Central Precocious Puberty

• FDA label_change · 2025-09-23
  FDA Approved: LEUPROLIDE ACETATE — Supplemental Application (NorthStar RxLLC)

  FDA approved a supplemental application for Leuprolide acetate filed by NorthStar RxLLC, indicating an update to the product labeling.

• FDA label_change · 2025-09-23
  FDA Approved: LEUPROLIDE ACETATE — Supplemental Application (Meitheal Pharmaceuticals Inc)

  FDA approved a supplemental application for Leuprolide acetate submitted by Meitheal Pharmaceuticals Inc.

• FDA label_change · 2024-01-23
  FDA Approved: VABRINTY — Supplemental Application (URONOVA PHARMACEUTICALS, INC.)

  FDA approved a supplemental application for VABRINTY (leuprolide acetate) from Uronova Pharmaceuticals to modify the drug's labeling.

• FDA label_change · 2017-05-19
  FDA Approved: LEUPROLIDE ACETATE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for Leuprolide acetate from Sun Pharmaceutical Industries, updating the labeling for this generi…

• FDA label_change · 2016-02-29
  FDA Approved: VABRINTY — Supplemental Application (URONOVA PHARMACEUTICALS, INC.)

  FDA approved a supplemental application for VABRINTY (leuprolide acetate) from URONOVA Pharmaceuticals. The supplemental action updates the …

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• FDA label_change · 2014-05-30
  FDA Approved: VABRINTY — Supplemental Application (URONOVA PHARMACEUTICALS, INC.)

  FDA approved a supplemental application for VABRINTY (leuprolide acetate) from URONOVA Pharmaceuticals. This notice relates to regulatory ac…

• FDA label_change · 2013-01-25
  FDA Approved: VABRINTY — Supplemental Application (URONOVA PHARMACEUTICALS, INC.)

  FDA approved a supplemental application for VABRINTY (leuprolide acetate) from Uronova Pharmaceuticals, resulting in labeling changes for th…

• FDA label_change · 2011-04-08
  FDA Approved: VABRINTY — Supplemental Application (URONOVA PHARMACEUTICALS, INC.)

  The FDA approved a supplemental application for VABRINTY (leuprolide acetate) from URONOVA PHARMACEUTICALS, INC.

• FDA label_change · 2011-01-14
  FDA Approved: ZOLADEX — Supplemental Application (TerSera Therapeutics LLC)

  FDA approved a supplemental application for ZOLADEX (goserelin) from TerSera Therapeutics LLC. The approval includes changes to the product …

• FDA label_change · 2007-11-21
  FDA Approved: SUPPRELIN LA — Supplemental Application (Endo USA, Inc.)

  FDA approved a supplemental application for SUPPRELIN LA (histrelin acetate) submitted by Endo USA, Inc., resulting in changes to the produc…