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Rosuvastatin Calcium

ANDA 79161, held by Strides Pharma Intl. Rosuvastatin Calcium.

  • First approved: Jul 19, 2016
  • 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
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 7 submissions, including labeling and manufacturing supplements
DateSubmissionStatusDocuments
Oct 24, 2024Supplement 8Labeling · Standard reviewApprovedNone posted
Jun 26, 2024Supplement 4Labeling · Standard reviewApprovedNone posted
Jun 26, 2024Supplement 6Labeling · Standard reviewApprovedNone posted
Jun 26, 2024Supplement 7Labeling · Standard reviewApprovedNone posted
Apr 7, 2020Supplement 1Labeling · Standard reviewApprovedNone posted
Apr 7, 2020Supplement 3Labeling · Standard reviewApprovedNone posted
Jul 19, 2016Original applicationApprovedLetterLetter

Identifiers

Application
ANDA 79161

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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