Musculoskeletal Pain

• FDA approval · 2026-04-09
  FDA Approved: DULOXETINE HYDROCHLORIDE — Supplemental Application (Alembic Pharmaceuticals Limited)

  FDA approves a supplemental application for duloxetine hydrochloride as a generic product from Alembic Pharmaceuticals Limited.

• FDA approval · 2025-03-28
  FDA Approved: DULOXETINE DELAYED-RELEASE — Supplemental Application (Breckenridge Pharmaceutical, Inc.)

  The FDA approved Breckenridge Pharmaceutical's supplemental ANDA for a duloxetine hydrochloride delayed-release product, making a generic du…

• FDA approval · 2024-12-17
  FDA Approved: CYCLOBENZAPRINE HYDROCHLORIDE — Supplemental Application (Upsher-Smith Laboratories, LLC)

  The FDA approved Upsher-Smith Laboratories’ supplemental application for cyclobenzaprine hydrochloride, enabling changes to the product labe…

• FDA approval · 2024-11-21
  FDA Approved: NORGESIC — Supplemental Application (Galt Pharmaceuticals, LLC)

  The FDA approved a supplemental application for NORGESIC, a combination of orphenadrine citrate, aspirin, and caffeine, manufactured by Galt…

• FDA approval · 2024-11-21
  FDA Approved: FLECTOR — Supplemental Application (IBSA Pharma Inc.)

  FDA approved a supplemental application for FLECTOR (diclofenac epolamine) submitted by IBSA Pharma Inc.

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• FDA approval · 2024-09-12
  FDA Approved: CYCLOBENZAPRINE HYDROCHLORIDE — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved the original application for cyclobenzaprine hydrochloride (generic) from Rising Pharma Holdings, Inc. for relief of muscle spa…

• FDA approval · 2024-08-14
  FDA Approved: ORPHENADRINE CITRATE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental application for Orphenadrine citrate, enabling a new generic version of the muscle relaxant…

• FDA approval · 2024-04-25
  FDA Approved: CYCLOBENZAPRINE HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved a supplemental application for cyclobenzaprine hydrochloride submitted by Amneal Pharmaceuticals of New York LLC.

• FDA approval · 2023-12-19
  FDA Approved: DULOXETINE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for duloxetine hydrochloride from Aurobindo Pharma Limited, granting regulatory clearance for a gene…

• FDA approval · 2023-08-18
  FDA Approved: DRIZALMA SPRINKLE — Supplemental Application (SUN PHARMACEUTICAL INDUSTRIES, INC.)

  The FDA approved Sun Pharmaceutical's supplemental NDA for Drizalma Sprinkle (duloxetine), adding a sprinkle-form formulation and related la…

• FDA approval · 2023-08-17
  FDA Approved: CHLORZOXAZONE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Chlorzoxazone submitted by Aurobindo Pharma Limited.

• FDA approval · 2023-08-09
  FDA Approved: CHLORZOXAZONE — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved Rising Pharma's original ANDA for chlorzoxazone (generic) as a muscle relaxant to relieve muscle spasm associated with acute mu…

• FDA approval · 2023-05-02
  FDA Approved: DULOXETINE — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application from Actavis Pharma, Inc. for duloxetine under ANDA 090776, granting approval for a supplemental cha…

• FDA approval · 2023-05-02
  FDA Approved: DULOXETINE — Supplemental Application (Solco Healthcare US, LLC)

  The FDA approved a supplemental application for duloxetine submitted by Solco Healthcare US, LLC (ANDA206653), authorizing a change related …

• FDA approval · 2023-04-10
  FDA Approved: CHLORZOXAZONE — Original Application (Lifsa Drugs LLC)

  The FDA approved Lifsa Drugs LLC's chlorzoxazone under ANDA214702 as an original application for a generic product.

• FDA approval · 2023-02-09
  FDA Approved: METHOCARBAMOL — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for methocarbamol from Aurobindo Pharma Limited.

• FDA approval · 2022-07-29
  FDA Approved: DULOXETINE — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  FDA approved a supplemental application for duloxetine filed by Quallent Pharmaceuticals Health LLC.

• FDA approval · 2022-07-26
  FDA Approved: DULOXETINE — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  The FDA approved a supplemental application for DULOXETINE submitted by Quallent Pharmaceuticals Health LLC. The notice confirms regulatory …

• FDA approval · 2022-07-15
  FDA Approved: METHOCARBAMOL — Supplemental Application (Trifluent Pharma LLC)

  The FDA approved a supplemental application for Methocarbamol filed by Trifluent Pharma LLC. This action updates the regulatory status of Me…

• FDA approval · 2022-04-05
  FDA Approved: CHLORZOXAZONE — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved the original application for chlorzoxazone (a generic muscle relaxant) from Rising Pharma Holdings, Inc.

• FDA approval · 2022-01-25
  FDA Approved: DULOXETINE — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for a generic duloxetine hydrochloride product from Aurobindo Pharma Limited.

• FDA approval · 2021-10-20
  FDA Approved: CARISOPRODOL TABLETS, USP, 350 MG — Original Application (Granulation Technology, Inc.)

  The FDA approved an original ANDA for Carisoprodol Tablets, USP, 350 mg, establishing a generic version of the muscle relaxant for short-ter…

• FDA approval · 2021-07-29
  FDA Approved: CHLORZOXAZONE — Original Application (Happy Robin, LLC)

  FDA approved a generic chlorzoxazone product under an original ANDA from Happy Robin, LLC.

• FDA approval · 2021-07-23
  FDA Approved: DRIZALMA SPRINKLE — Supplemental Application (SUN PHARMACEUTICAL INDUSTRIES, INC.)

  The FDA approved a supplemental application for Drizalma Sprinkle, a duloxetine product, expanding the label to include a sprinkle-form dosa…

• FDA approval · 2021-04-28
  FDA Approved: FLECTOR — Supplemental Application (IBSA Pharma Inc.)

  FDA approved a supplemental application for FLECTOR (diclofenac epolamine) submitted by IBSA Pharma Inc.