Cancer Pain

• FDA approval · 2015-09-10
  FDA Approved: OXYCONTIN — Supplemental Application (Purdue Pharma LP)

  FDA approved a supplemental application for OXYCONTIN (oxycodone hydrochloride) submitted by Purdue Pharma LP.

• FDA approval · 2015-06-26
  FDA Approved: FENTANYL TRANSDERMAL — Supplemental Application (SpecGx LLC)

  FDA approved a supplemental application for fentanyl transdermal submitted by SpecGx LLC.

• FDA approval · 2015-06-26
  FDA Approved: FENTANYL — Supplemental Application (Aveva Drug Delivery Systems Inc.)

  FDA approved a supplemental application for fentanyl submitted by Aveva Drug Delivery Systems Inc., under ANDA 077449.

• FDA approval · 2015-06-11
  FDA Approved: FENTANYL TRANSDERMAL — Supplemental Application (SpecGx LLC)

  FDA approved a supplemental application for Fentanyl Transdermal filed by SpecGx LLC.

• 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…

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• FDA approval · 2014-08-19
  FDA Approved: FENTANYL TRANSDERMAL — Supplemental Application (SpecGx LLC)

  FDA approved a supplemental application for fentanyl transdermal patch from SpecGx LLC, resulting in approval of an additional generic produ…

• FDA approval · 2014-06-16
  FDA Approved: FENTANYL TRANSDERMAL — Supplemental Application (SpecGx LLC)

  FDA approved a supplemental application for fentanyl transdermal submitted by SpecGx LLC, resulting in a regulatory update for the product.

• FDA approval · 2014-04-16
  FDA Approved: MS CONTIN — Supplemental Application (Rhodes Pharmaceuticals L.P.)

  The FDA approved a supplemental application for MS CONTIN (morphine sulfate) filed by Rhodes Pharmaceuticals L.P., signaling an update relat…

• FDA approval · 2014-02-04
  FDA Approved: OXYCONTIN — Supplemental Application (Purdue Pharma LP)

  FDA approved a supplemental application for OXYCONTIN (oxycodone hydrochloride) submitted by Purdue Pharma LP.

• FDA approval · 2013-04-19
  FDA Approved: FENTANYL — Supplemental Application (Aveva Drug Delivery Systems Inc.)

  FDA approved a supplemental application for fentanyl submitted by Aveva Drug Delivery Systems, indicating approval of a revised fentanyl del…

• FDA approval · 2013-04-15
  FDA Approved: MS CONTIN — Supplemental Application (Rhodes Pharmaceuticals L.P.)

  The FDA approved a supplemental application for MS CONTIN (morphine sulfate) from Rhodes Pharmaceuticals L.P.

• FDA approval · 2013-02-14
  FDA Approved: FENTANYL — Supplemental Application (Aveva Drug Delivery Systems Inc.)

  FDA approved a supplemental application for fentanyl submitted by Aveva Drug Delivery Systems Inc., updating the marketing authorization for…

• FDA approval · 2013-01-16
  FDA Approved: MORPHINE SULFATE — Original Application (Actavis Pharma, Inc.)

  FDA approved Morphine Sulfate as an original generic ANDA for Actavis Pharma, enabling a generic formulation for pain management.

• FDA approval · 2012-09-28
  FDA Approved: MORPHINE SULFATE EXTENDED RELEASE — Supplemental Application (Rhodes Pharmaceuticals L. P.)

  The FDA approved a supplemental application for Morphine Sulfate Extended Release from Rhodes Pharmaceuticals L.P., updating labeling to sup…

• FDA approval · 2012-07-09
  FDA Approved: OXYCONTIN — Supplemental Application (Purdue Pharma LP)

  The FDA approved a supplemental application for OxyContin (oxycodone hydrochloride) submitted by Purdue Pharma LP.

• FDA approval · 2012-01-25
  FDA Approved: OXYCODONE HYDROCHLORIDE — Supplemental Application (Genus Lifesciences Inc.)

  FDA approved a supplemental application for oxycodone hydrochloride filed by Genus Lifesciences Inc.

• 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 · 2011-02-09
  FDA Approved: FENTANYL TRANSDERMAL — Original Application (SpecGx LLC)

  FDA approved a fentanyl transdermal patch as a generic product under an Original Application (ANDA 077154) for use in opioid-tolerant adults…

• FDA approval · 2010-04-05
  FDA Approved: OXYCONTIN — Original Application (Purdue Pharma LP)

  The FDA approved the original application for OxyContin (oxycodone hydrochloride) by Purdue Pharma LP for relief of moderate to severe pain.

• 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 · 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 · 2007-01-23
  FDA Approved: FENTANYL — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA has approved a supplemental application for a fentanyl generic product from Mylan Pharmaceuticals Inc.