Insomnia

• FDA approval · 2014-04-15
  FDA Approved: ESZOPICLONE — Original Application (Dr. Reddy's Laboratories Limited)

  Generic approval of eszopiclone by Dr. Reddy's Laboratories Limited for treatment of insomnia.

• FDA approval · 2014-04-04
  FDA Approved: LUNESTA — Supplemental Application (Waylis Therapeutics LLC)

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

• FDA approval · 2014-03-12
  FDA Approved: ZALEPLON — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  The FDA approved a supplemental application for Zaleplon from Unichem Pharmaceuticals (USA), Inc., resulting in updated labeling.

• FDA approval · 2014-03-11
  FDA Approved: ZALEPLON — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for Zaleplon from Rising Pharma Holdings, Inc., authorizing the generic zaleplon product.

• FDA approval · 2014-03-11
  FDA Approved: ZALEPLON — Supplemental Application (Bionpharma Inc.)

  The FDA approved a supplemental application for zaleplon filed by Bionpharma Inc., enabling continued marketing of the generic sleep medicat…

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• FDA approval · 2014-02-03
  FDA Approved: LUNESTA — Supplemental Application (Waylis Therapeutics LLC)

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

• FDA approval · 2014-01-21
  FDA Approved: HALCION — Supplemental Application (Pharmacia & Upjohn Company LLC)

  FDA approved a supplemental application for Halcion (triazolam) from Pharmacia & Upjohn Company LLC.

• FDA approval · 2013-09-11
  FDA Approved: ZOLPIDEM TARTRATE — Supplemental Application (NorthStar Rx LLC)

  FDA approved a supplemental application for zolpidem tartrate from NorthStar Rx LLC, enabling the generic drug to be marketed.

• FDA approval · 2013-09-11
  FDA Approved: ZOLPIDEM TARTRATE — Original Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals' generic zolpidem tartrate (ANDA) as an approved product. This generic provides an additional option …

• FDA approval · 2013-09-04
  FDA Approved: ZOLPIDEM TARTRATE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for zolpidem tartrate by Sandoz Inc.

• FDA approval · 2013-09-04
  FDA Approved: ZOLPIDEM TARTRATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for zolpidem tartrate (generic) by Teva Pharmaceuticals USA, Inc.

• FDA approval · 2013-07-26
  FDA Approved: RAMELTEON — Original Application (Dr.Reddys Laboratories Inc)

  FDA approved Dr. Reddy's Ramelteon as an original-application generic (ANDA 091693) for the treatment of insomnia characterized by difficult…

• FDA approval · 2013-06-14
  FDA Approved: ROZEREM — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  The FDA approved a supplemental application for Rozerem (ramelteon) from Takeda Pharmaceuticals America, Inc. The action updates the labelin…

• FDA approval · 2013-06-05
  FDA Approved: AMBIEN — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for AMBIEN (zolpidem tartrate) filed by Cosette Pharmaceuticals, Inc., under NDA 019908.

• FDA approval · 2013-04-19
  FDA Approved: ZOLPIDEM TARTRATE — Supplemental Application (Sanofi-Aventis U.S. LLC)

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

• FDA approval · 2013-04-19
  FDA Approved: EDLUAR — Supplemental Application (Viatris Specialty LLC)

  The FDA approved Viatris Specialty LLC's supplemental application for EDLUAR (zolpidem tartrate), a brand product used to treat insomnia.

• FDA approval · 2013-04-19
  FDA Approved: AMBIEN — Supplemental Application (Cosette Pharmaceuticals, Inc.)

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

• FDA approval · 2013-04-03
  FDA Approved: ESZOPICLONE — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approves Sun Pharmaceutical's original application for eszopiclone, a generic sleep aid used to treat insomnia.

• FDA approval · 2013-03-26
  FDA Approved: ESZOPICLONE — Original Application (Mylan Pharmaceuticals Inc.)

  The FDA approved Mylan's original ANDA for eszopiclone, making a generic version of the sleep medication available for adults with insomnia.

• FDA approval · 2013-01-25
  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 · 2012-10-10
  FDA Approved: LUNESTA — Supplemental Application (Waylis Therapeutics LLC)

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

• FDA approval · 2012-07-30
  FDA Approved: ZOLPIDEM TARTRATE — Original Application (Chartwell RX, LLC)

  The FDA approved Chartwell RX, LLC's original application for zolpidem tartrate, a generic sleep medication for insomnia.

• FDA approval · 2012-06-28
  FDA Approved: PROMETHAZINE HYDROCHLORIDE — Original Application (Cranbury Pharmaceuticals, LLC)

  The FDA approved Promethazine hydrochloride as an original generic drug application (ANDA) for Cranbury Pharmaceuticals, LLC.

• FDA approval · 2012-06-22
  FDA Approved: TEMAZEPAM — Supplemental Application (Ascend Laboratories, LLC)

  FDA approved a supplemental application for Temazepam from Ascend Laboratories, LLC, authorizing a generic Temazepam product.

• FDA approval · 2012-04-17
  FDA Approved: TEMAZEPAM — Supplemental Application (Ascend Laboratories, LLC)

  The FDA granted approval of a supplemental application for Temazepam by Ascend Laboratories, updating an existing Temazepam product.