Rosuvastatin Calcium
ANDA 210667, held by Sunshine. Rosuvastatin Calcium.
- First approved: Apr 1, 2020
- Review: Standard
- Supplements approved: 0
- Complete response letters: 0
Approvals and New Uses
The original application and every efficacy supplement, newest first| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 1, 2020 | Original application | Approved | None posted |
Products
4 strengths and forms| Product | Active ingredient | Marketing |
|---|---|---|
| Rosuvastatin CalciumEQ 5MG BASE · tablet;oral | Rosuvastatin Calcium | Rx |
| Rosuvastatin CalciumEQ 10MG BASE · tablet;oral | Rosuvastatin Calcium | Rx |
| Rosuvastatin CalciumEQ 20MG BASE · tablet;oral | Rosuvastatin Calcium | Rx |
| Rosuvastatin CalciumEQ 40MG BASE · tablet;oral | Rosuvastatin Calcium | Rx |
Identifiers
- Application
- ANDA 210667
- Drugs@FDA
- Overview at FDA
- Company
- Sunshine
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters