NDA 202356, held by Pfizer Labs. Docetaxel.
As of Nov 14, 2026, NDA 202356 (Docetaxel), held by Pfizer Labs, was first approved by FDA on Mar 13, 2014, with 3 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 13, 2014 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Sep 24, 2018 | Supplement 3Labeling · Standard review | Approved | |
| Nov 21, 2017 | Supplement 2Labeling · Standard review | Approved | |
| Dec 2, 2014 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Mar 13, 2014 | Original applicationNew formulation or manufacturer · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
