ANDA 215975, held by Msn Labs Pvt Ltd. Letrozole;Ribociclib Succinate.
As of Nov 15, 2026, ANDA 215975 (Letrozole;Vribociclib Succinate), held by Msn Labs Pvt Ltd, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 1, 2023 | Original application | Tentative approval | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Letrozole;Vribociclib Succinate200MG;2.5MG ยท tablet;oral | Letrozole;Ribociclib Succinate | 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
