NDA 21453, held by Bristol Myers Squibb. Stavudine.
As of Nov 14, 2026, NDA 21453 (Zerit Xr), held by Bristol Myers Squibb, was first approved by FDA on Dec 31, 2002, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 31, 2002 | Original applicationNew dosage form · Standard review | Approved |
| Jan 19, 2005 | Supplement 4Labeling · Standard review | Approved | |
| Jun 4, 2004 | Supplement 3Labeling · Standard review | Approved | |
| Dec 31, 2002 | Original applicationNew dosage form · 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
