Approvals and New Uses
The original application and every efficacy supplement, newest first; all 2 submissions below| Date | Submission | Status | Documents |
|---|
| Sep 27, 2018 | Original applicationNew molecular entity · Priority review | Approved | ReviewLabelLetter |
Products
3 strengths and forms| Product | Active ingredient | Marketing |
|---|
| Vizimpro15MG · tablet;oral | Dacomitinib | Discontinued · reference drug |
| Vizimpro30MG · tablet;oral | Dacomitinib | Discontinued · reference drug |
| Vizimpro45MG · tablet;oral | Dacomitinib | Discontinued · reference drug |
All 2 submissions, including labeling and manufacturing supplements
| Date | Submission | Status | Documents |
|---|
| Dec 18, 2020 | Supplement 3Labeling · Standard review | Approved | LabelLetter |
| Sep 27, 2018 | Original applicationNew molecular entity · Priority review | Approved | ReviewLabelLetter |
Identifiers
- Application
- NDA 211288
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
