NDA 50762, held by Pfizer. Azithromycin Dihydrate; Trovafloxacin Mesylate.
As of Nov 13, 2026, NDA 50762 (Trovan/Zithromax Compliance Pak), held by Pfizer, was first approved by FDA on Dec 18, 1998, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 18, 1998 | Original applicationNew combination · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Trovan/Zithromax Compliance PakEQ 1GM BASE,N/A;N/A,EQ 100MG BASE · for suspension, tablet;oral | Azithromycin Dihydrate; Trovafloxacin Mesylate | Discontinued |
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
