Postoperative Pain

• FDA approval · 2016-05-09
  FDA Approved: KETOROLAC TROMETHAMINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for ketorolac tromethamine from Teva Pharmaceuticals USA, Inc., indicating an approved modification …

• FDA approval · 2016-05-09
  FDA Approved: KETOROLAC TROMETHAMINE — Supplemental Application (Onesource Specialty Pharma Limited)

  The FDA approved a supplemental application for Ketorolac tromethamine filed by Onesource Specialty Pharma Limited.

• FDA approval · 2016-04-05
  FDA Approved: EXPAREL — Supplemental Application (Pacira Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for EXPAREL (bupivacaine) by Pacira Pharmaceuticals, expanding its labeling to include an additi…

• FDA approval · 2015-10-07
  FDA Approved: KETOROLAC TROMETHAMINE — Original Application (Fresenius Kabi USA, LLC)

  FDA approves a ketorolac tromethamine product from Fresenius Kabi USA, LLC under an original application for short-term management of acute …

• FDA approval · 2015-09-11
  FDA Approved: EXPAREL — Supplemental Application (Pacira Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for EXPAREL (bupivacaine) from Pacira Pharmaceuticals.

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• FDA approval · 2015-05-27
  FDA Approved: EXPAREL — Supplemental Application (Pacira Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for EXPAREL (bupivacaine liposomal injectable suspension) from Pacira Pharmaceuticals, Inc. The …

• FDA approval · 2015-03-09
  FDA Approved: CALDOLOR — Supplemental Application (Cumberland Pharmaceuticals Inc.)

  The FDA approved a supplemental application for CALDOLOR (ibuprofen) from Cumberland Pharmaceuticals Inc., authorizing changes to its labeli…

• FDA approval · 2015-01-20
  FDA Approved: FENTANYL CITRATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for fentanyl citrate submitted by Hikma Pharmaceuticals USA Inc., resulting in updated regulatory ap…

• FDA approval · 2014-08-13
  FDA Approved: EXPAREL — Supplemental Application (Pacira Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for EXPAREL (bupivacaine) submitted by Pacira Pharmaceuticals, Inc.

• FDA approval · 2014-08-04
  FDA Approved: KETOROLAC TROMETHAMINE — Original Application (Onesource Specialty Pharma Limited)

  FDA approved the original generic application for ketorolac tromethamine from Onesource Specialty Pharma Limited.

• FDA approval · 2014-04-21
  FDA Approved: SPRIX — Supplemental Application (Zyla Life Sciences US LLC)

  The FDA approved a supplemental application for SPRIX (ketorolac tromethamine) by Zyla Life Sciences US LLC, expanding its approved uses.

• FDA approval · 2014-02-13
  FDA Approved: ILEVRO — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for ILEVRO (nepafenac) from Novartis Pharmaceuticals Corporation. The supplemental action relates to…

• FDA approval · 2013-07-10
  FDA Approved: EXPAREL — Supplemental Application (Pacira Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for EXPAREL (bupivacaine) from Pacira Pharmaceuticals.

• FDA approval · 2013-03-28
  FDA Approved: KETOROLAC TROMETHAMINE — Supplemental Application (Apotex Corp.)

  FDA approved Apotex Corp.'s supplemental application for ketorolac tromethamine, a generic NSAID, to support its use in short-term managemen…

• FDA approval · 2012-10-16
  FDA Approved: ILEVRO — Original Application (Novartis Pharmaceuticals Corporation)

  FDA approved ILEVRO (nepafenac) from Novartis Pharmaceuticals Corporation as the original application for reducing postoperative pain and in…

• FDA approval · 2012-09-05
  FDA Approved: KETOROLAC TROMETHAMINE — Supplemental Application (Onesource Specialty Pharma Limited)

  FDA approved a supplemental application for ketorolac tromethamine from Onesource Specialty Pharma Limited. This action updates the approval…

• FDA approval · 2011-10-28
  FDA Approved: EXPAREL — Original Application (Pacira Pharmaceuticals, Inc.)

  FDA approves EXPAREL (bupivacaine liposome injectable suspension) from Pacira Pharmaceuticals in its original application, for postoperative…

• FDA approval · 2011-07-15
  FDA Approved: MORPHINE SULFATE — Original Application (SpecGx LLC)

  FDA approved the Original Application for Morphine Sulfate from SpecGx LLC, granting a generic version market authorization and confirming i…

• FDA approval · 2010-05-14
  FDA Approved: SPRIX — Original Application (Zyla Life Sciences US LLC)

  FDA approved SPRIX (ketorolac tromethamine) from Zyla Life Sciences US LLC through an Original Application, authorizing a short-term analges…

• FDA approval · 2009-11-09
  FDA Approved: FENTANYL CITRATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA has approved a supplemental application for fentanyl citrate by Teva Pharmaceuticals USA, Inc., marking an approved modification to …

• FDA approval · 2009-11-05
  FDA Approved: KETOROLAC TROMETHAMINE — Original Application (Apotex Corp.)

  FDA approved Ketorolac Tromethamine from Apotex Corp. under an original ANDA, enabling a generic version of this analgesic. It is indicated …

• FDA approval · 2009-06-11
  FDA Approved: CALDOLOR — Original Application (Cumberland Pharmaceuticals Inc.)

  FDA approved CALDOLOR (intravenous ibuprofen) under an original NDA for short-term management of postoperative pain in adults.

• FDA approval · 2008-10-06
  FDA Approved: KETOROLAC TROMETHAMINE — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved Sun Pharmaceutical Industries' ketorolac tromethamine as a generic injectable NSAID for short-term management of acute pain.

• FDA approval · 2008-03-17
  FDA Approved: MORPHINE SULFATE — Original Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved Morphine Sulfate under Hikma Pharmaceuticals USA Inc.'s Original Application (NDA 022195), authorizing the marketing of thi…

• FDA approval · 2007-06-19
  FDA Approved: KETOROLAC TROMETHAMINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved Teva's supplemental application for ketorolac tromethamine, a generic NSAID.