Pain

• FDA label_change · 2024-10-31
  FDA Approved: XTAMPZA ER — Supplemental Application (Collegium Pharmaceutical, Inc.)

  The FDA approved a supplemental application for XTAMPZA ER (oxycodone) from Collegium Pharmaceutical to update the product labeling. XTAMPZA…

• FDA label_change · 2023-12-15
  FDA Approved: NALBUPHINE HYDROCHLORIDE — Supplemental Application (Hospira, Inc.)

  FDA approved a supplemental application for nalbuphine hydrochloride by Hospira, updating labeling for this generic analgesic.

• FDA label_change · 2023-12-01
  FDA Approved: NALBUPHINE HYDROCHLORIDE — Supplemental Application (Hospira, Inc.)

  FDA approved a supplemental application for nalbuphine hydrochloride submitted by Hospira, resulting in changes to the product labeling.

• FDA label_change · 2023-11-30
  FDA Approved: TRAMADOL HYDROCHLORIDE — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved a supplemental application for tramadol hydrochloride from Unichem Pharmaceuticals (USA), Inc., indicating a change to the appr…

• FDA label_change · 2022-01-11
  FDA Approved: ADVIL PM — Supplemental Application (Haleon US Holdings LLC)

  The FDA approved a supplemental labeling application for Advil PM, a combination product of diphenhydramine HCl and ibuprofen, by Haleon US …

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• FDA label_change · 2021-04-28
  FDA Approved: KETOROLAC TROMETHAMINE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Ketorolac tromethamine from Hikma Pharmaceuticals USA Inc., updating the labeling of the product…

• FDA label_change · 2019-10-11
  FDA Approved: BUTORPHANOL TARTRATE — Supplemental Application (Hospira, Inc.)

  FDA approves a supplemental application for butorphanol tartrate from Hospira, indicating changes to the product labeling for the generic.

• FDA label_change · 2019-10-07
  FDA Approved: BUTRANS — Supplemental Application (Purdue Pharma LP)

  FDA approved a supplemental application for Butrans (buprenorphine) submitted by Purdue Pharma L.P. The approval may involve changes to the …

• FDA label_change · 2019-10-07
  FDA Approved: DISKETS — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for DISKETS (methadone hydrochloride) by Hikma Pharmaceuticals USA Inc., indicating a change to the …

• FDA label_change · 2019-10-07
  FDA Approved: MORPHINE SULFATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA documents a supplemental application for Morphine Sulfate by Hikma Pharmaceuticals USA Inc., likely related to labeling changes for the …

• FDA label_change · 2016-12-16
  FDA Approved: MORPHINE SULFATE — Supplemental Application (Hospira, Inc.)

  The FDA approved a supplemental application for Morphine Sulfate by Hospira, Inc., resulting in changes to the drug's labeling.

• FDA label_change · 2016-05-10
  FDA Approved: HYDROCODONE BITARTRATE AND ACETAMINOPHEN — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application for Hydrocodone Bitartrate and Acetaminophen from Amneal Pharmaceuticals LLC, indicating a labeling …

• FDA label_change · 2013-01-11
  FDA Approved: OXYCONTIN — Supplemental Application (Purdue Pharma LP)

  The FDA approved a supplemental application for OxyContin (oxycodone hydrochloride) from Purdue Pharma to update the product labeling.

• FDA label_change · 2012-08-20
  FDA Approved: KETOROLAC TROMETHAMINE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental labeling application for ketorolac tromethamine (Toradol) from Mylan Pharmaceuticals, indicating a labeling upda…

• FDA label_change · 2007-11-30
  FDA Approved: ACETAMINOPHEN AND CODEINE PHOSPHATE — Supplemental Application (SpecGx LLC)

  FDA approved a supplemental application for Acetaminophen and Codeine Phosphate submitted by SpecGx LLC.