Insomnia

• FDA approval · 2020-02-07
  FDA Approved: RAMELTEON — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for ramelteon (Actavis Pharma, Inc.), resulting in an additional regulatory approval for the product…

• FDA approval · 2020-01-29
  FDA Approved: BELSOMRA — Supplemental Application (Merck Sharp & Dohme LLC)

  FDA approved a supplemental application for BELSOMRA (suvorexant) submitted by Merck Sharp & Dohme LLC.

• FDA approval · 2019-12-26
  FDA Approved: DIAZEPAM — Original Application (Natco Pharma USA LLC)

  FDA approved Natco Pharma USA LLC's original application for a generic diazepam product, enabling its marketing in the United States.

• FDA approval · 2019-12-20
  FDA Approved: DAYVIGO — Original Application (Eisai Inc.)

  FDA approved DAYVIGO (lemborexant) from Eisai as the original application for adults with insomnia, marking the drug's initial regulatory au…

• FDA approval · 2019-12-20
  FDA Approved: ESZOPICLONE — Supplemental Application (Dr. Reddy's Laboratories Limited)

  The FDA approved Dr. Reddy's Laboratories Limited's supplemental application for eszopiclone, granting approval of a generic version of the …

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• FDA approval · 2019-12-03
  FDA Approved: ESZOPICLONE — Supplemental Application (Macleods Pharmaceuticals Limited)

  The FDA approved a supplemental application for a generic eszopiclone product from Macleods Pharmaceuticals Limited.

• FDA approval · 2019-11-29
  FDA Approved: ZOLPIDEM TARTRATE — Supplemental Application (Torrent Pharmaceuticals Limited)

  The FDA approved Torrent Pharmaceuticals Limited's supplemental application for zolpidem tartrate (generic). The approval allows the generic…

• FDA approval · 2019-11-29
  FDA Approved: ZOLPIDEM TARTRATE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA granted supplemental approval for zolpidem tartrate submitted by Lupin Pharmaceuticals, Inc. under an ANDA.

• FDA approval · 2019-11-29
  FDA Approved: ZOLPIDEM TARTRATE — Supplemental Application (Lupin Pharmaceuticals,Inc.)

  The FDA approved Lupin Pharmaceuticals' supplemental application for a generic zolpidem tartrate product (ANDA 204299). Zolpidem tartrate is…

• FDA approval · 2019-11-19
  FDA Approved: ZOLPIDEM TARTRATE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for Zolpidem Tartrate submitted by Sandoz Inc.

• FDA approval · 2019-11-19
  FDA Approved: ZOLPIDEM TARTRATE — Supplemental Application (Sandoz Inc)

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

• FDA approval · 2019-11-15
  FDA Approved: ZOLPIDEM TARTRATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

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

• FDA approval · 2019-11-12
  FDA Approved: ESZOPICLONE — Supplemental Application (Glenmark Pharmaceuticals Inc. USA)

  The FDA approved a supplemental application for Eszopiclone submitted by Glenmark Pharmaceuticals Inc. USA.

• FDA approval · 2019-11-07
  FDA Approved: ESZOPICLONE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva Pharmaceuticals' supplemental application for eszopiclone (generic), a sleep medication used to treat insomnia. This actio…

• FDA approval · 2019-11-04
  FDA Approved: ESZOPICLONE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application from Mylan Pharmaceuticals for eszopiclone (generic), under ANDA 091151, to support the marketin…

• FDA approval · 2019-11-04
  FDA Approved: ESZOPICLONE — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for Eszopiclone from Aurobindo Pharma Limited, authorizing a generic version of the prescription…

• FDA approval · 2019-10-25
  FDA Approved: ZOLPIDEM TARTRATE — Supplemental Application (Chartwell RX, LLC)

  The FDA approved a supplemental application for zolpidem tartrate submitted by Chartwell RX, LLC.

• FDA approval · 2019-10-21
  FDA Approved: ZALEPLON — Supplemental Application (Bionpharma Inc.)

  FDA approved a supplemental application for Zaleplon submitted by Bionpharma Inc. The approval confirms continued marketing of the generic d…

• FDA approval · 2019-10-21
  FDA Approved: ZALEPLON — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for the generic sleep aid Zaleplon from Hikma Pharmaceuticals USA Inc., authorizing a modificati…

• FDA approval · 2019-10-17
  FDA Approved: ZALEPLON — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for Zaleplon submitted by Rising Pharma Holdings, Inc.

• FDA approval · 2019-10-03
  FDA Approved: ZALEPLON — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved a supplemental application for Zaleplon from Unichem Pharmaceuticals (USA), Inc., under the existing ANDA.

• FDA approval · 2019-09-30
  FDA Approved: TEMAZEPAM — Supplemental Application (Actavis Pharma, Inc.)

  FDA approves a supplemental application for Temazepam from Actavis Pharma, Inc.

• FDA approval · 2019-09-20
  FDA Approved: TEMAZEPAM — Supplemental Application (Ascend Laboratories, LLC)

  FDA approved a supplemental application for temazepam filed by Ascend Laboratories, LLC.

• FDA approval · 2019-09-19
  FDA Approved: ZOLPIDEM TARTRATE — Supplemental Application (NorthStar Rx LLC)

  FDA approved a supplemental application for zolpidem tartrate from NorthStar Rx LLC, granting approval for the generic insomnia medication. …

• FDA approval · 2019-08-27
  FDA Approved: TEMAZEPAM — Supplemental Application (Ascend Laboratories, LLC)

  FDA approved a supplemental application for Temazepam by Ascend Laboratories, LLC. This action authorizes a supplemental approval to an exis…