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Rosuvastatin Calcium

ANDA 205587, held by Lupin. Rosuvastatin Calcium.

  • First approved: Jul 31, 2017
  • Review: Standard
  • Supplements approved: 5
  • Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below
DateSubmissionStatusDocuments
Jul 31, 2017Original applicationApprovedNone posted

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 6 submissions, including labeling and manufacturing supplements
DateSubmissionStatusDocuments
Oct 25, 2024Supplement 5Labeling · Standard reviewApprovedNone posted
Nov 22, 2023Supplement 4Labeling · Standard reviewApprovedNone posted
Jul 13, 2023Supplement 3Labeling · Standard reviewApprovedNone posted
Mar 9, 2020Supplement 1Labeling · Standard reviewApprovedNone posted
Mar 9, 2020Supplement 2Labeling · Standard reviewApprovedNone posted
Jul 31, 2017Original applicationApprovedNone posted

Identifiers

Application
ANDA 205587
Company
Lupin

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.