All regulations
Nonrulemaking
FDA
Open for Comments
FDA-2026-P-5994
Requests that FDA declare that Rosuvastatin Calcium Tablets, 7.5 mg, 15 mg, 25 mg, 30 mg, and 35 mg, are suitable for submission as an ANDA.
Documents
6
Comments
0
Description
OPEN
Key Dates
Comment Period OpensMay 28, 2026
Documents
| Type | Title | Status |
|---|---|---|
Other |
Keywords
CDER
Suitability Petition
Hyman, Phelps & McNamara, P.C.
declare that Rosuvastatin Calcium Tablets
are suitable for submission as an ANDA
Approved Drug Products with
Therapeutic Equivalence Evaluations
Orange Book
Data from Regulations.gov