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Rosuvastatin Calcium

ANDA 79166, held by Teva Pharms USA. Rosuvastatin Calcium.

  • First approved: Jul 19, 2016
  • Supplements approved: 3
  • Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below
DateSubmissionStatusDocuments
Jul 19, 2016Original applicationApprovedLetterLetter

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 4 submissions, including labeling and manufacturing supplements
DateSubmissionStatusDocuments
Dec 16, 2024Supplement 1Labeling · Standard reviewApprovedNone posted
Dec 16, 2024Supplement 2Labeling · Standard reviewApprovedNone posted
Dec 16, 2024Supplement 5Labeling · Standard reviewApprovedNone posted
Jul 19, 2016Original applicationApprovedLetterLetter

Identifiers

Application
ANDA 79166

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.