Insomnia

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

  The FDA approved Ascend Laboratories, LLC's supplemental application for Temazepam (generic) under the ANDA pathway.

• FDA approval · 2012-03-05
  FDA Approved: IBUPROFEN PM — Original Application (TOP CARE (Topco Associates LLC))

  FDA approved Ibuprofen PM from Top Care (Topco Associates LLC) as an original ANDA, a nighttime analgesic combining ibuprofen with diphenhyd…

• FDA approval · 2012-03-01
  FDA Approved: ROZEREM — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  The FDA approved a supplemental application for ROZEREM (ramelteon) submitted by Takeda Pharmaceuticals America, Inc. The notice confirms th…

• FDA approval · 2012-02-21
  FDA Approved: ROZEREM — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved a supplemental application for ROZEREM (ramelteon) submitted by Takeda Pharmaceuticals America, Inc.

• FDA approval · 2012-01-26
  FDA Approved: LUNESTA — Supplemental Application (Waylis Therapeutics LLC)

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

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• FDA approval · 2011-10-30
  FDA Approved: SILENOR — Supplemental Application (Currax Pharmaceuticals LLC)

  FDA approved a supplemental NDA for Silenor (doxepin hydrochloride) by Currax Pharmaceuticals LLC. The approval relates to a change to the p…

• FDA approval · 2011-09-13
  FDA Approved: ESZOPICLONE — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approved the original application for Eszopiclone (generic) by Lupin Pharmaceuticals, establishing a generic formulation for insomnia tr…

• FDA approval · 2011-08-10
  FDA Approved: EDLUAR — Supplemental Application (Viatris Specialty LLC)

  The FDA approved a supplemental application for EDLUAR (zolpidem tartrate) submitted by Viatris Specialty LLC.

• FDA approval · 2011-08-04
  FDA Approved: ROZEREM — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  The FDA approved a supplemental application for Rozerem (ramelteon) from Takeda Pharmaceuticals America, Inc.

• FDA approval · 2011-07-01
  FDA Approved: ZOLPIDEM TARTRATE — Original Application (Sandoz Inc)

  FDA approves Sandoz Inc's original ANDA for zolpidem tartrate, a generic product for the short-term treatment of insomnia.

• FDA approval · 2011-05-23
  FDA Approved: ESZOPICLONE — Original Application (Teva Pharmaceuticals USA, Inc.)

  Eszopiclone received FDA approval via its original application for the treatment of insomnia.

• FDA approval · 2011-05-09
  FDA Approved: ZOLPIDEM TARTRATE — Supplemental Application (NorthStar Rx LLC)

  The FDA approved a supplemental application for zolpidem tartrate filed by NorthStar Rx LLC.

• FDA approval · 2010-12-17
  FDA Approved: EDLUAR — Supplemental Application (Viatris Specialty LLC)

  The FDA approved a supplemental NDA for EDLUAR (zolpidem tartrate) filed by Viatris Specialty LLC. The approval reflects changes approved as…

• FDA approval · 2010-12-08
  FDA Approved: ZOLPIDEM TARTRATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for zolpidem tartrate submitted by Teva Pharmaceuticals USA, Inc.

• FDA approval · 2010-11-30
  FDA Approved: ZOLPIDEM TARTRATE — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for zolpidem tartrate submitted by Sandoz Inc., resulting in changes to the labeling of this gen…

• FDA approval · 2010-11-22
  FDA Approved: IBUPROFEN, DIPHENHYDRAMINE HCL — Original Application (Bionpharma Inc.)

  FDA approved the original application for a combination product of ibuprofen and diphenhydramine HCl by Bionpharma Inc., intended for tempor…

• FDA approval · 2010-09-01
  FDA Approved: ADVIL PM- DIPHENHYDRAMINE CITRATE AND IBUPROFEN TABLET, COATED — Supplemental Application (Lil Drug Store Products, Inc)

  The FDA approved a supplemental application for Advil PM, a coated tablet containing diphenhydramine citrate and ibuprofen. The sponsor is L…

• FDA approval · 2010-08-16
  FDA Approved: ZOLPIDEM — Supplemental Application (ACI Healthcare USA, Inc)

  The FDA approved a supplemental application for zolpidem tartrate from ACI Healthcare USA, Inc., approving changes to its approved generic p…

• FDA approval · 2010-08-16
  FDA Approved: ZOLPIDEM TARTRATE — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved a supplemental application for Zolpidem Tartrate from Torrent Pharmaceuticals Limited.

• FDA approval · 2010-04-14
  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 · 2010-04-14
  FDA Approved: ZOLPIDEM TARTRATE — Supplemental Application (Sanofi-Aventis U.S. LLC)

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

• FDA approval · 2010-03-17
  FDA Approved: SILENOR — Original Application (Currax Pharmaceuticals LLC)

  The FDA approved Silenor (doxepin hydrochloride) through an original NDA by Currax Pharmaceuticals LLC for the treatment of insomnia in adul…

• FDA approval · 2010-01-08
  FDA Approved: ZOLPIDEM TARTRATE — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved a supplemental application for zolpidem tartrate from Torrent Pharmaceuticals Limited, authorizing continued marketing of a gen…

• FDA approval · 2009-09-17
  FDA Approved: ZALEPLON — Original Application (Bionpharma Inc.)

  FDA approved the original application for Zaleplon from Bionpharma Inc., enabling the generic version of Zaleplon to be marketed for insomni…

• FDA approval · 2009-06-10
  FDA Approved: DIPHENHYDRAMINE HYDROCHLORIDE — Supplemental Application (PAI Holdings, LLC dba PAI Pharma)

  FDA approved a supplemental application for diphenhydramine hydrochloride (PAI Pharma) under an ANDA.