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Rosuvastatin Calcium

ANDA 79171, held by Sandoz. Rosuvastatin Calcium.

  • First approved: Jul 19, 2016
  • Supplements approved: 8
  • Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below
DateSubmissionStatusDocuments
Jul 19, 2016Original applicationApprovedLetter

Products

4 strengths and forms
ProductActive ingredientMarketing
Rosuvastatin CalciumEQ 5MG BASE · tablet;oralRosuvastatin CalciumDiscontinued
Rosuvastatin CalciumEQ 10MG BASE · tablet;oralRosuvastatin CalciumDiscontinued
Rosuvastatin CalciumEQ 20MG BASE · tablet;oralRosuvastatin CalciumDiscontinued
Rosuvastatin CalciumEQ 40MG BASE · tablet;oralRosuvastatin CalciumDiscontinued
All 9 submissions, including labeling and manufacturing supplements
DateSubmissionStatusDocuments
Sep 25, 2026Supplement 16Labeling · Standard reviewApprovedNone posted
Dec 19, 2024Supplement 15Labeling · Standard reviewApprovedNone posted
Nov 22, 2023Supplement 14Labeling · Standard reviewApprovedNone posted
Jul 13, 2023Supplement 13Labeling · Standard reviewApprovedNone posted
Jul 13, 2023Supplement 7Labeling · Standard reviewApprovedNone posted
Jul 13, 2023Supplement 6Labeling · Standard reviewApprovedNone posted
Mar 9, 2020Supplement 5Labeling · Standard reviewApprovedNone posted
Mar 9, 2020Supplement 2Labeling · Standard reviewApprovedNone posted
Jul 19, 2016Original applicationApprovedLetter

Identifiers

Application
ANDA 79171
Company
Sandoz

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

Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.