Osteoarthritis

• FDA approval · 2013-11-30
  FDA Approved: TOPCARE 8 HR ARTHRITIS PAIN RELIEF — Supplemental Application (Topco Associates LLC)

  FDA approved a supplemental application for TOPCARE 8 HR Arthritis Pain Relief containing acetaminophen, issued to Topco Associates LLC.

• FDA approval · 2013-10-28
  FDA Approved: DICLOFENAC SODIUM — Original Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved Amneal's Original Application for Diclofenac Sodium Tablets, a generic NSAID indicated for relief of pain and inflammation in s…

• FDA approval · 2013-06-13
  FDA Approved: MELOXICAM — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved a supplemental application for meloxicam from Unichem Pharmaceuticals (USA), Inc., enabling a generic version of the NSAID for …

• FDA approval · 2013-06-12
  FDA Approved: MELOXICAM — Supplemental Application (Carlsbad Technology, Inc.)

  FDA approved a supplemental application for Meloxicam (Carlsbad Technology, Inc.), a generic NSAID, under ANDA077918. The approval concerns …

• FDA approval · 2013-04-18
  FDA Approved: ALEVE GELCAPS — Supplemental Application (Bayer HealthCare LLC.)

  FDA approves a supplemental application for Aleve GelCaps to expand labeling for naproxen sodium, broadening indications for pain relief.

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2013-03-07
  FDA Approved: DICLOFENAC SODIUM AND MISOPROSTOL — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental NDA for diclofenac sodium and misoprostol from Mylan Pharmaceuticals.

• FDA approval · 2013-02-07
  FDA Approved: ALEVE GELCAPS — Supplemental Application (Bayer HealthCare LLC.)

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

• FDA approval · 2013-02-07
  FDA Approved: ETODOLAC — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application for Etodolac from Apotex Corp. under an ANDA.

• FDA approval · 2012-10-01
  FDA Approved: OXAPROZIN — Supplemental Application (Chartwell RX, LLC.)

  FDA approved a supplemental application for Oxaprozin filed by Chartwell RX, LLC., updating an existing approved generic oxaprozin product.

• FDA approval · 2012-09-28
  FDA Approved: INDOMETHACIN — Original Application (Camber Pharmaceuticals, Inc.)

  The FDA approved Camber Pharmaceuticals' indomethacin as an original ANDA (generic) application, making Indomethacin available as a generic …

• FDA approval · 2012-07-09
  FDA Approved: DICLOFENAC SODIUM AND MISOPROSTOL — Original Application (BluePoint Laboratories)

  FDA approved a diclofenac sodium and misoprostol product under an Original Application for BluePoint Laboratories, signaling a generic clear…

• FDA approval · 2012-06-13
  FDA Approved: NAPROXEN SODIUM — Supplemental Application (Bionpharma Inc.)

  FDA approved a supplemental application for Naproxen Sodium from Bionpharma Inc., updating the product's regulatory approval.

• FDA approval · 2012-03-15
  FDA Approved: ALEVE GELCAPS — Supplemental Application (Bayer HealthCare LLC.)

  FDA approved a supplemental application to add Aleve GelCaps containing naproxen sodium, expanding the approval to include a new dosage form…

• FDA approval · 2012-03-05
  FDA Approved: ZYBIC — Supplemental Application (Redmont Pharmaceuticals, LLC)

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

• FDA approval · 2011-12-23
  FDA Approved: TYLENOL 8 HR ARTHRITIS PAIN — Supplemental Application (Kenvue Brands LLC)

  FDA approves a supplemental application for Tylenol 8 Hour Arthritis Pain (acetaminophen) from Kenvue Brands LLC, expanding or updating labe…

• FDA approval · 2011-11-08
  FDA Approved: NAPROXEN — Original Application (Aurobindo Pharma Limited)

  The FDA approved Aurobindo Pharma Limited's original application for a generic naproxen product. Naproxen is a nonsteroidal anti-inflammator…

• FDA approval · 2011-10-31
  FDA Approved: MELOXICAM — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for Meloxicam from Aurobindo Pharma Limited. This approval updates the approved product under th…

• FDA approval · 2011-09-23
  FDA Approved: TECHNETIUM TC 99M MEDRONATE — Supplemental Application (Jubilant DraxImage Inc., dba Jubilant Radiopharma)

  FDA approves a supplemental application for Technetium Tc-99m medronate (Medronate) from Jubilant Radiopharma, updating labeling to reflect …

• FDA approval · 2011-09-19
  FDA Approved: NAPROXEN — Original Application (Cipla USA Inc.)

  FDA approves Cipla USA Inc.'s Naproxen under Original Application, making a generic naproxen product available. It is used to relieve pain a…

• FDA approval · 2011-08-24
  FDA Approved: NAPROXEN — Original Application (Exelan Pharmaceuticals, Inc.)

  The FDA approved Exelan Pharmaceuticals' original ANDA for Naproxen (generic naproxen). This confirms a generic naproxen product for arthrit…

• FDA approval · 2011-06-13
  FDA Approved: NABUMETONE — Original Application (Actavis Pharma, Inc.)

  FDA approves the original application for Nabumetone as a generic (ANDA) drug manufactured by Actavis Pharma, Inc.

• FDA approval · 2011-04-12
  FDA Approved: CYMBALTA — Supplemental Application (Eli Lilly and Company)

  The FDA approved a supplemental application for Cymbalta (duloxetine hydrochloride) submitted by Eli Lilly and Company.

• FDA approval · 2011-04-12
  FDA Approved: INDOMETHACIN — Original Application (XLCare Pharmaceuticals Inc.)

  FDA approved the Indomethacin Original Application for XLCare Pharmaceuticals Inc., enabling a generic indomethacin product to reach the mar…

• FDA approval · 2011-01-12
  FDA Approved: NABUMETONE — Original Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals' generic Nabumetone (Nabumetone) original application, enabling its use for relief of pain and inflam…

• FDA approval · 2010-12-10
  FDA Approved: IBUPROFEN — Original Application (Dolgencorp, Inc.)

  FDA approved Dolgencorp, Inc.'s ibuprofen 200 mg tablets as an original generic application (ANDA). The approval supports OTC use for relief…