Gout

• FDA approval · 2009-03-06
  FDA Approved: INDOMETHACIN — Original Application (KVK-Tech, Inc.)

  FDA approved an original application for Indomethacin by KVK-Tech, Inc., establishing a generic version of indomethacin. The approval signif…

• 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 · 2008-10-29
  FDA Approved: NAPROXEN — Supplemental Application (Granules India Ltd)

  FDA approved a supplemental application from Granules India Ltd for Naproxen (Naproxen sodium) granules. This adds a granulated dosage form …

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• FDA approval · 2008-07-25
  FDA Approved: NAPROXEN — Supplemental Application (Zameer Pharmaceuticals LLC)

  The FDA has approved a supplemental application for naproxen filed by Zameer Pharmaceuticals LLC.

• 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 · 2007-11-07
  FDA Approved: NAPROXEN — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Naproxen (generic Naproxen) from Hikma Pharmaceuticals USA Inc., resulting in approval of a gene…

• FDA approval · 2007-09-25
  FDA Approved: NAPROXEN — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Naproxen from Hikma Pharmaceuticals USA Inc., indicating an approved change or addition to the N…

• 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 · 2007-07-26
  FDA Approved: NAPROXEN SODIUM — Original Application (Dr. Reddy's Laboratories Inc.)

  FDA approves Dr. Reddy's Laboratories' naproxen sodium as a generic version via an Original Abbreviated New Drug Application (ANDA). This co…

• FDA approval · 2007-07-15
  FDA Approved: NAPROXEN — Supplemental Application (Granules India Ltd)

  The FDA approved Granules India Ltd's supplemental application for Naproxen (naproxen sodium). This action approves a generic naproxen sodiu…

• FDA approval · 2007-03-28
  FDA Approved: NAPROXEN — Original Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved Glenmark's naproxen generic under an original ANDA, enabling market access for generic naproxen products.

• FDA approval · 2006-12-19
  FDA Approved: DG HEALTH NAPROXEN SODIUM — Supplemental Application (Dolgencorp Inc)

  FDA approved a supplemental application for DG Health Naproxen Sodium (naproxen sodium) by Dolgencorp Inc. The action approves the generic p…

• 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…