Uterine Fibroids

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

  FDA approved a supplemental application for VABRINTY (leuprolide acetate) submitted by URONOVA Pharmaceuticals.

• FDA approval · 2015-05-08
  FDA Approved: LEUPROLIDE ACETATE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for Leuprolide acetate submitted by Sun Pharmaceutical Industries, Inc.

• FDA approval · 2015-01-20
  FDA Approved: TRELSTAR — Supplemental Application (Verity Pharmaceuticals Inc.)

  FDA approved a supplemental application for TRELSTAR (triptorelin pamoate) from Verity Pharmaceuticals Inc. The action expands the product's…

• FDA approval · 2014-10-10
  FDA Approved: VABRINTY — Supplemental Application (URONOVA PHARMACEUTICALS, INC.)

  FDA approved a supplemental application for VABRINTY (leuprolide acetate) from URONOVA Pharmaceuticals.

• FDA approval · 2014-07-18
  FDA Approved: VABRINTY — Supplemental Application (URONOVA PHARMACEUTICALS, INC.)

  FDA approves a supplemental application for VABRINTY (leuprolide acetate) submitted by Uronova Pharmaceuticals, Inc. The approval updates th…

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• FDA approval · 2013-02-27
  FDA Approved: VABRINTY — Supplemental Application (URONOVA PHARMACEUTICALS, INC.)

  FDA approved a supplemental application for VABRINTY (leuprolide acetate) submitted by Uronova Pharmaceuticals, Inc. The approval pertains t…

• FDA approval · 2013-02-08
  FDA Approved: VABRINTY — Supplemental Application (URONOVA PHARMACEUTICALS, INC.)

  FDA approved a supplemental application for VABRINTY (leuprolide acetate) by URONOVA Pharmaceuticals.

• FDA approval · 2012-01-23
  FDA Approved: LUPRON DEPOT — Supplemental Application (AbbVie Inc.)

  FDA approved a supplemental application for Lupron Depot (leuprolide acetate) from AbbVie, resulting in an updated approval and labeling for…

• FDA approval · 2011-06-14
  FDA Approved: LUPRON DEPOT — Supplemental Application (AbbVie Inc.)

  FDA approved a supplemental application for LUPRON DEPOT (leuprolide acetate) by AbbVie, expanding its approved indications and labeling.

• FDA approval · 2011-04-26
  FDA Approved: LEUPROLIDE ACETATE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for Leuprolide Acetate from Sun Pharmaceutical Industries, resulting in changes to the product's…

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

  FDA approved a supplemental application for VABRINTY (leuprolide acetate) filed by Uronova Pharmaceuticals. This action approves the supplem…

• FDA approval · 2011-03-28
  FDA Approved: LEUPROLIDE ACETATE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application from Sandoz Inc. for Leuprolide acetate (ANDA 074728).

• FDA approval · 2010-10-05
  FDA Approved: VABRINTY — Supplemental Application (URONOVA PHARMACEUTICALS, INC.)

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

• FDA approval · 2009-03-09
  FDA Approved: LEUPROLIDE ACETATE — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved Leuprolide acetate from Sun Pharmaceutical Industries as an original application (generic) for multiple hormone-related indicat…

• FDA approval · 2007-11-08
  FDA Approved: VABRINTY — Supplemental Application (URONOVA PHARMACEUTICALS, INC.)

  FDA approved a supplemental application for VABRINTY (leuprolide acetate) from URONOVA PHARMACEUTICALS, INC., signaling an expanded/updated …

• FDA approval · 2007-02-16
  FDA Approved: TRELSTAR — Supplemental Application (Verity Pharmaceuticals Inc.)

  The FDA approved a supplemental application for TRELSTAR (triporelin pamoate) from Verity Pharmaceuticals Inc.