Diabetic Peripheral Neuropathic 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 · 2025-07-01
  FDA Approved: PREGABALIN CAPSULES, CV — Supplemental Application (Cipla USA Inc.)

  FDA approved a supplemental application for Pregabalin Capsules, CV from Cipla USA Inc., under ANDA to market this generic pregabalin capsul…

• 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…

• CLINICAL_TRIALS approval · 2025-01-10
  Clinical Trial Update: Duloxetine Compassionate Use in Patients Who Have Completed a Previous Neuroscience Duloxetine Clinical Trial

  Clinical trial update indicates that duloxetine, sponsored by Eli Lilly, has been approved for marketing in relation to a compassionate-use …

• 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…

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• 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 · 2023-05-02
  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 · 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 · 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 · 2020-12-30
  FDA Approved: DULOXETINE — Supplemental Application (Camber Pharmaceuticals, Inc.)

  The FDA approved Camber Pharmaceuticals' supplemental application for duloxetine (ANDA204343), enabling the continued marketing of the gener…

• 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.

• FDA approval · 2020-04-20
  FDA Approved: CYMBALTA — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application for Cymbalta (duloxetine hydrochloride) from Eli Lilly, granting updated labeling under the NDA.

• FDA approval · 2019-08-16
  FDA Approved: DULOXETINE HYDROCHLORIDE — Original Application (Yaopharma Co., Ltd.)

  FDA approved the original application for duloxetine hydrochloride from Yaopharma Co., Ltd., granting approval for the generic product to be…

• FDA approval · 2018-07-19
  FDA Approved: DULOXETINE — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' supplemental ANDA for a generic duloxetine product (ANDA204343). Duloxetine is indicated for major depr…

• FDA approval · 2017-04-06
  FDA Approved: DULOXETINE — Supplemental Application (Zydus Lifesciences Limited)

  The FDA approved a supplemental application for duloxetine submitted by Zydus Lifesciences Limited, advancing the regulatory status of the g…

• FDA approval · 2017-03-23
  FDA Approved: DULOXETINE HYDROCHLORIDE — Original Application (Macleods Pharmaceuticals Limited)

  FDA approved the original application for duloxetine hydrochloride from Macleods Pharmaceuticals Limited, authorizing a generic version of d…

• FDA approval · 2017-01-04
  FDA Approved: CYMBALTA — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application for Cymbalta (duloxetine hydrochloride) from Eli Lilly and Company.

• FDA approval · 2016-08-03
  FDA Approved: DULOXETINE — Original Application (Camber Pharmaceuticals, Inc.)

  The FDA approved Camber Pharmaceuticals' original application for a generic duloxetine product. Duloxetine is used to treat multiple conditi…

• FDA approval · 2015-08-26
  FDA Approved: DULOXETINE — Original Application (Ascend Laboratories, LLC)

  The FDA approved Ascend Laboratories' original application for a generic duloxetine product (ANDA 203197), establishing a generic version of…

• FDA approval · 2014-09-26
  FDA Approved: DULOXETINE — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for duloxetine from Zydus Lifesciences Limited under an ANDA. The approval involves changes to the a…

• FDA approval · 2014-06-09
  FDA Approved: DULOXETINE HYDROCHLORIDE — Original Application (Alembic Pharmaceuticals Limited)

  FDA approved Alembic Pharmaceuticals Limited's original ANDA for duloxetine hydrochloride, establishing a generic version of duloxetine.

• FDA approval · 2014-01-08
  FDA Approved: DULOXETINE — Original Application (Zydus Lifesciences Limited)

  FDA approved the original application for a duloxetine generic from Zydus Lifesciences Limited, enabling marketing for the same indications …

• FDA approval · 2013-12-17
  FDA Approved: DULOXETINE — Original Application (Actavis Pharma, Inc.)

  FDA approved Actavis Pharma, Inc.'s original application for a generic duloxetine product. The approval makes low-cost generic duloxetine av…

• FDA approval · 2013-12-11
  FDA Approved: DULOXETINE — Original Application (Aurobindo Pharma Limited)

  FDA approved the original application for a generic duloxetine hydrochloride product from Aurobindo Pharma Limited.

• FDA approval · 2013-12-11
  FDA Approved: DULOXETINE — Original Application (MARKSANS PHARMA LIMITED)

  FDA approves duloxetine hydrochloride generic by Marksans Pharma Limited under an Original ANDA (ANDA 090723).