Dysmenorrhea

• FDA approval · 2019-08-07
  FDA Approved: CELECOXIB — Original Application (AiPing Pharmaceutical, Inc.)

  The FDA approved AiPing Pharmaceutical, Inc.'s original ANDA for celecoxib, establishing a generic version of the COX-2 inhibitor. The appro…

• FDA approval · 2019-07-25
  FDA Approved: CELECOXIB — Supplemental Application (Aurobindo Pharma Limited)

  FDA approves Aurobindo Pharma Limited's supplemental application for Celecoxib (generic Celecoxib), confirming the generic's approval. Celec…

• FDA approval · 2019-07-22
  FDA Approved: IBUPROFEN — Supplemental Application (Chartwell RX, LLC)

  The FDA approved a supplemental application for ibuprofen from Chartwell RX, LLC under ANDA 202413, authorizing the specified changes to thi…

• FDA approval · 2019-07-22
  FDA Approved: IBUPROFEN — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved a supplemental application for ibuprofen by Amneal Pharmaceuticals of New York LLC.

• FDA approval · 2019-05-06
  FDA Approved: DICLOFENAC SODIUM — Original Application (Harris Teeter)

  FDA approved Harris Teeter's diclofenac sodium as a generic under an original ANDA.

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• FDA approval · 2018-11-29
  FDA Approved: NAPROXEN SODIUM — Supplemental Application (Bionpharma Inc.)

  FDA approved a supplemental application for Naproxen Sodium from Bionpharma Inc., confirming regulatory clearance for an updated product-rel…

• FDA approval · 2018-07-25
  FDA Approved: ALEVE GELCAPS — Supplemental Application (Bayer HealthCare LLC.)

  The FDA approved Bayer's supplemental application to add ALEVE GELCAPS (naproxen sodium) as an additional formulation of naproxen products.

• FDA approval · 2018-04-30
  FDA Approved: CELECOXIB — Original Application (Micro Labs Limited)

  FDA approved the original generic application for celecoxib from Micro Labs Limited, providing a generic celecoxib option aligned with the r…

• FDA approval · 2018-03-27
  FDA Approved: ALEVE GELCAPS — Supplemental Application (Bayer HealthCare LLC.)

  FDA approved a supplemental NDA for ALEVE GELCAPS (naproxen sodium) by Bayer HealthCare LLC. The approval adds a gel-cap dosage form for thi…

• FDA approval · 2018-01-23
  FDA Approved: CELECOXIB — Original Application (Westminster Pharmaceuticals, LLC)

  FDA approved Westminster Pharmaceuticals' generic celecoxib as an Original Application (ANDA210071), enabling market entry for this COX-2 in…

• FDA approval · 2017-12-21
  FDA Approved: DOLEX FLEX — Original Application (Pharmadel LLC)

  FDA approved DOLEX FLEX (ibuprofen) through Pharmadel LLC's original ANDA.

• FDA approval · 2017-08-22
  FDA Approved: ALEVE GELCAPS — Supplemental Application (Bayer HealthCare LLC.)

  FDA approved a supplemental application for ALEVE GELCAPS (naproxen sodium) by Bayer HealthCare LLC., expanding the product through a supple…

• FDA approval · 2017-06-22
  FDA Approved: INDOMETHACIN — Original Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved Glenmark's Indomethacin generic under an Original Application; this entry records the approval status and product details.

• FDA approval · 2017-03-10
  FDA Approved: NAPROXEN — Supplemental Application (Zameer Pharmaceuticals LLC)

  FDA approved a supplemental application for Naproxen by Zameer Pharmaceuticals LLC.

• FDA approval · 2017-01-23
  FDA Approved: NAPROXEN — Original Application (Amerisource Bergen)

  FDA approves AmerisourceBergen's original application for naproxen sodium tablets, a generic naproxen product.

• FDA approval · 2016-09-16
  FDA Approved: CELECOXIB — Supplemental Application (Apotex Corp.)

  The FDA approved Apotex Corp.'s supplemental application for celecoxib (generic) under ANDA204197.

• FDA approval · 2016-09-14
  FDA Approved: CELECOXIB — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for CELECOXIB from Aurobindo Pharma Limited (ANDA206827). This notice confirms the supplemental appr…

• FDA approval · 2016-09-02
  FDA Approved: DICLOFENAC SODIUM — Original Application (SOLA Pharmaceuticals, LLC)

  FDA approved SOLA Pharmaceuticals' diclofenac sodium tablet as an original generic, indicated for relief of pain and inflammation in conditi…

• FDA approval · 2016-05-09
  FDA Approved: DICLOFENAC SODIUM — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for diclofenac sodium from Aurobindo Pharma Limited.

• FDA approval · 2016-05-09
  FDA Approved: INDOMETHACIN — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' supplemental application for Indomethacin, resulting in updated labeling for the product.

• FDA approval · 2016-05-09
  FDA Approved: NAPROXEN — Supplemental Application (Zameer Pharmaceuticals LLC)

  FDA approved a supplemental application for Naproxen submitted by Zameer Pharmaceuticals LLC.

• FDA approval · 2016-05-09
  FDA Approved: SULINDAC — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for Sulindac from Sun Pharmaceutical Industries, Inc.

• FDA approval · 2016-03-16
  FDA Approved: CELECOXIB — Original Application (McKesson Corporation dba SKY Packaging)

  FDA approved the original Abbreviated New Drug Application for a generic celecoxib product manufactured by McKesson Corporation dba SKY Pack…

• FDA approval · 2016-03-15
  FDA Approved: ADVIL PM- DIPHENHYDRAMINE CITRATE AND IBUPROFEN TABLET, COATED — Supplemental Application (Lil Drug Store Products, Inc)

  FDA approved a supplemental application for Advil PM tablets (ibuprofen and diphenhydramine citrate), expanding labeling to include this com…

• FDA approval · 2016-02-25
  FDA Approved: ALEVE GELCAPS — Supplemental Application (Bayer HealthCare LLC.)

  The FDA approved a supplemental application to bring ALEVE GELCAPS (naproxen sodium) to market as a new dosage form from Bayer HealthCare LL…