Osteoarthritis

• FDA approval · 2016-02-08
  FDA Approved: IBUPROFEN — Supplemental Application (TIME CAP LABORATORIES,INC)

  FDA approved a supplemental application for ibuprofen tablets from Time Cap Laboratories, Inc.

• FDA approval · 2015-12-23
  FDA Approved: CELECOXIB — Original Application (Torrent Pharmaceuticals Limited)

  FDA approved the original application for generic celecoxib by Torrent Pharmaceuticals Limited. This marks approval of a generic version of …

• FDA approval · 2015-12-22
  FDA Approved: DULOXETINE DELAYED-RELEASE — Supplemental Application (Breckenridge Pharmaceutical, Inc.)

  The FDA approved Breckenridge Pharmaceutical's supplemental application for a duloxetine hydrochloride delayed-release product, granting app…

• FDA approval · 2015-12-02
  FDA Approved: DICLOFENAC SODIUM — Original Application (Actavis Pharma, Inc.)

  The FDA approved Actavis Pharma's original application for diclofenac sodium, granting clearance for its generic NSAID product. It is indica…

• FDA approval · 2015-10-28
  FDA Approved: DULOXETINE — Original Application (ANI Pharmaceuticals, Inc.)

  The FDA approved ANI Pharmaceuticals' original ANDA for duloxetine, allowing a generic version to be marketed. The approval covers duloxetin…

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• FDA approval · 2015-09-23
  FDA Approved: CELECOXIB — Original Application (Cipla USA Inc.)

  FDA approves Cipla USA Inc.'s Celecoxib under an Original Application for generic Celecoxib. The approval covers multiple indications common…

• FDA approval · 2015-08-24
  FDA Approved: NAPROXEN — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Naproxen by Hikma Pharmaceuticals USA Inc., indicating changes to the product's approval.

• FDA approval · 2015-08-21
  FDA Approved: CELECOXIB — Original Application (Alembic Pharmaceuticals Inc.)

  FDA approved Alembic Pharmaceuticals' original application for a generic Celecoxib product. This marks the entry of a generic celecoxib into…

• FDA approval · 2015-08-20
  FDA Approved: DICLOFENAC SODIUM 1.5% — Original Application (SOLA Pharmaceuticals)

  FDA approved the Original Application for DICLOFENAC SODIUM 1.5% topical from SOLA Pharmaceuticals, a generic diclofenac topical product for…

• FDA approval · 2015-07-01
  FDA Approved: MELOXICAM — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals' supplemental application for Meloxicam, a generic NSAID, confirming continued availability of the pr…

• FDA approval · 2015-06-09
  FDA Approved: CELECOXIB — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approves Lupin Pharmaceuticals' Original Application for celecoxib, enabling a generic version of Celecoxib to enter the market.

• FDA approval · 2015-05-28
  FDA Approved: SULINDAC — Supplemental Application (PuraCap Laboratories LLC dba Blu Pharmaceuticals)

  The FDA approved a supplemental application for sulindac from PuraCap Laboratories dba Blu Pharmaceuticals, updating the product’s labeling …

• FDA approval · 2015-05-11
  FDA Approved: VOLTAREN ARTHRITIS PAIN — Supplemental Application (Haleon US Holdings LLC)

  The FDA approved a supplemental application for Voltaren Arthritis Pain (diclofenac sodium) submitted by Haleon US Holdings LLC.

• FDA approval · 2014-12-23
  FDA Approved: TYLENOL 8 HR ARTHRITIS PAIN — Supplemental Application (Kenvue Brands LLC)

  FDA approved a supplemental application for Tylenol 8 Hour Arthritis Pain (acetaminophen) from Kenvue Brands LLC.

• FDA approval · 2014-12-12
  FDA Approved: TYLENOL 8 HR ARTHRITIS PAIN — Supplemental Application (Kenvue Brands LLC)

  FDA approved a supplemental application for Tylenol 8 Hour Arthritis Pain (acetaminophen) from Kenvue Brands LLC.

• FDA approval · 2014-11-28
  FDA Approved: DICLOFENAC SODIUM — Supplemental Application (Aurobindo Pharma Limited)

  FDA supplemental approval for a diclofenac sodium product manufactured by Aurobindo Pharma Limited.

• FDA approval · 2014-11-02
  FDA Approved: NAPROXEN — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved a supplemental application for Naproxen by Amneal Pharmaceuticals of New York LLC (generic Naproxen).

• FDA approval · 2014-10-29
  FDA Approved: CELECOXIB — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' generic version of celecoxib (Celecoxib) under an original ANDA.

• FDA approval · 2014-10-16
  FDA Approved: INDOCIN — Supplemental Application (Zyla Life Sciences US LLC)

  FDA approved a supplemental application for Indocin (indomethacin) submitted by Zyla Life Sciences US LLC.

• FDA approval · 2014-09-29
  FDA Approved: VOLTAREN ARTHRITIS PAIN — Supplemental Application (Haleon US Holdings LLC)

  The FDA approved a supplemental application to Voltaren Arthritis Pain (diclofenac sodium) to expand its labeling with a new indication for …

• FDA approval · 2014-09-03
  FDA Approved: DICLOFENAC SODIUM AND MISOPROSTOL — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for Diclofenac sodium and misoprostol from Mylan Pharmaceuticals, typically reflecting labeling upda…

• FDA approval · 2014-06-09
  FDA Approved: DULOXETINE HYDROCHLORIDE — Original Application (Alembic Pharmaceuticals Limited)

  FDA approved Alembic Pharmaceuticals Limited's original ANDA for duloxetine hydrochloride, establishing a generic version of duloxetine.

• FDA approval · 2014-01-23
  FDA Approved: ETODOLAC — Original Application (Zydus Pharmaceuticals USA Inc.)

  FDA approves the original ANDA for etodolac (generic) manufactured by Zydus Pharmaceuticals USA Inc.

• FDA approval · 2013-12-11
  FDA Approved: DULOXETINE — Original Application (Aurobindo Pharma Limited)

  FDA approved the original application for a generic duloxetine hydrochloride product from Aurobindo Pharma Limited.

• FDA approval · 2013-12-11
  FDA Approved: DULOXETINE — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approves Sun Pharmaceutical Industries' original application for a generic duloxetine product (DULOXETINE). This approval allows the mar…