Dysmenorrhea

• FDA approval · 2022-01-05
  FDA Approved: CELECOXIB — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental application for a generic celecoxib product (Celecoxib) under ANDA 202240.

• FDA approval · 2021-04-30
  FDA Approved: SULINDAC — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for sulindac from Sun Pharmaceutical Industries, Inc., authorizing changes to its labeling and/o…

• FDA approval · 2021-04-28
  FDA Approved: NAPROXEN — Supplemental Application (Acella Pharmaceuticals, LLC)

  The FDA approved a supplemental application for Naproxen filed by Acella Pharmaceuticals, LLC, updating the product's approval status.

• FDA approval · 2021-04-28
  FDA Approved: INDOMETHACIN — Supplemental Application (XLCare Pharmaceuticals Inc.)

  FDA approved a supplemental application for Indomethacin from XLCare Pharmaceuticals Inc. This approval updates the drug's existing FDA appr…

• FDA approval · 2021-04-28
  FDA Approved: MECLOFENAMATE SODIUM — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for meclofenamate sodium from Mylan Pharmaceuticals Inc.

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• FDA approval · 2021-04-28
  FDA Approved: IBUPROFEN — Supplemental Application (Major Pharmaceuticals)

  The FDA approved Major Pharmaceuticals' ibuprofen supplemental application, finalizing regulatory changes for this product under an ANDA pro…

• FDA approval · 2021-04-26
  FDA Approved: DICLOFENAC POTASSIUM — Supplemental Application (Trifluent Pharma LLC)

  FDA approved a supplemental application for Diclofenac potassium from Trifluent Pharma LLC as a generic product.

• FDA approval · 2021-04-26
  FDA Approved: INDOMETHACIN — Supplemental Application (XLCare Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Indomethacin submitted by XLCare Pharmaceuticals Inc. under ANDA 091240.

• FDA approval · 2021-03-31
  FDA Approved: DICLOFENAC SODIUM — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for Diclofenac Sodium from Actavis Pharma, Inc. under ANDA074514. The approval covers an updated for…

• FDA approval · 2021-03-26
  FDA Approved: DICLOFENAC SODIUM — Supplemental Application (Oceanside Pharmaceuticals)

  FDA approved Oceanside Pharmaceuticals' supplemental application for diclofenac sodium (a generic NSAID).

• FDA approval · 2020-12-12
  FDA Approved: NAPROXEN SODIUM — Supplemental Application (Bionpharma Inc.)

  The FDA approved a supplemental application for Naproxen Sodium from Bionpharma Inc., resulting in changes to the product labeling. This act…

• FDA approval · 2020-12-03
  FDA Approved: CELECOXIB — Original Application (ScieGen Pharmaceuticals, Inc.)

  FDA approved the original ANDA for Celecoxib from ScieGen Pharmaceuticals, a generic version of the COX-2 inhibitor used for pain relief. It…

• FDA approval · 2020-10-28
  FDA Approved: ALEVE GELCAPS — Supplemental Application (Bayer HealthCare LLC.)

  FDA approved a supplemental application to add Aleve GelCaps (naproxen sodium) as a new gelcap dosage form for naproxen sodium, expanding th…

• FDA approval · 2020-07-28
  FDA Approved: NAPROXEN — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved a supplemental application for Naproxen from Glenmark Pharmaceuticals to update the labeling for the generic product under the …

• FDA approval · 2020-05-08
  FDA Approved: IBUPROFEN — Original Application (Aurobindo Pharma Limited)

  FDA approved Aurobindo Pharma Limited's ibuprofen generic under Original Application (ANDA213794). The product is a generic version of ibupr…

• FDA approval · 2020-03-19
  FDA Approved: NAPROXEN — Supplemental Application (Aurobindo Pharma Limited)

  FDA approves Aurobindo Pharma Limited's supplemental application for naproxen (generic) under ANDA075390. This action constitutes a suppleme…

• FDA approval · 2020-03-06
  FDA Approved: CELECOXIB — Original Application (Chartwell RX, LLC)

  FDA approved the original generic application for celecoxib (Celecoxib) by Chartwell RX, LLC.

• FDA approval · 2020-02-25
  FDA Approved: CELECOXIB — Original Application (EPIC PHARMA, LLC)

  FDA approved the Original Application (ANDA) for a generic Celecoxib product from Epic Pharma, LLC, enabling its marketing as a COX-2 inhibi…

• FDA approval · 2019-12-03
  FDA Approved: DICLOFENAC POTASSIUM — Original Application (Lifsa Drugs LLC)

  FDA approved the original application for diclofenac potassium as a generic NSAID for relief of pain and inflammation associated with variou…

• FDA approval · 2019-11-27
  FDA Approved: CELECOXIB — Original Application (NIVAGEN PHARMACEUTICALS, INC.)

  The FDA approved NIVAGEN Pharmaceuticals, Inc.'s original application for a generic celecoxib product.

• FDA approval · 2019-11-22
  FDA Approved: NAPROXEN SODIUM — Supplemental Application (CVS)

  FDA approved a supplemental application for Naproxen Sodium from CVS under ANDA 091353, resulting in updated approval for the product.

• FDA approval · 2019-11-15
  FDA Approved: NAPROXEN — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for a generic Naproxen product from Hikma Pharmaceuticals USA Inc. This action expands access to…

• FDA approval · 2019-11-14
  FDA Approved: CELECOXIB — Original Application (Modavar Pharmaceuticals LLC)

  The FDA approved Modavar Pharmaceuticals LLC's original application for a generic version of celecoxib (Celecoxib).

• FDA approval · 2019-10-26
  FDA Approved: NAPROXEN SODIUM — Supplemental Application (Bionpharma Inc.)

  FDA approved a supplemental application for Naproxen Sodium from Bionpharma Inc., resulting in an approved modification to the product’s lab…

• FDA approval · 2019-10-09
  FDA Approved: CELECOXIB — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for Celecoxib submitted by Actavis Pharma, Inc.