Insomnia

• FDA label_change · 2023-12-27
  FDA Approved: PROMETHAZINE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Promethazine hydrochloride from Hikma Pharmaceuticals USA, authorizing changes to the product la…

• FDA label_change · 2023-04-20
  FDA Approved: DAYVIGO — Supplemental Application (Eisai Inc.)

  FDA documents a supplemental labeling application for DAYVIGO (lemborexant) by Eisai Inc., likely to modify the drug’s labeling.

• FDA label_change · 2023-03-08
  FDA Approved: ZOLPIDEM TARTRATE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for zolpidem tartrate from Sun Pharmaceutical Industries, Inc., under ANDA 204170.

• FDA label_change · 2022-11-17
  FDA Approved: ZOLPIDEM — Supplemental Application (ACI Healthcare USA, Inc)

  FDA approved a supplemental application for zolpidem tartrate submitted by ACI Healthcare USA, Inc., resulting in updated labeling for the p…

• FDA label_change · 2022-01-11
  FDA Approved: ADVIL PM — Supplemental Application (Haleon US Holdings LLC)

  The FDA approved a supplemental labeling application for Advil PM, a combination product of diphenhydramine HCl and ibuprofen, by Haleon US …

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• FDA label_change · 2021-02-05
  FDA Approved: ATIVAN — Supplemental Application (Bausch Health US LLC)

  The FDA approved a supplemental application for ATIVAN (lorazepam) submitted by Bausch Health US LLC, resulting in a labeling change for the…

• FDA label_change · 2019-10-09
  FDA Approved: HALCION — Supplemental Application (Pharmacia & Upjohn Company LLC)

  FDA approved a supplemental application for HALCION (triazolam) from Pharmacia & Upjohn Company LLC, resulting in changes to the product lab…

• FDA label_change · 2018-09-14
  FDA Approved: ZOLPIDEM TARTRATE — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA approved a supplemental application for zolpidem tartrate by Sanofi-Aventis U.S. LLC to update the labeling of the approved insomnia med…

• FDA label_change · 2016-12-02
  FDA Approved: ZOLPIDEM TARTRATE — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA approved a supplemental application for zolpidem tartrate submitted by Sanofi-Aventis U.S. LLC, resulting in changes to the product labe…

• FDA label_change · 2014-03-11
  FDA Approved: ZALEPLON — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for Zaleplon from Hikma Pharmaceuticals USA Inc., typically affecting the product labeling.

• FDA label_change · 2013-09-18
  FDA Approved: ZOLPIDEM — Supplemental Application (ACI Healthcare USA, Inc)

  The FDA approved a supplemental application for Zolpidem tartrate, indicating changes to the labeling for Zolpidem.

• FDA label_change · 2013-02-04
  FDA Approved: ADVIL PM — Supplemental Application (Haleon US Holdings LLC)

  FDA approved a supplemental application to Advil PM for labeling updates related to the combination of diphenhydramine HCl and ibuprofen (sl…

• FDA label_change · 2010-11-09
  FDA Approved: ROZEREM — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  The FDA approved a supplemental application for ROZEREM (ramelteon) submitted by Takeda Pharmaceuticals America, Inc., resulting in updated …

• FDA label_change · 2010-11-08
  FDA Approved: RESTORIL — Supplemental Application (SpecGx LLC)

  FDA lists a supplemental application for RESTORIL (temazepam) submitted by SpecGx LLC.

• FDA label_change · 2010-03-10
  FDA Approved: ZOLPIDEM TARTRATE — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved a supplemental application for zolpidem tartrate submitted by Torrent Pharmaceuticals Limited. The action involves changes to t…

• FDA label_change · 2009-09-30
  FDA Approved: LUNESTA — Supplemental Application (Waylis Therapeutics LLC)

  FDA approved a supplemental application for Lunesta (eszopiclone) from Waylis Therapeutics LLC, resulting in a label change for the product.

• FDA label_change · 2009-06-02
  FDA Approved: ULTRA SLEEP AID — Supplemental Application (Walgreen Company)

  The FDA approved Walgreens' supplemental application for Ultra Sleep Aid (doxylamine succinate), indicating a labeling change for the produc…

• FDA label_change · 2008-08-05
  FDA Approved: HYDROXYZINE HYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for Hydroxyzine Hydrochloride (Teva Pharmaceuticals USA, Inc.), updating the labeling.