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Rosuvastatin Calcium

ANDA 208850, held by Amneal Pharms Co. Rosuvastatin Calcium.

  • First approved: Oct 16, 2018
  • 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
Oct 16, 2018Original 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 6 submissions, including labeling and manufacturing supplements
DateSubmissionStatusDocuments
Nov 15, 2024Supplement 3Labeling · Standard reviewApprovedNone posted
Nov 15, 2024Supplement 4Labeling · Standard reviewApprovedNone posted
Nov 15, 2024Supplement 6Labeling · Standard reviewApprovedNone posted
Nov 15, 2024Supplement 8Labeling · Standard reviewApprovedNone posted
Apr 7, 2020Supplement 1Labeling · Standard reviewApprovedNone posted
Oct 16, 2018Original applicationApprovedLetter

Identifiers

Application
ANDA 208850

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.