Hypercholesterolemia

• FDA label_change · 2026-07-31
  FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA supplemental approval for rosuvastatin calcium from Torrent Pharmaceuticals Limited.

• FDA label_change · 2026-01-09
  FDA Approved: NEXLETOL — Supplemental Application (Esperion Therapeutics, Inc.)

  The FDA approved a supplemental application for Nexletol (bempedoic acid) from Esperion Therapeutics, Inc., expanding the drug's labeling.

• FDA label_change · 2025-02-12
  FDA Approved: EZALLOR SPRINKLE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for EZALLOR SPRINKLE (rosuvastatin) to support the sprinkle dosage-form labeling. This action expand…

• FDA label_change · 2023-08-04
  FDA Approved: EZALLOR SPRINKLE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for EZALLOR SPRINKLE (rosuvastatin) from Sun Pharmaceutical Industries.

• FDA label_change · 2015-11-05
  FDA Approved: LESCOL XL — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for LESCOL XL (fluvastatin sodium) submitted by Sandoz Inc, resulting in labeling changes.

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• FDA label_change · 2014-05-22
  FDA Approved: COLESTID — Supplemental Application (Pharmacia & Upjohn Company LLC)

  The FDA approved a supplemental labeling application for COLESTID (colestipol hydrochloride) submitted by Pharmacia & Upjohn Company LLC to …

• FDA label_change · 2012-04-26
  FDA Approved: SIMVASTATIN — Supplemental Application (NorthStar Rx LLC)

  FDA approved a supplemental application for simvastatin submitted by NorthStar Rx LLC.

• FDA label_change · 2008-11-18
  FDA Approved: SIMVASTATIN — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved a supplemental application for simvastatin by Lupin Pharmaceuticals, likely involving labeling changes. This represents a suppl…