Application 211810
- Type
- NDA
- Sponsor
- DAIICHI SANKYO INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TURALIO | PEXIDARTINIB HYDROCHLORIDE | CAPSULE;ORAL | EQ 200MG BASE | Yes | Yes |
| 002 | TURALIO | PEXIDARTINIB HYDROCHLORIDE | CAPSULE;ORAL | EQ 125MG BASE | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 65597-402 | Turalio | pexidartinib | Daiichi Sankyo Inc. | NDA | Current |
| 65597-402 | Turalio | pexidartinib | Daiichi Sankyo Inc. | NDA | Current |
| 65597-402 | Turalio | pexidartinib | Daiichi Sankyo, Inc. | NDA | Current |
| 65597-402 | Turalio | pexidartinib | Daiichi Sankyo Inc. | NDA | Current |
| 65597-402 | Turalio | pexidartinib | Daiichi Sankyo, Inc. | NDA | Current |
| 65597-402 | Turalio | pexidartinib | Daiichi Sankyo Inc. | NDA | Current |