Generalized Anxiety Disorder

• FDA approval · 2026-04-15
  FDA Approved: BUSPIRONE HYDROCHLORIDE — Supplemental Application (Oxford Pharmaceuticals, LLC)

  FDA approved a supplemental application for Buspirone hydrochloride from Oxford Pharmaceuticals, LLC, finalizing regulatory approval for thi…

• 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 · 2026-03-27
  FDA Approved: ESCITALOPRAM — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental application for a generic escitalopram product (ANDA 078169).

• FDA approval · 2026-03-26
  FDA Approved: PAROXETINE — Supplemental Application (Alembic Pharmaceuticals Inc.)

  The FDA approved Alembic Pharmaceuticals Inc.'s supplemental application for paroxetine (generic). This marks approval of a generic paroxeti…

• FDA approval · 2026-02-02
  FDA Approved: PREGABALIN — Supplemental Application (Tris Pharma Inc)

  FDA approves Tris Pharma Inc's supplemental application for pregabalin.

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• FDA approval · 2026-01-30
  FDA Approved: VENLAFAXINE HYDROCHLORIDE — Supplemental Application (Marlex Pharmaceuticals, Inc.)

  FDA approved a supplemental application for venlafaxine hydrochloride (ANDA201272) from Marlex Pharmaceuticals, Inc., authorizing continued …

• FDA approval · 2025-10-17
  FDA Approved: BUCAPSOL — Supplemental Application (PANGEA PHARMACEUTICALS, LLC)

  The FDA approved a supplemental application for BUCAPSOL (buspirone hydrochloride) from PANGEA PHARMACEUTICALS, LLC, under an ANDA supplemen…

• FDA approval · 2025-10-09
  FDA Approved: ESCITALOPRAM — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for Escitalopram oxalate (escitalopram) from Sun Pharmaceutical Industries, authorizing its marketin…

• FDA approval · 2025-10-06
  FDA Approved: BUSPIRONE HYDROCHLORIDE — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for buspirone hydrochloride from Rising Pharma Holdings, Inc., allowing a change to an existing gene…

• FDA approval · 2025-10-01
  FDA Approved: PREGABALIN — Supplemental Application (Creekwood Pharmaceuticals LLC)

  The FDA approved a supplemental application for pregabalin from Creekwood Pharmaceuticals LLC under ANDA213423.

• FDA approval · 2025-09-24
  FDA Approved: PAROXETINE — Original Application (Alembic Pharmaceuticals Inc.)

  FDA approves Alembic Pharmaceuticals Inc. Paroxetine Original Application for a generic paroxetine product.

• FDA approval · 2025-09-17
  FDA Approved: VENLAFAXINE HYDROCHLORIDE — Supplemental Application (Epic Pharma, LLC)

  The FDA approved a supplemental application for venlafaxine hydrochloride from Epic Pharma, LLC under an ANDA.

• FDA approval · 2025-09-17
  FDA Approved: PREGABALIN — Supplemental Application (MARKSANS PHARMA LIMITED)

  The FDA approved a supplemental application for pregabalin from Marksans Pharma Limited, resulting in approval of a generic pregabalin produ…

• FDA approval · 2025-09-02
  FDA Approved: VENLAFAXINE HYDROCHLORIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved Sun Pharmaceutical Industries, Inc.'s supplemental application for a generic venlafaxine hydrochloride product.

• FDA approval · 2025-08-29
  FDA Approved: ESCITALOPRAM — Original Application (Almatica Pharma LLC)

  FDA approved the original application for escitalopram from Almatica Pharma LLC, making a generic escitalopram available. The approval cover…

• FDA approval · 2025-08-21
  FDA Approved: PREGABALIN — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' supplemental ANDA for pregabalin, authorizing the marketing of a generic pregabalin product.

• FDA approval · 2025-08-21
  FDA Approved: PREGABALIN — Supplemental Application (ScieGen Pharmaceuticals, Inc)

  FDA approved a supplemental application for pregabalin from ScieGen Pharmaceuticals, Inc., confirming approval of the generic product under …

• FDA approval · 2025-08-18
  FDA Approved: PREGABALIN — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for Pregabalin submitted by Rising Pharma Holdings, Inc. under the approved ANDA.

• FDA approval · 2025-08-15
  FDA Approved: PREGABALIN — Supplemental Application (Indoco Remedies Limited)

  FDA approved a supplemental application for pregabalin from Indoco Remedies Limited, resulting in approval of a generic pregabalin product.

• FDA approval · 2025-07-21
  FDA Approved: PREGABALIN — Supplemental Application (Alembic Pharmaceuticals Inc.)

  FDA approved Alembic Pharmaceuticals' supplemental application for pregabalin. The approval enables the marketing of a generic pregabalin pr…

• FDA approval · 2025-07-21
  FDA Approved: PREGABLIN — Supplemental Application (Macleods Pharmaceuticals Limited)

  FDA approved a supplemental application for pregabalin from Macleods Pharmaceuticals Limited, authorizing a generic version of the drug. Thi…

• FDA approval · 2025-07-15
  FDA Approved: ESCITALOPRAM OXALATE — Original Application (Ascent Pharmaceuticals, Inc)

  FDA approved escitalopram oxalate as a generic product for Ascent Pharmaceuticals, Inc (ANDA 215177). It is intended to be used for the same…

• FDA approval · 2025-07-07
  FDA Approved: PREGABALIN — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approves a supplemental application for Pregabalin from Torrent Pharmaceuticals Limited, enabling the generic drug to be marketed.

• FDA approval · 2025-07-07
  FDA Approved: PREGABALIN — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  The FDA approved a supplemental application for pregabalin filed by Amneal Pharmaceuticals NY LLC.

• FDA approval · 2025-07-03
  FDA Approved: BUSPIRONE HYDROCHLORIDE — Supplemental Application (Radha Pharmaceuticals, Inc.)

  FDA approved a supplemental application for buspirone hydrochloride from Radha Pharmaceuticals, Inc. The approval confirms the generic produ…