ANDA 91364, held by Dr Reddys Labs Ltd. Zoledronic Acid.
As of Nov 14, 2026, ANDA 91364 (Zoledronic Acid), held by Dr Reddys Labs Ltd, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 31, 2011 | Original application | Tentative approval | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Zoledronic Acid5MG/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
