NDA 20906, held by Bristol Myers Squibb. Etoposide Phosphate.
As of Nov 13, 2026, NDA 20906 (Etopophos Preservative Free), held by Bristol Myers Squibb, was first approved by FDA on Feb 27, 1998, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 27, 1998 | Original applicationNew dosage form · Standard review | Approved |
| Etopophos Preservative FreeEQ 500MG BASE/VIAL · injectable;injection | Etoposide Phosphate | Discontinued |
| Etopophos Preservative FreeEQ 1GM BASE/VIAL · injectable;injection | Etoposide Phosphate | Discontinued |
| Nov 5, 2002 | Supplement 2Labeling · Standard review | Approved | |
| Aug 16, 1999 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Feb 27, 1998 | 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
