Postherpetic Neuralgia

• 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 (Exelan Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Gabapentin from Exelan Pharmaceuticals, Inc. (ANDA 090705).

• 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 · 2011-07-21
  FDA Approved: GABAPENTIN — Original Application (TIME CAP LABORATORIES, INC)

  FDA approved gabapentin as a generic drug under an Original Application submitted by Time Cap Laboratories, Inc. This approval enables marke…

• FDA approval · 2011-07-14
  FDA Approved: GABAPENTIN — Supplemental Application (Ascend Laboratories, LLC)

  FDA approved a supplemental application for gabapentin submitted by Ascend Laboratories, LLC.

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• FDA approval · 2011-06-28
  FDA Approved: GRALISE — Supplemental Application (Almatica Pharma LLC)

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

• FDA approval · 2011-06-20
  FDA Approved: LYRICA — Supplemental Application (Parke-Davis Div of Pfizer Inc)

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

• FDA approval · 2011-04-26
  FDA Approved: LYRICA — Supplemental Application (Parke-Davis Div of Pfizer Inc)

  FDA approved a supplemental application for LYRICA (pregabalin) filed by Parke-Davis Div of Pfizer Inc.

• FDA approval · 2011-04-26
  FDA Approved: PREGABALIN — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for pregabalin submitted by Mylan Pharmaceuticals Inc., updating the regulatory status of the produc…

• FDA approval · 2011-04-06
  FDA Approved: HORIZANT — Original Application (Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals))

  FDA approved Horizant (gabapentin enacarbil) under an original application for the treatment of restless legs syndrome in adults and posther…

• 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 · 2011-03-01
  FDA Approved: NEURONTIN — Supplemental Application (Parke-Davis Div of Pfizer Inc)

  The FDA approved a supplemental application for Neurontin (gabapentin) from the Parke-Davis Division of Pfizer Inc, resulting in an updated …

• FDA approval · 2011-02-18
  FDA Approved: GABAPENTIN — Original Application (BioComp Pharma, Inc.)

  FDA approved BioComp Pharma, Inc.'s original application for gabapentin, granting generic status and permission to market the product. Gabap…

• FDA approval · 2011-02-11
  FDA Approved: GABAPENTIN — Original Application (Zydus Pharmaceuticals USA Inc.)

  FDA approves Zydus Pharmaceuticals USA Inc.'s Gabapentin under an original ANDA, authorizing a generic gabapentin product.

• FDA approval · 2011-01-28
  FDA Approved: GRALISE — Original Application (Almatica Pharma LLC)

  FDA granted approval for GRALISE (gabapentin) under the original NDA from Almatica Pharma LLC for the treatment of postherpetic neuralgia.

• 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 · 2010-12-17
  FDA Approved: GABAPENTIN — Original Application (Ascend Laboratories, LLC)

  FDA approved Ascend Laboratories, LLC's Original Application for gabapentin (generic), authorizing its use for partial seizures in epilepsy …

• FDA approval · 2010-05-17
  FDA Approved: GABAPENTIN — Supplemental Application (Amneal Pharmaceuticals LLC)

  The FDA approved a supplemental application for gabapentin filed by Amneal 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.

• FDA approval · 2010-05-13
  FDA Approved: GABAPENTIN — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for gabapentin from Actavis Pharma, Inc. under ANDA075350, typically reflecting a label change or fo…

• FDA approval · 2010-05-13
  FDA Approved: GABAPENTIN — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA granted supplemental approval for gabapentin submitted by Sun Pharmaceutical Industries, Inc.

• FDA approval · 2010-04-13
  FDA Approved: LIDOCAINE — Supplemental Application (Endo USA, Inc.)

  The FDA approved a supplemental application for Lidocaine Patch 5% from Endo USA, Inc., expanding the regulatory authorization for this prod…

• FDA approval · 2010-01-04
  FDA Approved: PREGABALIN — Original Application (Mylan Pharmaceuticals Inc.)

  FDA approved the original application for pregabalin from Mylan Pharmaceuticals, confirming a generic version of the drug.

• FDA approval · 2009-12-30
  FDA Approved: GABAPENTIN — Original Application (Exelan Pharmaceuticals, Inc.)

  The FDA approves Exelan Pharmaceuticals, Inc.'s original application for gabapentin as a generic product.