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Rosuvastatin Calcium

ANDA 206603, held by Mankind Pharma. Rosuvastatin Calcium.

  • First approved: May 16, 2025
  • Review: Standard
  • Supplements approved: 1
  • Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below
DateSubmissionStatusDocuments
May 16, 2025Original 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 2 submissions, including labeling and manufacturing supplements
DateSubmissionStatusDocuments
Jul 31, 2026Supplement 2Labeling · Standard reviewApprovedNone posted
May 16, 2025Original applicationApprovedNone posted

Identifiers

Application
ANDA 206603

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.