NDA 202172, held by Watson Labs Inc. Rosuvastatin Zinc.
As of Nov 13, 2026, NDA 202172 (Rosuvastatin Zinc), held by Watson Labs Inc, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 12, 2016 | Original applicationNew active ingredient · Standard review | Tentative approval |
| Rosuvastatin Zinc5MG · tablet; oral | Rosuvastatin Zinc | None (tentative approval) |
| Rosuvastatin Zinc10MG · tablet; oral | Rosuvastatin Zinc | None (tentative approval) |
| Rosuvastatin Zinc20MG · tablet; oral | Rosuvastatin Zinc | None (tentative approval) |
| Rosuvastatin Zinc40MG · tablet; oral | Rosuvastatin Zinc | 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
