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• 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 · 2017-05-18
  FDA Approved: DULOXETINE — Original Application (Solco Healthcare US, LLC)

  FDA approved Solco Healthcare US, LLC's original application for duloxetine, enabling the marketing of a generic duloxetine product.

• 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 · 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…

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• 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 · 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 (Sun Pharmaceutical Industries, Inc.)

  FDA approves Sun Pharmaceutical Industries' original application for a generic duloxetine product (DULOXETINE). This approval allows the mar…

• FDA approval · 2013-04-11
  FDA Approved: CYCLOBENZAPRINE HYDROCHLORIDE — Supplemental Application (Jubilant Cadista Pharmaceuticals Inc.)

  The FDA approved a supplemental application for cyclobenzaprine hydrochloride (generic) from Jubilant Cadista Pharmaceuticals, approving an …

• FDA approval · 2011-04-12
  FDA Approved: CYMBALTA — Supplemental Application (Eli Lilly and Company)

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