NDA 20927, held by Novartis. Pamidronate Disodium.
As of Nov 13, 2026, NDA 20927 (Aredia), held by Novartis, was first approved by FDA on Sep 22, 1998, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 22, 1998 | Original applicationTYPE 6 · Standard review | Approved |
| Aredia30MG/VIAL · injectable; injection | Pamidronate Disodium | Rx |
| Aredia60MG/VIAL · injectable;injection | Pamidronate Disodium | Rx |
| Aredia90MG/VIAL · injectable; injection | Pamidronate Disodium | Rx |
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