Hyperuricemia

• FDA approval · 2019-03-19
  FDA Approved: ALLOPURINOL — Supplemental Application (Chartwell RX, LLC)

  The FDA approved a supplemental application for allopurinol (generic) submitted by Chartwell RX, LLC.

• FDA approval · 2019-03-12
  FDA Approved: ALLOPURINOL — Original Application (Unichem Pharmaceuticals (USA), Inc.)

  The FDA approved Unichem Pharmaceuticals (USA), Inc.'s original application for Allopurinol, a generic drug used to treat gout and hyperuric…

• FDA approval · 2019-02-21
  FDA Approved: ULORIC — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved a supplemental application for ULORIC (febuxostat) from Takeda Pharmaceuticals America, Inc., reflecting an additional regulato…

• FDA approval · 2018-12-03
  FDA Approved: ALLOPURINOL — Supplemental Application (Rising Pharma Holdings, Inc.)

  The FDA approved a supplemental application for Allopurinol filed by Rising Pharma Holdings, Inc.

• FDA approval · 2017-08-15
  FDA Approved: ULORIC — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  The FDA approved a supplemental application for ULORIC (febuxostat) submitted by Takeda Pharmaceuticals America, Inc. The submission status …

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• FDA approval · 2016-09-09
  FDA Approved: ALLOPURINOL SODIUM — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Allopurinol Sodium (generic) from Hikma Pharmaceuticals USA Inc. under an ANDA.

• FDA approval · 2016-07-28
  FDA Approved: ALLOPURINOL — Original Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved an original (generic) application for allopurinol from Heritage Pharmaceuticals Inc. (d/b/a Avet Pharmaceuticals Inc.).

• FDA approval · 2015-11-13
  FDA Approved: ALLOPURINOL — Supplemental Application (Actavis Pharma, Inc.)

  The FDA approved a supplemental application for Allopurinol from Actavis Pharma, Inc. (NDA018877).

• FDA approval · 2015-05-13
  FDA Approved: ALOPRIM — Supplemental Application (Mylan Institutional LLC)

  The FDA approved a supplemental application for ALOPRIM (allopurinol) submitted by Mylan Institutional LLC, resulting in updated labeling.

• FDA approval · 2013-12-12
  FDA Approved: ULORIC — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved a supplemental application for ULORIC (febuxostat) by Takeda Pharmaceuticals America, Inc.

• FDA approval · 2013-05-06
  FDA Approved: ALLOPURINOL — Original Application (Accord Healthcare Inc.)

  FDA approved Accord Healthcare's original application for the generic drug allopurinol. Allopurinol is used to treat gout and to lower uric …

• FDA approval · 2012-11-01
  FDA Approved: ULORIC — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  The FDA approved a supplemental application for ULORIC (febuxostat) from Takeda Pharmaceuticals America, Inc.

• FDA approval · 2011-01-28
  FDA Approved: ULORIC — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  The FDA approved a supplemental application for ULORIC (febuxostat) submitted by Takeda Pharmaceuticals America, Inc. This notice indicates …

• FDA approval · 2009-02-13
  FDA Approved: ULORIC — Original Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved ULORIC (febuxostat) as the original application to treat hyperuricemia associated with gout by lowering serum uric acid levels.…

• FDA approval · 2009-01-23
  FDA Approved: ALLOPURINOL — Supplemental Application (Actavis Pharma, Inc.)

  The FDA approved a supplemental application for allopurinol from Actavis Pharma, updating the existing NDA.

• FDA approval · 2009-01-23
  FDA Approved: ALLOPURINOL — Supplemental Application (Actavis Pharma, Inc.)

  FDA approves a supplemental application for Allopurinol submitted by Actavis Pharma, Inc.

• FDA approval · 2008-05-13
  FDA Approved: PROBENECID AND COLCHICINE — Original Application (Ingenus Pharmaceuticals, LLC)

  FDA approved Ingenus Pharmaceuticals' generic Probenecid and Colchicine as an original ANDA.

• FDA approval · 2007-08-22
  FDA Approved: ALLOPURINOL — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for allopurinol (ALLOPURINOL) from Sun Pharmaceutical Industries, Inc. The action represents a regul…

• FDA approval · 2006-05-15
  FDA Approved: PROBENECID — Supplemental Application (Lannett Company, Inc.)

  FDA has approved a supplemental application for Probenecid from Lannett Company, Inc., confirming the supplemental regulatory action on this…