Pain

• FDA approval · 2025-10-10
  FDA Approved: OXYMORPHONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for oxymorphone hydrochloride from Hikma Pharmaceuticals USA, authorizing a generic product.

• FDA approval · 2025-09-26
  FDA Approved: HYDROCODONE BITARTRATE — Supplemental Application (Alvogen Inc.)

  FDA approved a supplemental application for hydrocodone bitartrate from Alvogen Inc. under an approved generic drug filing (ANDA).

• FDA approval · 2025-07-29
  FDA Approved: BUPRENORPHINE HYDROCHLORIDE — Supplemental Application (Par Health USA, LLC)

  FDA approved a supplemental application for buprenorphine hydrochloride from Par Health USA, LLC, indicating approval of a generic product u…

• FDA approval · 2025-07-29
  FDA Approved: VYSCOXA — Original Application (Carwin Pharmaceutical Associates, LLC)

  FDA approved VYSCOXA, a brand name for celecoxib, under Carwin Pharmaceutical Associates, LLC's original application. This confirms marketin…

• FDA approval · 2025-06-25
  FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for methadone hydrochloride (generic) from Hikma Pharmaceuticals USA Inc., updating an approved prod…

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• FDA approval · 2025-05-05
  FDA Approved: METHADONE HYDROCHLORIDE — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approves the original application for Methadone Hydrochloride generic from Hikma Pharmaceuticals USA Inc., enabling a new generic formul…

• FDA approval · 2025-03-10
  FDA Approved: ACETAMINOPHEN AND CODEINE PHOSPHATE — Supplemental Application (SpecGx LLC)

  The FDA approved a supplemental application for Acetaminophen and Codeine Phosphate submitted by SpecGx LLC, likely enabling changes to labe…

• FDA approval · 2025-03-05
  FDA Approved: HYDROCODONE BITARTRATE AND ACETAMINOPHEN — Supplemental Application (Strides Pharma Science Limited)

  FDA approved a supplemental application for hydrocodone bitartrate and acetaminophen from Strides Pharma Science Limited. The action represe…

• FDA approval · 2025-03-05
  FDA Approved: ACETAMINOPHEN AND CODEINE — Supplemental Application (Amneal Pharmaceuticals LLC)

  The FDA approved Amneal Pharmaceuticals LLC's supplemental application for acetaminophen and codeine, approving a generic combination analge…

• FDA approval · 2025-02-26
  FDA Approved: CELECOXIB — Supplemental Application (Apotex Corp.)

  FDA approved Apotex Corp.'s supplemental application for Celecoxib (celecoxib), authorizing a generic version under the ANDA pathway. The ac…

• FDA approval · 2025-02-21
  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 (PAI Holdings) under an ANDA, reflecting an updated or additional fo…

• FDA approval · 2025-02-21
  FDA Approved: BUPRENORPHINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for buprenorphine submitted by Sun Pharmaceutical Industries, Inc.

• FDA approval · 2025-02-21
  FDA Approved: BUPRENORPHINE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for buprenorphine from Hikma Pharmaceuticals USA Inc. under the approved ANDA.

• FDA approval · 2025-02-11
  FDA Approved: HYDROCODONE BITARTRATE AND ACETAMINOPHEN — Supplemental Application (SpecGx LLC)

  The FDA granted supplemental approval for a generic hydrocodone bitartrate and acetaminophen product (SpecGx LLC).

• FDA approval · 2025-01-31
  FDA Approved: TRAMADOL HYDROCHLORIDE — Original Application (Macleods Pharmaceuticals Limited)

  FDA approved Macleods Pharmaceuticals Limited's original ANDA for tramadol hydrochloride (generic tramadol) for pain relief.

• FDA approval · 2024-12-19
  FDA Approved: CELECOXIB — Supplemental Application (Aurobindo Pharma Limited)

  FDA supplemental approval for Aurobindo Pharma Limited's generic celecoxib.

• FDA approval · 2024-11-21
  FDA Approved: KETOROLAC TROMETHAMINE — Supplemental Application (Fresenius Kabi USA, LLC)

  The FDA approved a supplemental application for ketorolac tromethamine from Fresenius Kabi USA, LLC, indicating clearance of a modification …

• FDA approval · 2024-11-21
  FDA Approved: KETOROLAC TROMETHAMINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for Ketorolac Tromethamine from Teva Pharmaceuticals USA, Inc., under an ANDA to update the approved…

• FDA approval · 2024-11-21
  FDA Approved: HYDROCODONE BITARTRATE AND IBUPROFEN — Supplemental Application (Aurolife Pharma, LLC)

  FDA approved a supplemental application for Hydrocodone Bitartrate and Ibuprofen from Aurolife Pharma, LLC.

• FDA approval · 2024-11-21
  FDA Approved: KETOROLAC TROMETHAMINE — Supplemental Application (Hospira, Inc.)

  FDA approves Hospira's supplemental application for ketorolac tromethamine, a generic NSAID. The approval pertains to a supplemental change …

• FDA approval · 2024-11-21
  FDA Approved: KETOROLAC TROMETHAMINE — Supplemental Application (Chartwell RX, LLC)

  The FDA approved Chartwell RX, LLC's supplemental application for ketorolac tromethamine (ANDA210616), confirming changes to the approved ge…

• FDA approval · 2024-11-21
  FDA Approved: OXYCODONE AND ASPIRIN — Supplemental Application (Epic Pharma, LLC)

  FDA approved a supplemental application for the Oxycodone and aspirin combination analgesic from Epic Pharma, LLC.

• FDA approval · 2024-11-21
  FDA Approved: DICLOFENAC SODIUM — Supplemental Application (NorthStar Rx LLC)

  FDA approved a supplemental application for a generic diclofenac sodium product from NorthStar Rx LLC.

• FDA approval · 2024-11-21
  FDA Approved: KETOROLAC TROMETHAMINE — Supplemental Application (Eugia US LLC)

  FDA approved a supplemental application for Ketorolac tromethamine (generic) from Eugia US LLC under ANDA 212939.

• FDA approval · 2024-11-21
  FDA Approved: KETOROLAC TROMETHAMINE — Supplemental Application (Civica, Inc.)

  FDA approved a supplemental application for Civica's ketorolac tromethamine product, enabling a generic approval.