAN | busulfan | Aspen Global Inc. | NDA | Current |