Rosuvastatin Calcium

ANDA 201619, held by Torrent. Rosuvastatin Calcium.

First approved: Oct 31, 2016
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Oct 31, 2016	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

All 11 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Nov 2, 2026	Supplement 16Labeling · Standard review	Approved	None posted
Jul 31, 2026	Supplement 15Labeling · Standard review	Approved	None posted
Nov 27, 2024	Supplement 13Labeling · Standard review	Approved	None posted
Oct 27, 2023	Supplement 11Labeling · Standard review	Approved	None posted
Jul 13, 2023	Supplement 4Labeling · Standard review	Approved	None posted
Jul 13, 2023	Supplement 5Labeling · Standard review	Approved	None posted
Jul 13, 2023	Supplement 9Labeling · Standard review	Approved	None posted
Jul 13, 2023	Supplement 10Labeling · Standard review	Approved	None posted
Mar 9, 2020	Supplement 2Labeling · Standard review	Approved	None posted
Mar 9, 2020	Supplement 3Labeling · Standard review	Approved	None posted
Oct 31, 2016	Original application	Approved	None posted

Identifiers

Application: ANDA 201619
Drugs@FDA: Overview at FDA
Company: Torrent Pharmaceuticals

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