Application 212608
- Type
- NDA
- Sponsor
- BLUEPRINT MEDICINES
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | AYVAKIT | AVAPRITINIB | TABLET;ORAL | 100MG | Yes | No |
| 002 | AYVAKIT | AVAPRITINIB | TABLET;ORAL | 200MG | Yes | No |
| 003 | AYVAKIT | AVAPRITINIB | TABLET;ORAL | 300MG | Yes | Yes |
| 004 | AYVAKIT | AVAPRITINIB | TABLET;ORAL | 25MG | Yes | No |
| 005 | AYVAKIT | AVAPRITINIB | TABLET;ORAL | 50MG | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 72064-110 | Ayvakit | avapritinib | Blueprint Medicines Corporation | NDA | Current |
| 72064-110 | Ayvakit | avapritinib | Blueprint Medicines Corporation | NDA | Current |
| 72064-110 | Ayvakit | avapritinib | Blueprint Medicines Corporation | NDA | Current |
| 72064-120 | Ayvakit | avapritinib | Blueprint Medicines Corporation | NDA | Current |
| 72064-120 | Ayvakit | avapritinib | Blueprint Medicines Corporation | NDA | Current |
| 72064-120 | Ayvakit | avapritinib | Blueprint Medicines Corporation | NDA | Current |
| 72064-125 | Ayvakit | avapritinib | Blueprint Medicines Corporation | NDA | Current |
| 72064-125 | Ayvakit | avapritinib | Blueprint Medicines Corporation | NDA | Current |
| 72064-130 | Ayvakit | avapritinib | Blueprint Medicines Corporation | NDA | Current |
| 72064-130 | Ayvakit | avapritinib | Blueprint Medicines Corporation | NDA | Current |
| 72064-130 | Ayvakit | avapritinib | Blueprint Medicines Corporation | NDA | Current |
| 72064-150 | Ayvakit | avapritinib | Blueprint Medicines Corporation | NDA | Current |
| 72064-150 | Ayvakit | avapritinib | Blueprint Medicines Corporation | NDA | Current |