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Rosuvastatin Calcium

ANDA 206434, held by Accord Hlthcare. Rosuvastatin Calcium.

  • First approved: Oct 31, 2016
  • Review: Standard
  • Supplements approved: 8
  • Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 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 9 submissions, including labeling and manufacturing supplements
DateSubmissionStatusDocuments
Nov 2, 2026Supplement 14Labeling · Standard reviewApprovedNone posted
Jul 16, 2026Supplement 13Labeling · Standard reviewApprovedNone posted
Nov 19, 2024Supplement 12Labeling · Standard reviewApprovedNone posted
Jan 5, 2024Supplement 7Labeling · Standard reviewApprovedNone posted
Jan 5, 2024Supplement 8Labeling · Standard reviewApprovedNone posted
Jan 5, 2024Supplement 10Labeling · Standard reviewApprovedNone posted
Mar 12, 2020Supplement 2Labeling · Standard reviewApprovedNone posted
Mar 12, 2020Supplement 5Labeling · Standard reviewApprovedNone posted
Oct 31, 2016Original applicationApprovedNone posted

Identifiers

Application
ANDA 206434

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

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