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Rosuvastatin Calcium

ANDA 207616, held by Hetero Labs Ltd V. Rosuvastatin Calcium.

  • First approved: Oct 31, 2016
  • Review: Standard
  • Supplements approved: 6
  • Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below
DateSubmissionStatusDocuments
Oct 31, 2016Original applicationApprovedNone posted

Products

4 strengths and forms
ProductActive ingredientMarketing
Rosuvastatin CalciumEQ 5MG BASE · tablet;oralRosuvastatin CalciumRx
Rosuvastatin CalciumEQ 10MG BASE · tablet;oralRosuvastatin CalciumRx
Rosuvastatin CalciumEQ 20MG BASE · tablet;oralRosuvastatin CalciumRx
Rosuvastatin CalciumEQ 40MG BASE · tablet;oralRosuvastatin CalciumRx
All 7 submissions, including labeling and manufacturing supplements
DateSubmissionStatusDocuments
Aug 17, 2026Supplement 27Labeling · Standard reviewApprovedNone posted
Mar 12, 2025Supplement 23Labeling · Standard reviewApprovedNone posted
Mar 12, 2024Supplement 11Labeling · Standard reviewApprovedNone posted
Mar 12, 2024Supplement 17Labeling · Standard reviewApprovedNone posted
Apr 7, 2020Supplement 1Labeling · Standard reviewApprovedNone posted
Apr 7, 2020Supplement 5Labeling · Standard reviewApprovedNone posted
Oct 31, 2016Original applicationApprovedNone posted

Identifiers

Application
ANDA 207616

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.