Back Pain

• FDA approval · 2025-10-22
  FDA Approved: GOOD SENSE DUAL ACTION BACK PAIN — Supplemental Application (L. Perrigo Company)

  FDA approved a supplemental application for GOOD SENSE DUAL ACTION BACK PAIN, a combination product containing acetaminophen and ibuprofen f…

• FDA approval · 2024-03-26
  FDA Approved: ACETAMINOPHEN AND IBUPROFEN BACK PAIN — Original Application (Aurohealth LLC)

  FDA approved a generic acetaminophen and ibuprofen product for back pain under an original application by Aurohealth LLC.

• FDA approval · 2023-02-28
  FDA Approved: GOOD SENSE DUAL ACTION BACK PAIN — Original Application (L. Perrigo Company)

  FDA approves L. Perrigo's Good Sense Dual Action Back Pain, a generic combination of acetaminophen and ibuprofen, under an Original Applicat…

• FDA approval · 2022-05-31
  FDA Approved: IBUPROFEN PM — Original Application (KROGER COMPANY)

  FDA approved Kroger's Ibuprofen PM, an over-the-counter combination product containing ibuprofen and diphenhydramine citrate, under an origi…

• FDA approval · 2020-10-01
  FDA Approved: CYMBALTA — Supplemental Application (Eli Lilly and Company)

  FDA approves a supplemental application for Cymbalta (duloxetine hydrochloride) submitted by Eli Lilly and Company.

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• FDA approval · 2016-03-15
  FDA Approved: ADVIL PM- DIPHENHYDRAMINE CITRATE AND IBUPROFEN TABLET, COATED — Supplemental Application (Lil Drug Store Products, Inc)

  FDA approved a supplemental application for Advil PM tablets (ibuprofen and diphenhydramine citrate), expanding labeling to include this com…

• FDA approval · 2015-10-28
  FDA Approved: ALEVE PM — Supplemental Application (Bayer HealthCare LLC.)

  FDA approved a supplemental application for ALEVE PM (diphenhydramine hydrochloride and naproxen sodium) to support its continued marketing …

• FDA approval · 2013-04-18
  FDA Approved: ALEVE GELCAPS — Supplemental Application (Bayer HealthCare LLC.)

  FDA approves a supplemental application for Aleve GelCaps to expand labeling for naproxen sodium, broadening indications for pain relief.

• CLINICAL_TRIALS approval · 2012-03-05
  Clinical Trial Update: Prometra's Utilization in Mitigating Pain II

  Prometra intrathecal drug-delivery system received marketing approval to treat intractable pain, including back, leg, arm, and trunk pain.

• FDA approval · 2008-02-20
  FDA Approved: SALONPAS PAIN RELIEF — Original Application (Hisamitsu Pharmaceutical Co., Inc.)

  The FDA approved the original application for SALONPAS PAIN RELIEF by Hisamitsu, a topical analgesic patch containing menthol and methyl sal…