Rosuvastatin Calcium

ANDA 79169, held by Sun Pharm. Rosuvastatin Calcium.

First approved: Jul 19, 2016
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Jul 19, 2016	Original application	Approved	Letter

Products

4 strengths and forms

Product	Active ingredient	Marketing
Rosuvastatin CalciumEQ 5MG BASE · tablet;oral	Rosuvastatin Calcium	Discontinued
Rosuvastatin CalciumEQ 10MG BASE · tablet;oral	Rosuvastatin Calcium	Discontinued
Rosuvastatin CalciumEQ 20MG BASE · tablet;oral	Rosuvastatin Calcium	Discontinued
Rosuvastatin CalciumEQ 40MG BASE · tablet;oral	Rosuvastatin Calcium	Discontinued

All 10 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jul 16, 2026	Supplement 22Labeling · Standard review	Approved	None posted
Jan 14, 2025	Supplement 17Labeling · Standard review	Approved	None posted
Jan 14, 2025	Supplement 16Labeling · Standard review	Approved	None posted
Jul 13, 2023	Supplement 15Labeling · Standard review	Approved	None posted
Jul 13, 2023	Supplement 13Labeling · Standard review	Approved	None posted
Jul 13, 2023	Supplement 12Labeling · Standard review	Approved	None posted
Jul 13, 2023	Supplement 9Labeling · Standard review	Approved	None posted
Apr 7, 2020	Supplement 7Labeling · Standard review	Approved	None posted
Apr 7, 2020	Supplement 4Labeling · Standard review	Approved	None posted
Jul 19, 2016	Original application	Approved	Letter

Identifiers

Application: ANDA 79169
Drugs@FDA: Overview at FDA
Company: Sun Pharma

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