Hemophilia

• FDA approval · 2019-01-28
  FDA Approved: DESMOPRESSIN ACETATE — Original Application (KVK-TECH, INC.)

  The FDA approved Desmopressin Acetate from KVK-Tech under an Original Application, providing a new generic option for this drug product.

• FDA approval · 2018-11-27
  FDA Approved: AMINOCAPROIC ACID — Original Application (Vitruvias Therapeutics)

  FDA approved Vitruvias Therapeutics' original application for aminocaproic acid, a generic antifibrinolytic. The approval covers its use to …

• FDA approval · 2018-10-04
  FDA Approved: HEMLIBRA — Supplemental Application (Genentech, Inc.)

  FDA approved a supplemental application for Hemlibra (emicizumab) submitted by Genentech, Inc.

• FDA approval · 2018-05-14
  FDA Approved: TRANEXAMIC ACID — Supplemental Application (Mylan Institutional LLC)

  FDA approved a supplemental application for tranexamic acid from Mylan Institutional LLC, granting approval for the generic product.

• FDA approval · 2017-08-22
  FDA Approved: DESMOPRESSIN ACETATE — Original Application (Sagent Pharmaceuticals)

  FDA approved the Original Application for Desmopressin Acetate (DESMOPRESSIN ACETATE) by Sagent Pharmaceuticals, providing a generic version…

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• FDA approval · 2017-08-22
  FDA Approved: DESMOPRESSIN ACETATE — Original Application (Sagent Pharmaceuticals)

  FDA approved an original application for Desmopressin Acetate from Sagent Pharmaceuticals, establishing a generic version of the product.

• FDA approval · 2017-05-26
  FDA Approved: DESMOPRESSIN ACETATE — Original Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved an Original Application for Desmopressin Acetate as a generic product manufactured by Heritage Pharmaceuticals Inc. d/b/a Avet …

• FDA approval · 2015-05-28
  FDA Approved: DESMOPRESSIN ACETATE — Original Application (Glenmark Pharmaceuticals Inc.,USA)

  The FDA approved Glenmark's Desmopressin Acetate as an Original Application (ANDA201831), authorizing the generic product to be marketed for…

• FDA approval · 2015-01-23
  FDA Approved: DESMOPRESSIN ACETATE — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application for Desmopressin Acetate from Apotex Corp. under an ANDA.

• FDA approval · 2015-01-14
  FDA Approved: DESMOPRESSIN ACETATE — Supplemental Application (Bauch & Lomb Incorporated)

  FDA approved a supplemental application for desmopressin acetate from Bauch & Lomb Incorporated under an ANDA.

• FDA approval · 2014-02-28
  FDA Approved: DDAVP — Supplemental Application (Ferring Pharmaceuticals Inc.)

  The FDA approved a supplemental application for DDAVP (desmopressin acetate) filed by Ferring Pharmaceuticals Inc. The action updates the pr…

• FDA approval · 2013-01-25
  FDA Approved: DESMOPRESSIN ACETATE — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved an Abbreviated New Drug Application for Desmopressin Acetate from Sun Pharmaceutical Industries, marking a generic product appr…

• FDA approval · 2009-03-27
  FDA Approved: DESMOPRESSIN ACETATE — Supplemental Application (Meitheal Pharmaceuticals Inc.)

  FDA approved a supplemental application for Desmopressin Acetate submitted by Meitheal Pharmaceuticals Inc.

• FDA approval · 2008-09-03
  FDA Approved: DESMOPRESSIN ACETATE — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application for Desmopressin Acetate from Apotex Corp., indicating an addition or modification to the approved p…

• FDA approval · 2008-03-11
  FDA Approved: DESMOPRESSIN ACETATE — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application for Desmopressin Acetate from Apotex Corp., updating the approved generic product. The action formal…

• FDA approval · 2007-10-26
  FDA Approved: DDAVP — Supplemental Application (Ferring Pharmaceuticals Inc.)

  FDA approved a supplemental application for DDAVP (desmopressin acetate) from Ferring Pharmaceuticals Inc., updating the product's labeling.

• FDA approval · 2007-05-23
  FDA Approved: DESMOPRESSIN ACETATE — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application for Desmopressin Acetate submitted by Apotex Corp. under an ANDA.

• FDA approval · 2006-12-03
  FDA Approved: DESMOPRESSIN ACETATE — Supplemental Application (Apotex Corp.)

  FDA granted a supplemental approval for Desmopressin Acetate from Apotex Corp. under an ANDA, authorizing its generic product.