Postherpetic Neuralgia

• FDA approval · 2014-03-25
  FDA Approved: GABAPENTIN — Supplemental Application (BluePoint Laboratories)

  The FDA approved a supplemental application for gabapentin from BluePoint Laboratories, granting approval of a generic version under ANDA077…

• FDA approval · 2013-10-29
  FDA Approved: HORIZANT — Supplemental Application (Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals))

  The FDA approved a supplemental application for Horizant (gabapentin enacarbil) from Azurity Pharmaceuticals (formerly Arbor Pharmaceuticals…

• FDA approval · 2013-09-09
  FDA Approved: GRALISE — Supplemental Application (Almatica Pharma LLC)

  FDA approved a supplemental application for GRALISE (gabapentin) submitted by Almatica Pharma LLC.

• FDA approval · 2013-07-31
  FDA Approved: GRALISE — Supplemental Application (Almatica Pharma LLC)

  The FDA approved a supplemental application for GRALISE (gabapentin) submitted by Almatica Pharma LLC.

• FDA approval · 2013-07-12
  FDA Approved: GABAPENTIN — Original Application (ACI Healthcare USA, Inc.)

  FDA approved a generic gabapentin product under an Original Application filed by ACI Healthcare USA, Inc.

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• FDA approval · 2013-06-10
  FDA Approved: GRALISE — Supplemental Application (Almatica Pharma LLC)

  FDA approved a supplemental application for GRALISE (gabapentin) from Almatica Pharma LLC.

• FDA approval · 2013-05-01
  FDA Approved: HORIZANT — Supplemental Application (Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals))

  FDA approved a supplemental application for Horizant (gabapentin enacarbil) by Azurity Pharmaceuticals, Inc.

• FDA approval · 2013-04-09
  FDA Approved: GABAPENTIN — Supplemental Application (Advagen Pharma Ltd)

  FDA approved a supplemental application for gabapentin submitted by Advagen Pharma Ltd.

• FDA approval · 2013-04-09
  FDA Approved: GRALISE — Supplemental Application (Almatica Pharma LLC)

  FDA approved a supplemental application for Gralise (gabapentin) submitted by Almatica Pharma LLC. The approved product is used for postherp…

• FDA approval · 2013-03-28
  FDA Approved: GRALISE — Supplemental Application (Almatica Pharma LLC)

  FDA approved a supplemental application for GRALISE (gabapentin) from Almatica Pharma LLC.

• FDA approval · 2013-03-27
  FDA Approved: GRALISE — Supplemental Application (Almatica Pharma LLC)

  The FDA approved a supplemental application for GRALISE (gabapentin) submitted by Almatica Pharma LLC.

• FDA approval · 2013-03-27
  FDA Approved: HORIZANT — Supplemental Application (Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals))

  FDA approved a supplemental application for HORIZANT (gabapentin enacarbil) submitted by Azurity Pharmaceuticals, Inc. (formerly Arbor Pharm…

• FDA approval · 2013-03-25
  FDA Approved: GRALISE — Supplemental Application (Almatica Pharma LLC)

  The FDA approved a supplemental application for GRALISE (gabapentin) submitted by Almatica Pharma LLC.

• FDA approval · 2012-12-26
  FDA Approved: HORIZANT — Supplemental Application (Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals))

  FDA approved a supplemental application for Horizant (gabapentin enacarbil) submitted by Azurity Pharmaceuticals (formerly Arbor Pharmaceuti…

• FDA approval · 2012-08-08
  FDA Approved: GRALISE — Supplemental Application (Almatica Pharma LLC)

  FDA approved a supplemental application for GRALISE (gabapentin) submitted by Almatica Pharma LLC.

• FDA approval · 2012-05-20
  FDA Approved: GABAPENTIN — Supplemental Application (Ascend Laboratories, LLC)

  FDA approved a supplemental application for Gabapentin from Ascend Laboratories, LLC, under an ANDA, indicating approval related to this gen…

• FDA approval · 2012-05-01
  FDA Approved: GABAPENTIN — Original Application (Acella Pharmaceuticals, LLC)

  FDA approves Acella Pharmaceuticals' Gabapentin generic (ANDA 076403). The approval allows the generic product to be marketed for the same i…

• FDA approval · 2012-04-19
  FDA Approved: GABAPENTIN — Supplemental Application (Amneal Pharmaceuticals LLC)

  The FDA approved a supplemental application for gabapentin from Amneal Pharmaceuticals LLC, authorizing changes to the product under an exis…

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

  The FDA approved a supplemental application for gabapentin submitted by Exelan Pharmaceuticals, Inc. This action confirms an approved supple…

• 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 · 2012-01-31
  FDA Approved: GRALISE — Supplemental Application (Almatica Pharma LLC)

  The FDA approved a supplemental application for GRALISE (gabapentin) filed by Almatica Pharma LLC.

• 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 · 2011-09-29
  FDA Approved: GABAPENTIN — Supplemental Application (BluePoint Laboratories)

  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.