Pain

• FDA approval · 2024-03-06
  FDA Approved: ACETAMINOPHEN AND CODEINE PHOSPHATE — Supplemental Application (Aurolife Pharma, LLC)

  FDA approved a supplemental application for Acetaminophen and Codeine Phosphate manufactured by Aurolife Pharma, LLC.

• FDA approval · 2024-03-04
  FDA Approved: OXYCODONE AND ACETAMINOPHEN — Supplemental Application (SpecGx LLC)

  FDA approved a supplemental application for an oxycodone hydrochloride and acetaminophen product submitted by SpecGx LLC.

• FDA approval · 2024-02-28
  FDA Approved: OXYCODONE AND ACETAMINOPHEN — Supplemental Application (Epic Pharma, LLC)

  The FDA approved a supplemental application for the oxycodone and acetaminophen product from Epic Pharma, LLC.

• FDA approval · 2024-02-27
  FDA Approved: HYDROCODONE BITARTRATE AND ACETAMINOPHEN — Supplemental Application (PAI Holdings, LLC dba PAI Pharma)

  The FDA approved a supplemental application for Hydrocodone Bitartrate and Acetaminophen by PAI Holdings, LLC dba PAI Pharma under ANDA 0408…

• FDA approval · 2024-02-27
  FDA Approved: HYDROCODONE BITARTRATE AND ACETAMINOPHEN — Supplemental Application (Eywa Pharma Inc)

  FDA approved Eywa Pharma Inc's supplemental application for Hydrocodone Bitartrate and Acetaminophen.

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2024-02-26
  FDA Approved: OXYCODONE AND ACETAMINOPHEN — Supplemental Application (Epic Pharma, LLC)

  The FDA granted supplemental approval for a generic oxycodone/acetaminophen product from Epic Pharma, LLC.

• FDA approval · 2024-02-09
  FDA Approved: HYDROMORPHONE HYDROCHLORIDE — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approves a generic hydromorphone hydrochloride product (original application) from Hikma Pharmaceuticals USA Inc. for relief of moderate…

• FDA approval · 2024-02-01
  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.

• FDA approval · 2024-01-26
  FDA Approved: SUFENTANIL CITRATE — Supplemental Application (Hospira, Inc.)

  The FDA approved Hospira's supplemental application for sufentanil citrate, finalizing an additional regulatory action for this generic opio…

• FDA approval · 2024-01-16
  FDA Approved: BUTORPHANOL TARTRATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for butorphanol tartrate by Hikma Pharmaceuticals USA Inc. (ANDA 078400). This action confirms conti…

• FDA approval · 2024-01-12
  FDA Approved: HYDROCODONE BITARTRATE AND ACETAMINOPHEN — Supplemental Application (Epic Pharma, LLC)

  FDA approved a supplemental application for Hydrocodone Bitartrate and Acetaminophen by Epic Pharma, LLC, under ANDA 203863. This approves a…

• FDA approval · 2024-01-09
  FDA Approved: PROLATE — Supplemental Application (Forte Bio-Pharma LLC)

  FDA approved a supplemental application for PROLATE, a generic oxycodone hydrochloride and acetaminophen tablet, for Forte Bio-Pharma LLC.

• FDA approval · 2024-01-03
  FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (SpecGx LLC)

  FDA approved a supplemental application for Methadone hydrochloride from SpecGx LLC, approving changes to an existing generic product under …

• FDA approval · 2024-01-03
  FDA Approved: PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE — Supplemental Application (Lupin Pharmaceuticals,Inc.)

  FDA approved a supplemental application for the Pentazocine Hydrochloride and Naloxone Hydrochloride combination from Lupin Pharmaceuticals,…

• FDA approval · 2024-01-03
  FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (SpecGx LLC)

  FDA approved a supplemental application for methadone hydrochloride (SpecGx LLC), finalizing an updated regulatory authorization under an AN…

• FDA approval · 2024-01-03
  FDA Approved: OXYCODONE AND ACETAMINOPHEN — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved a supplemental application for the generic oxycodone/acetaminophen product from Amneal Pharmaceuticals of New York LLC.

• FDA approval · 2023-12-31
  FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (SpecGx LLC)

  The FDA approved a supplemental application for methadone hydrochloride submitted by SpecGx LLC.

• FDA approval · 2023-12-18
  FDA Approved: HYDROCODONE BITARTRATE AND IBUPROFEN — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved a supplemental application for HYDROCODONE BITARTRATE AND IBUPROFEN (Amneal Pharmaceuticals of New York LLC), authorizing its m…

• FDA approval · 2023-12-15
  FDA Approved: DISKETS — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for DISKETS (methadone hydrochloride) from Hikma Pharmaceuticals USA Inc., indicating an approve…

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

  FDA approved a supplemental application for Methadose (methadone hydrochloride) submitted by SpecGx LLC.

• FDA approval · 2023-12-15
  FDA Approved: MEPERIDINE HYDROCHLORIDE — Supplemental Application (Genus Lifesciences Inc.)

  The FDA approved Genus Lifesciences Inc.'s supplemental application for Meperidine Hydrochloride (ANDA 040893), a generic opioid analgesic. …

• FDA approval · 2023-12-15
  FDA Approved: BUPRENORPHINE HYDROCHLORIDE — Supplemental Application (PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma)

  FDA approved a supplemental application for buprenorphine hydrochloride (ANDA 090622) from PAI Holdings/PAI Pharma, confirming the approval …

• FDA approval · 2023-12-15
  FDA Approved: HYDROCODONE BITARTRATE AND ACETAMINOPHEN — Supplemental Application (Genus Lifesciences Inc.)

  FDA approved a supplemental application for Genus Lifesciences Inc.'s generic hydrocodone bitartrate and acetaminophen product. The action c…

• FDA approval · 2023-12-15
  FDA Approved: TRAMADOL HYDROCHLORIDE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental application for tramadol hydrochloride, granting approval of a generic tramadol hydrochlori…

• FDA approval · 2023-12-15
  FDA Approved: TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN — Supplemental Application (Micro Labs Limited)

  The FDA approved a supplemental ANDA for Micro Labs Limited to market a tramadol hydrochloride and acetaminophen combination as a generic an…