Postherpetic Neuralgia

• FDA approval · 2016-12-22
  FDA Approved: LYRICA — Supplemental Application (Parke-Davis Div of Pfizer Inc)

  The FDA approved a supplemental application for LYRICA (pregabalin) submitted by Parke-Davis Division of Pfizer Inc.

• FDA approval · 2016-11-08
  FDA Approved: GABAPENTIN — Supplemental Application (BluePoint Laboratories)

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

• FDA approval · 2016-11-08
  FDA Approved: GABAPENTIN — Supplemental Application (Amneal Pharmaceuticals LLC)

  The FDA approved Amneal Pharmaceuticals LLC's supplemental application for gabapentin (ANDA078428).

• FDA approval · 2016-03-17
  FDA Approved: LIDOCAINE — Supplemental Application (Endo USA, Inc.)

  FDA approved a supplemental application for lidocaine patch 5% (Lidocaine) by Endo USA, Inc.

• FDA approval · 2016-03-14
  FDA Approved: GABAPENTIN — Original Application (Ajenat Pharmaceuticals LLC)

  FDA approves a new generic gabapentin product (Original Application) by Ajenat Pharmaceuticals LLC under anANDA; the approval covers the sam…

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• FDA approval · 2016-02-24
  FDA Approved: QUTENZA — Supplemental Application (Averitas Pharma Inc)

  FDA approved a supplemental application for QUTENZA (capsaicin) submitted by Averitas Pharma Inc.

• FDA approval · 2016-02-18
  FDA Approved: GABAPENTIN — Original Application (ScieGen Pharmaceuticals, Inc.)

  FDA approved the original generic application for gabapentin from ScieGen Pharmaceuticals, Inc., establishing a generic version of gabapenti…

• FDA approval · 2016-02-04
  FDA Approved: GABAPENTIN — Original Application (Creekwood Pharmaceuticals LLC)

  FDA approved Creekwood Pharmaceuticals LLC's gabapentin under an Abbreviated New Drug Application, authorizing the generic product's market …

• FDA approval · 2016-02-03
  FDA Approved: GABAPENTIN — Supplemental Application (Exelan Pharmaceuticals, Inc.)

  FDA approves a supplemental application for gabapentin from Exelan Pharmaceuticals, Inc., granting regulatory approval for this generic prod…

• FDA approval · 2016-01-13
  FDA Approved: GABAPENTIN — Supplemental Application (Actavis Pharma, Inc.)

  The FDA approved a supplemental application for gabapentin from Actavis Pharma, Inc., updating the approval status for this generic product.

• FDA approval · 2015-12-23
  FDA Approved: GABAPENTIN — Original Application (Ascend Laboratories, LLC)

  FDA approved the gabapentin original application for Ascend Laboratories, LLC, enabling a generic version of gabapentin.

• 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 · 2015-09-17
  FDA Approved: GABAPENTIN — Supplemental Application (Granules Pharmaceuticals Inc)

  The FDA approved a supplemental application for Gabapentin from Granules Pharmaceuticals Inc, authorizing a generic gabapentin product to be…

• 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 · 2015-04-21
  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 · 2015-04-17
  FDA Approved: GABAPENTIN — Supplemental Application (Advagen Pharma Ltd)

  FDA approved a supplemental application for gabapentin submitted by Advagen Pharma Ltd under the existing ANDA. This action updates the regu…

• FDA approval · 2015-04-17
  FDA Approved: GABAPENTIN — Supplemental Application (Granules Pharmaceuticals Inc)

  FDA approved a supplemental application for gabapentin granules from Granules Pharmaceuticals Inc.

• FDA approval · 2015-03-31
  FDA Approved: GABAPENTIN — Supplemental Application (QUALLENT PHARMACEUTICALS HEALTH LLC)

  FDA approved a supplemental application for gabapentin filed by Quallent Pharmaceuticals Health LLC under ANDA200651.

• FDA approval · 2015-03-16
  FDA Approved: GABAPENTIN — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for Gabapentin from Actavis Pharma, Inc., resulting in approval of a generic gabapentin product.

• 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 · 2015-01-07
  FDA Approved: LIDOCAINE — Supplemental Application (Endo USA, Inc.)

  The FDA approved a supplemental application for lidocaine patch 5% (Lidocaine Patch) from Endo USA, Inc., resulting in updated labeling for …

• 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 · 2014-11-08
  FDA Approved: GABAPENTIN — Supplemental Application (Ascend Laboratories, LLC)

  FDA approved a supplemental application for gabapentin submitted by Ascend Laboratories, LLC (ANDA 090858).

• FDA approval · 2014-10-23
  FDA Approved: GABAPENTIN — Supplemental Application (QUALLENT PHARMACEUTICALS HEALTH LLC)

  FDA approved a supplemental application for gabapentin filed by Quallent Pharmaceuticals Health LLC under ANDA200651, enabling marketing of …

• FDA approval · 2014-08-18
  FDA Approved: NEURONTIN — Supplemental Application (Parke-Davis Div of Pfizer Inc)

  FDA approved a supplemental application for Neurontin (gabapentin) by Parke-Davis (Pfizer), resulting in updated labeling.