Application 213871
- Type
- NDA
- Sponsor
- PFIZER INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CIBINQO | ABROCITINIB | TABLET;ORAL | 50MG | Yes | No |
| 002 | CIBINQO | ABROCITINIB | TABLET;ORAL | 100MG | Yes | No |
| 003 | CIBINQO | ABROCITINIB | TABLET; ORAL | 200MG | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0069-0235 | Cibinqo | abrocitinib | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0335 | Cibinqo | abrocitinib | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-0435 | Cibinqo | abrocitinib | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 63539-236 | CIBINQO | abrocitinib | U.S. Pharmaceuticals | NDA | Current |
| 63539-336 | CIBINQO | abrocitinib | U.S. Pharmaceuticals | NDA | Current |
| 63539-436 | CIBINQO | abrocitinib | U.S. Pharmaceuticals | NDA | Current |