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Rosuvastatin Calcium

ANDA 79145, held by Apotex. Rosuvastatin Calcium.

  • First approved: Jul 19, 2016
  • Supplements approved: 7
  • Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 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 8 submissions, including labeling and manufacturing supplements
DateSubmissionStatusDocuments
Jul 17, 2026Supplement 12Labeling · Standard reviewApprovedNone posted
Oct 25, 2024Supplement 11Labeling · Standard reviewApprovedNone posted
Nov 22, 2023Supplement 7Labeling · Standard reviewApprovedNone posted
Nov 22, 2023Supplement 8Labeling · Standard reviewApprovedNone posted
Nov 22, 2023Supplement 9Labeling · Standard reviewApprovedNone posted
Mar 9, 2020Supplement 3Labeling · Standard reviewApprovedNone posted
Mar 9, 2020Supplement 6Labeling · Standard reviewApprovedNone posted
Jul 19, 2016Original applicationApprovedLetter

Identifiers

Application
ANDA 79145
Company
Apotex

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.