Insomnia

• FDA approval · 2023-06-30
  FDA Approved: TEMAZEPAM — Supplemental Application (Alembic Pharmaceuticals Limited)

  FDA approved a supplemental application for Temazepam submitted by Alembic Pharmaceuticals Limited.

• FDA approval · 2023-06-28
  FDA Approved: QUVIVIQ — Supplemental Application (Idorsia Pharmaceuticals Ltd)

  The FDA approved a supplemental application for QUVIVIQ (daridorexant) from Idorsia Pharmaceuticals Ltd.

• FDA approval · 2023-06-27
  FDA Approved: DOXEPIN HYDROCHLORIDE — Original Application (Micro Labs Limited)

  FDA approved the original abbreviated new drug application for doxepin hydrochloride from Micro Labs Limited. Doxepin hydrochloride is used …

• FDA approval · 2023-06-07
  FDA Approved: ESZOPICLONE — Supplemental Application (Macleods Pharmaceuticals Limited)

  FDA approved a supplemental application for Eszopiclone from Macleods Pharmaceuticals Limited.

• FDA approval · 2023-05-09
  FDA Approved: ZOLPIDEM TARTRATE — Original Application (Almatica Pharma LLC)

  FDA approved zolpidem tartrate from Almatica Pharma LLC under an Original Application for the treatment of insomnia.

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• FDA approval · 2023-05-02
  FDA Approved: ESZOPICLONE — Supplemental Application (Macleods Pharmaceuticals Limited)

  FDA approves a supplemental application for Eszopiclone from Macleods Pharmaceuticals Limited, granting approval for the generic product.

• FDA approval · 2023-04-25
  FDA Approved: RAMELTEON — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for ramelteon by Actavis Pharma, Inc. under an ANDA.

• FDA approval · 2023-04-03
  FDA Approved: DOXEPIN HYDROCHLORIDE — Original Application (Novadoz Pharmaceuticals LLC)

  FDA approved Novadoz Pharmaceuticals LLC's original application for doxepin hydrochloride (generic). The approval supports the generic produ…

• FDA approval · 2023-03-24
  FDA Approved: QUVIVIQ — Supplemental Application (Idorsia Pharmaceuticals Ltd)

  The FDA approved a supplemental application for QUVIVIQ (daridorexant) from Idorsia Pharmaceuticals Ltd.

• FDA approval · 2023-03-08
  FDA Approved: ZOLPIDEM TARTRATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for Zolpidem Tartrate (Teva Pharmaceuticals USA, Inc.), the sleep medication previously approved for…

• FDA approval · 2023-02-21
  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 (diphenhydramine citrate and ibuprofen) tablets, coated, expanding its regulatory autho…

• FDA approval · 2023-02-17
  FDA Approved: DOXEPIN HYDROCHLORIDE — Original Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva's generic doxepin hydrochloride for oral use under an Original Application (ANDA).

• FDA approval · 2023-02-09
  FDA Approved: RAMELTEON — Original Application (Micro Labs Limited)

  FDA approved an Abbreviated New Drug Application for ramelteon from Micro Labs Limited, establishing a generic version of the insomnia drug …

• FDA approval · 2023-01-25
  FDA Approved: DAYVIGO — Supplemental Application (Eisai Inc.)

  FDA approves a supplemental application for DAYVIGO (lemorexant) from Eisai Inc., incorporating labeling changes.

• FDA approval · 2023-01-17
  FDA Approved: ESTAZOLAM — Supplemental Application (Novitium Pharma LLC)

  FDA approved a supplemental application for Estazolam from Novitium Pharma LLC.

• FDA approval · 2023-01-17
  FDA Approved: ESTAZOLAM — Supplemental Application (Dr. Reddy's Labratories Inc.)

  FDA approved a supplemental application for Estazolam from Dr. Reddy's Laboratories under ANDA074921, resulting in updated labeling and manu…

• FDA approval · 2023-01-17
  FDA Approved: ESTAZOLAM — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for Estazolam from Actavis Pharma, Inc., updating the regulatory status of this benzodiazepine produ…

• FDA approval · 2023-01-17
  FDA Approved: FLURAZEPAM HYDROCHLORIDE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for flurazepam hydrochloride, with Chartwell RX, LLC listed as the manufacturer. Flurazepam hydrochl…

• FDA approval · 2023-01-17
  FDA Approved: FLURAZEPAM HYDROCHLORIDE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for Flurazepam hydrochloride from Chartwell RX, LLC, indicating continued approval of this generic d…

• FDA approval · 2023-01-13
  FDA Approved: HALCION — Supplemental Application (Pharmacia & Upjohn Company LLC)

  FDA approved a supplemental application for HALCION (triazolam) from Pharmacia & Upjohn Company LLC. The action updates the existing approva…

• FDA approval · 2023-01-13
  FDA Approved: RESTORIL — Supplemental Application (SpecGx LLC)

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

• FDA approval · 2023-01-11
  FDA Approved: TEMAZEPAM — Supplemental Application (Amneal Pharmaceuticals LLC)

  The FDA approved a supplemental application for Temazepam submitted by Amneal Pharmaceuticals LLC.

• FDA approval · 2022-12-28
  FDA Approved: TRIAZOLAM — Original Application (Zydus Pharmaceuticals USA Inc.)

  The FDA approved TRIAZOLAM under an Original Application, authorizing the marketing of a generic triazolam product by Zydus Pharmaceuticals …

• FDA approval · 2022-11-25
  FDA Approved: RAMELTEON — Original Application (Xiromed, LLC)

  FDA approved Xiromed, LLC's ramelteon under an Original Application, providing a generic option for adults with insomnia characterized by di…

• FDA approval · 2022-11-21
  FDA Approved: ZOLPIDEM TARTRATE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for zolpidem tartrate (Sandoz Inc) under ANDA 090107. The snippet does not specify the exact change,…