NDA 200732, held by Pharmobedient. Zidovudine.
As of Nov 13, 2026, NDA 200732 (Zidovudine), held by Pharmobedient, was first approved by FDA on Feb 23, 2011, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 23, 2011 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Zidovudine100MG · tablet;oral | Zidovudine | Discontinued |
| Dec 27, 2019 | Supplement 2Labeling · Standard review | Approved | |
| Nov 8, 2013 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Feb 23, 2011 | 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
