Insomnia

• FDA approval · 2022-11-21
  FDA Approved: ZOLPIDEM TARTRATE — Supplemental Application (Breckenridge Pharmaceutical, Inc.)

  The FDA approved Breckenridge Pharmaceutical, Inc.'s supplemental application for zolpidem tartrate.

• FDA approval · 2022-11-09
  FDA Approved: TRAZODONE HYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for trazodone hydrochloride by Teva Pharmaceuticals USA, Inc., authorizing changes to the produc…

• FDA approval · 2022-11-08
  FDA Approved: QUVIVIQ — Supplemental Application (Idorsia Pharmaceuticals Ltd)

  FDA approved a supplemental application for QUVIVIQ (daridorexant) from Idorsia Pharmaceuticals Ltd, updating the product labeling for the t…

• FDA approval · 2022-09-28
  FDA Approved: ZOLPIDEM TARTRATE — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for zolpidem tartrate from Sandoz Inc, enabling an updated/expanded approval for the generic pro…

• FDA approval · 2022-09-12
  FDA Approved: ZOLPIDEM TARTRATE — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved a supplemental application for zolpidem tartrate submitted by Torrent Pharmaceuticals Limited. This action supports the continu…

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• FDA approval · 2022-09-02
  FDA Approved: ZOLPIDEM TARTRATE — Supplemental Application (NorthStar Rx LLC)

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

• FDA approval · 2022-09-02
  FDA Approved: ZOLPIDEM TARTRATE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved a supplemental application for zolpidem tartrate submitted by Lupin Pharmaceuticals, Inc. under an ANDA.

• FDA approval · 2022-08-09
  FDA Approved: TEMAZEPAM — Supplemental Application (Actavis Pharma, Inc.)

  The FDA approved a supplemental application for Temazepam from Actavis Pharma, Inc., making a generic Temazepam product eligible for marketi…

• FDA approval · 2022-08-03
  FDA Approved: TEMAZEPAM — Supplemental Application (Ascend Laboratories, LLC)

  The FDA approved a supplemental application for Temazepam from Ascend Laboratories, LLC, enabling a generic Temazepam product to be marketed…

• FDA approval · 2022-06-30
  FDA Approved: RAMELTEON — Supplemental Application (Dr.Reddys Laboratories Inc)

  The FDA approved a supplemental application for ramelteon submitted by Dr. Reddy's Laboratories (ANDA 091693) related to the ramelteon produ…

• FDA approval · 2022-06-24
  FDA Approved: DOXEPIN HYDROCHLORIDE — Original Application (Novadoz Pharmaceuticals LLC)

  FDA approved an original application for doxepin hydrochloride as a generic product manufactured by Novadoz Pharmaceuticals LLC.

• FDA approval · 2022-05-31
  FDA Approved: IBUPROFEN PM — Original Application (KROGER COMPANY)

  FDA approved Kroger's Ibuprofen PM, an over-the-counter combination product containing ibuprofen and diphenhydramine citrate, under an origi…

• FDA approval · 2022-05-05
  FDA Approved: RAMELTEON — Supplemental Application (TruPharma, LLC)

  FDA approved a supplemental application for ramelteon submitted by TruPharma, LLC.

• FDA approval · 2022-03-28
  FDA Approved: RAMELTEON — Supplemental Application (Granules Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Granules Pharmaceuticals' generic ramelteon, enabling market entry for the treatment of inso…

• FDA approval · 2022-03-11
  FDA Approved: DAYVIGO — Supplemental Application (Eisai Inc.)

  FDA approved a supplemental application for DAYVIGO (lemborexant) from Eisai Inc.

• FDA approval · 2022-02-23
  FDA Approved: AMBIEN — Supplemental Application (Cosette Pharmaceuticals, Inc.)

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

• FDA approval · 2022-02-23
  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.

• FDA approval · 2022-02-09
  FDA Approved: DOXEPIN HYDROCHLORIDE — Original Application (First Nation Group, LLC)

  FDA approved the original application for a generic doxepin hydrochloride product from First Nation Group, LLC, enabling its marketing in th…

• FDA approval · 2022-01-10
  FDA Approved: ADVIL PM- DIPHENHYDRAMINE CITRATE AND IBUPROFEN TABLET, COATED — Supplemental Application (Lil Drug Store Products, Inc)

  FDA approved a supplemental application for Advil PM, a coated tablet containing ibuprofen and diphenhydramine citrate, with Lil Drug Store …

• FDA approval · 2022-01-07
  FDA Approved: QUVIVIQ — Original Application (Idorsia Pharmaceuticals Ltd)

  FDA approves QUVIVIQ (daridorexant) from Idorsia as an Original Application for treating insomnia in adults.

• FDA approval · 2021-11-12
  FDA Approved: DIAZEPAM — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Diazepam from Hikma Pharmaceuticals USA Inc. under an ANDA, reflecting a regulatory action on th…

• FDA approval · 2021-11-03
  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 · 2021-10-27
  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 · 2021-08-04
  FDA Approved: RAMELTEON — Supplemental Application (Granules Pharmaceuticals Inc.)

  The FDA approved Granules Pharmaceuticals' supplemental application for Ramelteon, adding a granule formulation of ramelteon.

• FDA approval · 2021-08-02
  FDA Approved: ESTAZOLAM — Supplemental Application (Novitium Pharma LLC)

  The FDA approves a supplemental application for Estazolam, with Novitium Pharma LLC as the sponsor, indicating an expansion/approval under a…