Cancer Pain

• FDA approval · 2025-12-22
  FDA Approved: MS CONTIN — Supplemental Application (Rhodes Pharmaceuticals L.P.)

  The FDA approved a supplemental application for MS CONTIN (morphine sulfate) submitted by Rhodes Pharmaceuticals L.P., resulting in an updat…

• FDA approval · 2025-12-22
  FDA Approved: MORPHINE SULFATE — Supplemental Application (Fresenius Kabi, USA LLC)

  FDA approved a supplemental application for Morphine Sulfate submitted by Fresenius Kabi, USA LLC.

• FDA approval · 2024-10-31
  FDA Approved: MORPHINE SULFATE — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for Actavis Pharma's morphine sulfate to market a generic morphine sulfate product. This action auth…

• FDA approval · 2024-10-31
  FDA Approved: MORPHINE SULFATE — Supplemental Application (Cranbury Pharmaceuticals, LLC)

  The FDA approved a supplemental application for morphine sulfate, submitted by Cranbury Pharmaceuticals, LLC.

• FDA approval · 2024-10-31
  FDA Approved: FENTANYL SYSTEM — Supplemental Application (ALVOGEN)

  FDA approved a supplemental application for the FENTANYL SYSTEM from ALVOGEN.

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• FDA approval · 2024-10-31
  FDA Approved: FENTANYL TRANSDERMAL — Supplemental Application (SpecGx LLC)

  FDA approved a supplemental application for fentanyl transdermal from SpecGx LLC. The approval represents a modification to the existing pro…

• FDA approval · 2023-12-15
  FDA Approved: FENTANYL TRANSDERMAL — Supplemental Application (SpecGx LLC)

  FDA approves a supplemental application for fentanyl transdermal patch manufactured by SpecGx LLC.

• FDA approval · 2023-12-14
  FDA Approved: HYDROMORPHONE HYDROCHLORIDE — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved hydromorphone hydrochloride from Hikma Pharmaceuticals USA Inc. under Original Application NDA217812 for pain management.

• FDA approval · 2023-12-11
  FDA Approved: FENTANYL SYSTEM — Supplemental Application (ALVOGEN)

  FDA approves ALVOGEN's Supplemental Application for the FENTANYL SYSTEM (fentanyl) under ANDA202097, granting a supplemental approval to the…

• FDA approval · 2023-12-08
  FDA Approved: FENTANYL TRANSDERMAL — Supplemental Application (SpecGx LLC)

  FDA issued a supplemental approval for fentanyl transdermal product submitted by SpecGx LLC.

• FDA approval · 2021-05-06
  FDA Approved: MITIGO — Supplemental Application (Piramal Critical Care, Inc.)

  FDA approved a supplemental submission for MITIGO (morphine sulfate) by Piramal Critical Care, Inc., approving changes to an existing morphi…

• FDA approval · 2018-09-18
  FDA Approved: FENTANYL TRANSDERMAL — Supplemental Application (SpecGx LLC)

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

• FDA approval · 2018-09-18
  FDA Approved: FENTANYL SYSTEM — Supplemental Application (ALVOGEN)

  FDA approved a supplemental application for the Fentanyl System by ALVOGEN, indicating continued authorization for this fentanyl transdermal…

• FDA approval · 2018-09-18
  FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Elite Laboratories, Inc.)

  FDA approved a supplemental application for Elite Laboratories' methadone hydrochloride (ANDA 210484), authorizing its continued marketing a…

• FDA approval · 2018-09-18
  FDA Approved: MORPHINE SULFATE EXTENDED RELEASE — Supplemental Application (Rhodes Pharmaceuticals L. P.)

  FDA approved a supplemental application for Morphine Sulfate Extended Release from Rhodes Pharmaceuticals L.P., updating the product under a…

• FDA approval · 2017-05-26
  FDA Approved: MORPHINE SULFATE — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for Morphine Sulfate from Actavis Pharma, Inc., permitting continued marketing of the generic produc…

• FDA approval · 2017-05-19
  FDA Approved: MORPHINE SULFATE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved a supplemental application for Morphine Sulfate by Amneal Pharmaceuticals of New York LLC under ANDA 200411, granting a supplem…

• FDA approval · 2016-12-16
  FDA Approved: MS CONTIN — Supplemental Application (Rhodes Pharmaceuticals L.P.)

  The FDA approved a supplemental application for MS CONTIN (morphine sulfate) submitted by Rhodes Pharmaceuticals L.P. This action confirms t…

• FDA approval · 2016-12-16
  FDA Approved: MORPHINE SULFATE — Supplemental Application (Fresenius Kabi, USA LLC)

  FDA has approved a supplemental application for Morphine Sulfate submitted by Fresenius Kabi, USA LLC under NDA204223.

• FDA approval · 2016-11-04
  FDA Approved: FENTANYL SYSTEM — Original Application (ALVOGEN)

  The FDA has approved ALVOGEN's FENTANYL SYSTEM as an original-application generic product.

• FDA approval · 2016-09-30
  FDA Approved: FENTANYL — Supplemental Application (Aveva Drug Delivery Systems Inc.)

  FDA approved a supplemental application for fentanyl submitted by Aveva Drug Delivery Systems Inc., reflecting an approved change to the pro…

• FDA approval · 2016-08-22
  FDA Approved: FENTANYL — Supplemental Application (Aveva Drug Delivery Systems Inc.)

  FDA approved a supplemental application for fentanyl submitted by Aveva Drug Delivery Systems Inc.

• FDA approval · 2016-04-20
  FDA Approved: FENTANYL — Supplemental Application (Aveva Drug Delivery Systems Inc.)

  The FDA approved a supplemental application for fentanyl from Aveva Drug Delivery Systems Inc., indicating regulatory action related to a ne…

• FDA approval · 2016-04-20
  FDA Approved: FENTANYL TRANSDERMAL — Supplemental Application (SpecGx LLC)

  FDA approved a supplemental application for FENTANYL TRANSDERMAL by SpecGx LLC, a generic fentanyl transdermal patch.

• FDA approval · 2015-09-11
  FDA Approved: FENTANYL — Supplemental Application (Aveva Drug Delivery Systems Inc.)

  FDA approved a supplemental application for fentanyl from Aveva Drug Delivery Systems Inc., granting approval for an additional formulation/…