Neuropathic Pain

• FDA approval · 2021-02-19
  FDA Approved: AMITRIPTYLINE HYDROCHLORIDE — Original Application (Lifestar Pharma LLC)

  FDA-approved Amitriptyline hydrochloride as a generic product via Original Application by Lifestar Pharma LLC.

• FDA approval · 2020-12-16
  FDA Approved: NEURONTIN — Supplemental Application (Parke-Davis Div of Pfizer Inc)

  The FDA approved a supplemental application for Neurontin (gabapentin) submitted by Parke-Davis Division of Pfizer Inc, indicating a change …

• FDA approval · 2020-09-29
  FDA Approved: GABAPENTIN — Supplemental Application (ScieGen Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Gabapentin from ScieGen Pharmaceuticals, Inc.

• FDA approval · 2020-03-23
  FDA Approved: PREGABALIN — Original Application (Creekwood Pharmaceuticals LLC)

  FDA approves Creekwood Pharmaceuticals LLC's Original Application (ANDA) for pregabalin, enabling a generic version of the drug. This action…

• FDA approval · 2017-12-27
  FDA Approved: GABAPENTIN — Supplemental Application (Creekwood Pharmaceuticals LLC)

  The FDA approved a supplemental application for gabapentin submitted by Creekwood Pharmaceuticals LLC. The approval covers changes to an alr…

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• 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 · 2016-09-30
  FDA Approved: TAPENTADOL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Tapentadol hydrochloride submitted by Hikma Pharmaceuticals USA Inc.

• FDA approval · 2015-09-17
  FDA Approved: GABAPENTIN — Supplemental Application (Advagen Pharma Ltd)

  FDA approved a supplemental application for gabapentin filed by Advagen Pharma Ltd. The approval updates the approved generic product as par…

• FDA approval · 2015-09-10
  FDA Approved: GABAPENTIN — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for gabapentin filed by Sun Pharmaceutical Industries, Inc. The approval reflects a supplemental cha…

• FDA approval · 2015-07-15
  FDA Approved: NORTRIPTYLINE HYDROCHLORIDE — Supplemental Application (Dr. Reddy's Laboratories Inc.)

  The FDA approved a supplemental application for Nortriptyline Hydrochloride from Dr. Reddy's Laboratories Inc.

• FDA approval · 2015-04-21
  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 · 2015-03-05
  FDA Approved: GABAPENTIN — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Gabapentin from Aurobindo Pharma Limited, enabling the generic product's continued marketing und…

• FDA approval · 2014-11-08
  FDA Approved: GABAPENTIN — Supplemental Application (Amneal Pharmaceuticals LLC)

  The FDA approved Amneal Pharmaceuticals LLC's supplemental application for gabapentin (generic anticonvulsant) under the approved ANDA.

• FDA approval · 2013-02-28
  FDA Approved: PREGABALIN — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for pregabalin from Mylan Pharmaceuticals Inc. The approval confirms regulatory status of the generi…

• FDA approval · 2012-04-11
  FDA Approved: GABAPENTIN — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for gabapentin submitted by Zydus Pharmaceuticals USA Inc. under ANDA 078926.

• FDA approval · 2012-03-23
  FDA Approved: GABAPENTIN — Original Application (Amneal Pharmaceuticals LLC)

  The FDA approved Amneal Pharmaceuticals' original Abbreviated New Drug Application for gabapentin, authorizing a generic gabapentin product.

• FDA approval · 2011-11-25
  FDA Approved: GABAPENTIN — Supplemental Application (BluePoint Laboratories)

  The FDA approved a supplemental application for gabapentin submitted by BluePoint Laboratories.

• FDA approval · 2011-08-30
  FDA Approved: GABAPENTIN — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for gabapentin submitted by Zydus Pharmaceuticals USA Inc.

• FDA approval · 2011-08-30
  FDA Approved: GABAPENTIN — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for Gabapentin from Aurobindo Pharma Limited under an approved ANDA.

• FDA approval · 2011-08-29
  FDA Approved: GABAPENTIN — Supplemental Application (BluePoint Laboratories)

  FDA approves a supplemental application for Gabapentin from BluePoint Laboratories, updating the existing approval for the generic product.

• FDA approval · 2011-03-30
  FDA Approved: GABAPENTIN — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for gabapentin from Sun Pharmaceutical Industries, Inc. (ANDA077242), confirming regulatory approval…

• FDA approval · 2011-03-30
  FDA Approved: GABAPENTIN — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application for gabapentin from Amneal Pharmaceuticals LLC. This entry reflects a supplemental approval of a gen…

• FDA approval · 2011-01-10
  FDA Approved: GABAPENTIN — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for gabapentin from Aurobindo Pharma Limited, marking a supplemental approval for this generic g…

• FDA approval · 2010-10-24
  FDA Approved: EQUETRO — Supplemental Application (Validus Pharmaceuticals LLC)

  FDA approved a supplemental application for EQUETRO (carbamazepine) from Validus Pharmaceuticals LLC.

• FDA approval · 2010-05-14
  FDA Approved: GABAPENTIN — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for Gabapentin from Sun Pharmaceutical Industries, Inc.