Dysmenorrhea

• FDA approval · 2010-03-19
  FDA Approved: DICLOFENAC SODIUM — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for diclofenac sodium from Aurobindo Pharma Limited. This action authorizes changes to the approved …

• 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 …

• 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 · 2008-06-20
  FDA Approved: JUNIOR STRENGTH ADVIL — Supplemental Application (Haleon US Holdings LLC)

  FDA approves a supplemental application for JUNIOR STRENGTH ADVIL (ibuprofen) from Haleon US Holdings LLC.

• FDA approval · 2008-01-14
  FDA Approved: CELEBREX — Supplemental Application (Viatris Specialty LLC)

  FDA approved a supplemental application for Celebrex (celecoxib) submitted by Viatris Specialty LLC to update the product labeling under NDA…

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• 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 · 2007-07-26
  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…