Neuropathic Pain

• FDA approval · 2026-02-17
  FDA Approved: GABAPENTIN — Supplemental Application (Creekwood Pharmaceuticals LLC)

  The FDA approved a supplemental application for gabapentin filed by Creekwood Pharmaceuticals LLC.

• FDA approval · 2026-02-12
  FDA Approved: GABAPENTIN — Supplemental Application (Ascend Laboratories, LLC)

  FDA approved a supplemental application for gabapentin by Ascend Laboratories, LLC, updating regulatory approval for this generic product.

• FDA approval · 2026-01-29
  FDA Approved: GABAPENTIN — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for Gabapentin from Rising Pharma Holdings, Inc.

• FDA approval · 2025-08-26
  FDA Approved: GABAPENTIN — Supplemental Application (Granules Pharmaceuticals Inc)

  The FDA approved a supplemental application for Gabapentin from Granules Pharmaceuticals Inc. This approval updates the product's labeling/i…

• FDA approval · 2025-08-07
  FDA Approved: GABAPENTIN — Original Application (STALLION LABORATORIES PRIVATE LIMITED)

  The FDA approved Stallion Laboratories Private Limited's Original Application for gabapentin, granting approval of a generic gabapentin prod…

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• FDA approval · 2025-06-24
  FDA Approved: AMITRIPTYLINE HYDROCHLORIDE — Supplemental Application (Advagen Pharma Ltd)

  The FDA approved a supplemental application for amitriptyline hydrochloride by Advagen Pharma Ltd, indicating an approved change to an alrea…

• FDA approval · 2025-06-24
  FDA Approved: AMITRIPTYLINE HYDROCHLORIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Amitriptyline Hydrochloride from Aurobindo Pharma Limited, authorizing a generic product's appro…

• FDA approval · 2024-12-27
  FDA Approved: GABAPENTIN — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for gabapentin from Rising Pharma Holdings, Inc. The snippet does not specify the exact scope (e.g.,…

• FDA approval · 2024-12-02
  FDA Approved: GABAPENTIN — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for gabapentin from Sun Pharmaceutical Industries, Inc., authorizing a modification to the approved …

• FDA approval · 2024-09-09
  FDA Approved: GABAPENTIN — Supplemental Application (Rising Pharma Holdings, Inc.)

  The FDA approved a supplemental application for gabapentin from Rising Pharma Holdings, Inc. The approval indicates a modification to the dr…

• FDA approval · 2024-08-28
  FDA Approved: PREGABALIN — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' supplemental application for pregabalin.

• FDA approval · 2024-07-12
  FDA Approved: NEURONTIN — Supplemental Application (Parke-Davis Div of Pfizer Inc)

  FDA approved a supplemental application for Neurontin (gabapentin) submitted by Parke-Davis Div of Pfizer Inc.

• FDA approval · 2024-07-11
  FDA Approved: PREGABALIN — Supplemental Application (ScieGen Pharmaceuticals, Inc)

  FDA approved ScieGen Pharmaceuticals' generic pregabalin product through an abbreviated new drug application.

• FDA approval · 2024-06-24
  FDA Approved: AMITRIPTYLINE HYDROCHLORIDE — Supplemental Application (Lifestar Pharma LLC)

  FDA approved a supplemental application for Amitriptyline Hydrochloride by Lifestar Pharma LLC. The submission status is AP.

• FDA approval · 2024-05-29
  FDA Approved: GABAPENTIN — Supplemental Application (Amneal Pharmaceuticals LLC)

  The FDA approved a supplemental application for Gabapentin submitted by Amneal Pharmaceuticals LLC under ANDA202024.

• FDA approval · 2024-02-26
  FDA Approved: GABAPENTIN — Original Application (Epic Pharma, LLC)

  FDA approved the original application for gabapentin from Epic Pharma, LLC, introducing a generic gabapentin product to the market.

• FDA approval · 2024-01-17
  FDA Approved: GABAPENTIN — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' original application for gabapentin, a generic version of the anticonvulsant used for partial seizures …

• FDA approval · 2023-08-07
  FDA Approved: GABAPENTIN — Supplemental Application (Ajenat Pharmaceuticals LLC)

  FDA approves a supplemental application for Gabapentin submitted by Ajenat Pharmaceuticals LLC.

• FDA approval · 2023-08-02
  FDA Approved: GABAPENTIN — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approves a supplemental application for Gabapentin submitted by Amneal Pharmaceuticals LLC.

• FDA approval · 2023-05-01
  FDA Approved: AMITRIPTYLINE HYDROCHLORIDE — Original Application (Advagen Pharma Ltd)

  FDA approved Advagen Pharma Ltd's original application for Amitriptyline Hydrochloride (generic) under ANDA, authorizing its marketing in th…

• FDA approval · 2023-03-24
  FDA Approved: PREGABALIN — Supplemental Application (Solco Healthcare US, LLC)

  FDA approved a supplemental application for pregabalin from Solco Healthcare US, LLC under ANDA207883. The drug is indicated for neuropathic…

• FDA approval · 2021-10-15
  FDA Approved: GABAPENTIN — Supplemental Application (QUALLENT PHARMACEUTICALS HEALTH LLC)

  FDA approved a supplemental application for gabapentin from Quallent Pharmaceuticals Health LLC, resulting in the approval of their generic …

• FDA approval · 2021-10-01
  FDA Approved: GABAPENTIN — Original Application (XLCare Pharmaceuticals, Inc.)

  FDA approved the original ANDA for gabapentin from XLCare Pharmaceuticals, enabling a generic version of the anticonvulsant.

• FDA approval · 2021-09-29
  FDA Approved: AMITRIPTYLINE HYDROCHLORIDE — Supplemental Application (AiPing Pharmaceutical, Inc.)

  FDA approved a supplemental application for Amitriptyline Hydrochloride, a generic product submitted by AiPing Pharmaceutical, Inc., under t…

• FDA approval · 2021-05-19
  FDA Approved: AMITRIPTYLINE HYDROCHLORIDE — Original Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved Amitriptyline hydrochloride as an original-application generic from Unichem Pharmaceuticals (USA), Inc. (ANDA 214548).