Insomnia

• FDA approval · 2008-02-25
  FDA Approved: RESTORIL — Supplemental Application (SpecGx LLC)

  The FDA approved a supplemental application for RESTORIL (temazepam) filed by SpecGx LLC. The action updates the product labeling under the …

• FDA approval · 2008-02-20
  FDA Approved: ESTAZOLAM — Supplemental Application (Dr. Reddy's Labratories Inc.)

  FDA approves a supplemental application for ESTAZOLAM by Dr. Reddy's Laboratories Inc., marking approval of a supplemental submission for th…

• FDA approval · 2008-02-12
  FDA Approved: HALCION — Supplemental Application (Pharmacia & Upjohn Company LLC)

  The FDA approved a supplemental application for HALCION (triazolam) submitted by Pharmacia & Upjohn Company LLC.

• FDA approval · 2008-01-29
  FDA Approved: LUNESTA — Supplemental Application (Waylis Therapeutics LLC)

  The FDA approved a supplemental application for LUNESTA (eszopiclone) filed by Waylis Therapeutics LLC.

• FDA approval · 2007-12-20
  FDA Approved: ZOLPIDEM TARTRATE — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA approved a supplemental application for zolpidem tartrate filed by Sanofi-Aventis U.S. LLC.

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• FDA approval · 2007-12-04
  FDA Approved: ESTAZOLAM — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for Estazolam (Actavis Pharma, Inc.). The drug is used for the short-term treatment of insomnia.

• FDA approval · 2007-10-04
  FDA Approved: AMBIEN — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for AMBIEN (zolpidem tartrate) submitted by Cosette Pharmaceuticals, Inc.

• FDA approval · 2007-09-16
  FDA Approved: ESTAZOLAM — Supplemental Application (Novitium Pharma LLC)

  The FDA approved a supplemental application for Estazolam filed by Novitium Pharma LLC.

• FDA approval · 2007-08-17
  FDA Approved: ZOLPIDEM TARTRATE — Original Application (Torrent Pharmaceuticals Limited)

  FDA approves Torrent Pharmaceuticals Limited's original application for zolpidem tartrate (generic) for the treatment of insomnia.

• FDA approval · 2007-07-11
  FDA Approved: DOXEPIN HYDROCHLORIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental ANDA for doxepin hydrochloride from Mylan Pharmaceuticals Inc., enabling a generic version of the drug to en…

• FDA approval · 2007-06-26
  FDA Approved: DOXEPIN HYDROCHLORIDE — Supplemental Application (Lannett Company, Inc.)

  FDA approved a supplemental application for doxepin hydrochloride from Lannett Company, Inc., authorizing changes to an already approved pro…

• FDA approval · 2007-05-04
  FDA Approved: ZOLPIDEM TARTRATE — Original Application (NorthStar Rx LLC)

  FDA approves NorthStar Rx LLC's Zolpidem tartrate as an Original Application (ANDA) for a generic product to treat insomnia.

• FDA approval · 2007-04-23
  FDA Approved: ZOLPIDEM — Original Application (ACI Healthcare USA, Inc)

  FDA approves the original application for zolpidem tartrate (generic zolpidem) filed by ACI Healthcare USA, Inc., for treatment of insomnia.

• FDA approval · 2007-04-23
  FDA Approved: ZOLPIDEM TARTRATE — Original Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva's original ANDA for zolpidem tartrate, a generic sleep medication for short-term treatment of insomnia.

• FDA approval · 2007-04-23
  FDA Approved: ZOLPIDEM TARTRATE — Original Application (Sandoz Inc)

  FDA approves Sandoz Inc.'s original abbreviated new drug application for zolpidem tartrate, enabling the marketing of a generic zolpidem tar…

• FDA approval · 2007-03-28
  FDA Approved: AMBIEN — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  FDA approved a supplemental application for AMBIEN (zolpidem tartrate) filed by Cosette Pharmaceuticals, Inc., approving an update to the pr…

• FDA approval · 2006-11-29
  FDA Approved: LORAZEPAM — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for Lorazepam by Hikma Pharmaceuticals USA Inc., authorizing modifications under the supplement.

• FDA approval · 2006-05-23
  FDA Approved: LUNESTA — Supplemental Application (Waylis Therapeutics LLC)

  FDA approved a supplemental application for LUNESTA (eszopiclone) submitted by Waylis Therapeutics LLC, updating the labeling to reflect the…