Osteoarthritis

• 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.

• FDA approval · 2019-05-03
  FDA Approved: DAYPRO — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  The FDA approved a supplemental application for Daypro (oxaprozin) from Pfizer Laboratories Div Pfizer Inc, advancing regulatory action rela…

• FDA approval · 2018-11-30
  FDA Approved: ETODOLAC — Original Application (Chartwell RX, LLC)

  The FDA approved Chartwell RX, LLC's etodolac as a generic (ANDA 209888) for relief of signs and symptoms of osteoarthritis and rheumatoid a…

• 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.

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• FDA approval · 2018-06-07
  FDA Approved: ETODOLAC — Original Application (Amneal Pharmaceuticals NY LLC)

  The FDA approved the original ANDA for etodolac from Amneal Pharmaceuticals NY LLC, enabling the marketing of a generic etodolac product.

• 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 · 2017-12-29
  FDA Approved: PIROXICAM — Original Application (Micro Labs Limited)

  FDA approved Micro Labs Limited's Original Application (ANDA) for Piroxicam.

• 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 · 2017-06-16
  FDA Approved: DIFLUNISAL — Original Application (Zydus Pharmaceuticals (USA) Inc.)

  FDA approved a generic diflunisal product (DIFLUNISAL) under ANDA 203547 for Zydus Pharmaceuticals USA Inc. It is indicated for relief of mi…

• FDA approval · 2017-05-18
  FDA Approved: DULOXETINE — Original Application (Solco Healthcare US, LLC)

  FDA approved Solco Healthcare US, LLC's original application for duloxetine, enabling the marketing of a generic duloxetine product.

• FDA approval · 2017-05-04
  FDA Approved: OXAPROZIN — Original Application (Amneal Pharmaceuticals NY LLC)

  FDA approves Oxaprozin generic from Amneal Pharmaceuticals NY LLC for the treatment of rheumatoid arthritis and osteoarthritis.

• FDA approval · 2017-04-13
  FDA Approved: PIROXICAM — Original Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved Unichem Pharmaceuticals (USA), Inc.'s Original Application for piroxicam, authorizing a generic version of the NSAID piroxicam.

• FDA approval · 2017-04-06
  FDA Approved: DULOXETINE — Supplemental Application (Zydus Lifesciences Limited)

  The FDA approved a supplemental application for duloxetine submitted by Zydus Lifesciences Limited, advancing the regulatory status of the g…

• 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 · 2016-11-25
  FDA Approved: DICLOFENAC SODIUM AND MISOPROSTOL — Original Application (Amneal Pharmaceuticals LLC)

  The FDA approved Amneal Pharmaceuticals LLC's diclofenac sodium and misoprostol as an original ANDA, enabling a generic version of the diclo…

• 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 · 2016-09-01
  FDA Approved: ZYBIC — Supplemental Application (Redmont Pharmaceuticals, LLC)

  The FDA approved a supplemental application for ZYBIC (meloxicam) filed by Redmont Pharmaceuticals, LLC.