ANDA 204051, held by Sun Pharma Global. Zoledronic Acid.
As of Nov 14, 2026, ANDA 204051 (Zoledronic Acid), held by Sun Pharma Global, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 3, 2014 | Original application | Tentative approval |
| Product | Active ingredient | Marketing |
|---|---|---|
| Zoledronic Acid4MG/100ML ยท injectable;injection | Zoledronic Acid | None (tentative approval) |
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
