Postherpetic Neuralgia

• FDA approval · 2020-04-02
  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 · 2020-04-02
  FDA Approved: NEURONTIN — Supplemental Application (Parke-Davis Div of Pfizer Inc)

  The FDA approved a supplemental application for Neurontin (gabapentin) by Parke-Davis Div of Pfizer Inc, authorizing changes to its labeling…

• FDA approval · 2020-03-25
  FDA Approved: GABAPENTIN — Supplemental Application (Ascend Laboratories, LLC)

  FDA approved a supplemental application for gabapentin submitted by Ascend Laboratories, LLC. The approval updates the generic gabapentin pr…

• FDA approval · 2020-03-20
  FDA Approved: PREGABALIN — Original Application (Chartwell RX, LLC)

  FDA approves Chartwell RX, LLC's original ANDA for pregabalin, establishing a generic version of the drug.

• FDA approval · 2019-12-03
  FDA Approved: GABAPENTIN — Original Application (American Health Packaging)

  The FDA approved the original application for gabapentin from American Health Packaging, enabling a generic version of the anticonvulsant.

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• FDA approval · 2019-11-29
  FDA Approved: PREGABALIN — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved the original ANDA for pregabalin from Sun Pharmaceutical Industries, authorizing a generic version of pregabalin.

• FDA approval · 2019-10-08
  FDA Approved: PREGABALIN — Original Application (Camber Pharmaceuticals, Inc.)

  The FDA approved Camber Pharmaceuticals' original Abbreviated New Drug Application for pregabalin, a generic version of the brand product.

• FDA approval · 2019-07-19
  FDA Approved: PREGABALIN — Original Application (Cipla USA, Inc.)

  FDA approves Cipla USA, Inc.'s original application for pregabalin, granting a generic version of the drug for its established indications.

• FDA approval · 2019-07-19
  FDA Approved: PREGABALIN — Original Application (ScieGen Pharmaceuticals, Inc)

  FDA approves ScieGen Pharmaceuticals' original application for pregabalin (generic pregabalin), enabling the generic product to be marketed …

• FDA approval · 2019-07-19
  FDA Approved: PREGABALIN — Original Application (AvPAK)

  FDA approved AvPAK's original application for pregabalin, enabling the generic version to enter the market.

• FDA approval · 2019-07-19
  FDA Approved: PREGABALIN — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved the original application for pregabalin (generic) submitted by Rising Pharma Holdings, Inc., authorizing its market authorizati…

• FDA approval · 2019-07-19
  FDA Approved: PREGABALIN — Original Application (Ascend Laboratories, LLC)

  FDA approved Ascend Laboratories' generic pregabalin under ANDA207623 (original application), providing a generic version of pregabalin.

• FDA approval · 2019-07-19
  FDA Approved: PREGABALIN — Original Application (Alembic Pharmaceuticals Inc.)

  The FDA approved Alembic Pharmaceuticals' original ANDA for pregabalin, enabling a generic version of pregabalin to be marketed. The approva…

• FDA approval · 2019-05-23
  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, indicating an approved modificat…

• FDA approval · 2018-11-02
  FDA Approved: ZTLIDO — Supplemental Application (Scilex Pharmaceuticals Inc.)

  FDA approved a supplemental application for ZTLIDO (lidocaine topical system) by Scilex Pharmaceuticals, updating its labeling.

• FDA approval · 2018-10-16
  FDA Approved: GABAPENTIN — Original Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved the original generic application for gabapentin, enabling a generic version of the anticonvulsant for the same indications as t…

• FDA approval · 2018-05-14
  FDA Approved: GABAPENTIN — Original Application (ACI Healthcare USA, Inc.)

  FDA approved an Original Application (ANDA) for Gabapentin by ACI Healthcare USA, Inc., authorizing a generic gabapentin product.

• FDA approval · 2018-02-28
  FDA Approved: ZTLIDO — Original Application (Scilex Pharmaceuticals Inc.)

  FDA approved ZTLIDO, a lidocaine topical patch, under an original NDA from Scilex Pharmaceuticals. It is indicated for the management of pai…

• 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…

• FDA approval · 2017-10-26
  FDA Approved: GABAPENTIN — Original Application (Precision Dose, Inc.)

  FDA approved the original application for gabapentin from Precision Dose, Inc., establishing a generic version of the anticonvulsant.

• FDA approval · 2017-10-18
  FDA Approved: NEURONTIN — Supplemental Application (Parke-Davis Div of Pfizer Inc)

  The FDA approved a supplemental application for Neurontin (gabapentin) filed by Parke-Davis Div of Pfizer Inc. The approval concerns a modif…

• FDA approval · 2017-10-11
  FDA Approved: LYRICA CR — Original Application (Viatris Specialty LLC)

  FDA approves LYRICA CR (pregabalin) under an Original Application for an extended-release formulation of pregabalin.

• FDA approval · 2017-06-08
  FDA Approved: GABAPENTIN — Supplemental Application (Acella Pharmaceuticals, LLC)

  FDA approved a supplemental application for gabapentin from Acella Pharmaceuticals, LLC.

• FDA approval · 2017-03-24
  FDA Approved: NEURONTIN — Supplemental Application (Parke-Davis Div of Pfizer Inc)

  FDA supplemental approval for Neurontin (gabapentin) by Parke-Davis Division of Pfizer Inc.

• FDA approval · 2017-03-24
  FDA Approved: GABAPENTIN — Original Application (Rising Pharma Holdings, Inc.)

  FDA approves Rising Pharma's original application for gabapentin, a generic version of the anticonvulsant, for the treatment of epilepsy (pa…