Osteoarthritis

• FDA approval · 2010-12-07
  FDA Approved: VOLTAREN ARTHRITIS PAIN — Supplemental Application (Haleon US Holdings LLC)

  FDA approved a supplemental application for Voltaren Arthritis Pain (diclofenac sodium) submitted by Haleon US Holdings LLC, expanding label…

• FDA approval · 2010-12-01
  FDA Approved: DICLOFENAC SODIUM — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved the original ANDA for Diclofenac Sodium (generic diclofenac) from Rising Pharma Holdings, Inc., providing a generic diclofenac …

• FDA approval · 2010-11-01
  FDA Approved: TAPENTADOL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental NDA for tapentadol hydrochloride by Hikma Pharmaceuticals USA Inc., allowing a generic version of tapentadol to …

• FDA approval · 2010-10-26
  FDA Approved: MELOXICAM — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for MELOXICAM (meloxicam) from Zydus Pharmaceuticals USA Inc., resulting in changes to the labeling.…

• FDA approval · 2010-08-12
  FDA Approved: NAPROXEN SODIUM — Supplemental Application (Bionpharma Inc.)

  The FDA approved a supplemental application for Naproxen Sodium submitted by Bionpharma Inc.

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• FDA approval · 2010-07-29
  FDA Approved: ZYBIC — Supplemental Application (Redmont Pharmaceuticals, LLC)

  FDA approved a supplemental application for ZYBIC (meloxicam) from Redmont Pharmaceuticals, LLC. The action pertains to a supplemental appro…

• FDA approval · 2010-07-06
  FDA Approved: DICLOFENAC SODIUM — Supplemental Application (Edenbridge Pharmaceuticals LLC.)

  FDA approved a supplemental application for diclofenac sodium from Edenbridge Pharmaceuticals LLC under the ANDA program. This action consti…

• FDA approval · 2010-04-26
  FDA Approved: ZYBIC — Supplemental Application (Redmont Pharmaceuticals, LLC)

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

• 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 · 2010-03-17
  FDA Approved: INDOMETHACIN — Original Application (Fresenius Kabi USA, LLC)

  The FDA approved an original NDA for indomethacin from Fresenius Kabi USA, LLC. The approval covers indications for inflammatory and musculo…

• FDA approval · 2009-10-01
  FDA Approved: SULINDAC — Supplemental Application (PuraCap Laboratories LLC dba Blu Pharmaceuticals)

  FDA approved a supplemental application for the generic NSAID sulindac from PuraCap Laboratories LLC dba Blu Pharmaceuticals (ANDA072711).

• FDA approval · 2009-09-24
  FDA Approved: MELOXICAM — Supplemental Application (Carlsbad Technology, Inc.)

  The FDA approved a supplemental application for Meloxicam from Carlsbad Technology, Inc., indicating the supplemental action for the generic…

• FDA approval · 2009-09-23
  FDA Approved: VOLTAREN ARTHRITIS PAIN — Supplemental Application (Haleon US Holdings LLC)

  FDA approves a supplemental application for Voltaren Arthritis Pain (diclofenac sodium) by Haleon US Holdings LLC, updating its labeling.

• FDA approval · 2009-09-04
  FDA Approved: VOLTAREN ARTHRITIS PAIN — Supplemental Application (Haleon US Holdings LLC)

  The FDA approved a supplemental NDA for Voltaren Arthritis Pain (diclofenac sodium) submitted by Haleon US Holdings LLC, expanding its label…

• FDA approval · 2009-03-24
  FDA Approved: IBUPROFEN — Original Application (DOLGENCORP INC)

  The FDA approved DolGenCorp Inc's original application for ibuprofen, establishing a generic ibuprofen product (capsules, including liquid-f…

• FDA approval · 2009-03-06
  FDA Approved: INDOMETHACIN — Original Application (KVK-Tech, Inc.)

  FDA approved an original application for Indomethacin by KVK-Tech, Inc., establishing a generic version of indomethacin. The approval signif…

• FDA approval · 2009-01-14
  FDA Approved: ETODOLAC — Supplemental Application (Taro Pharmaceuticals U.S.A., Inc.)

  The FDA approved a supplemental application for etodolac by Taro Pharmaceuticals U.S.A., Inc. under the ANDA program.

• FDA approval · 2009-01-14
  FDA Approved: ETODOLAC — Supplemental Application (Taro Pharmaceuticals U.S.A., Inc.)

  FDA approved a supplemental application for etodolac filed by Taro Pharmaceuticals U.S.A., Inc., authorizing changes to labeling and/or manu…

• 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 · 2008-09-24
  FDA Approved: NABUMETONE — Original Application (ScieGen Pharmaceuticals Inc)

  FDA approves ScieGen Pharmaceuticals Inc's Nabumetone as a generic product under an Original Application (ANDA), marking its regulatory appr…

• FDA approval · 2008-07-31
  FDA Approved: TOLMETIN SODIUM — Supplemental Application (Atland Pharmaceuticals, LLC)

  FDA approved a supplemental application for Tolmetin Sodium from Atland Pharmaceuticals, LLC.

• 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 · 2008-03-07
  FDA Approved: NABUMETONE — Original Application (Exelan Pharmaceuticals Inc.)

  FDA approved Nabumetone as a generic product under an original ANDA submitted by Exelan Pharmaceuticals Inc.

• FDA approval · 2008-02-20
  FDA Approved: SALONPAS PAIN RELIEF — Original Application (Hisamitsu Pharmaceutical Co., Inc.)

  The FDA approved the original application for SALONPAS PAIN RELIEF by Hisamitsu, a topical analgesic patch containing menthol and methyl sal…