Insomnia

• FDA approval · 2021-06-11
  FDA Approved: TEMAZEPAM — Supplemental Application (Alembic Pharmaceuticals Limited)

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

• FDA approval · 2021-03-25
  FDA Approved: BELSOMRA — Supplemental Application (Merck Sharp & Dohme LLC)

  FDA approved a supplemental application for BELSOMRA (suvorexant) from Merck Sharp & Dohme LLC, updating the product labeling.

• FDA approval · 2021-03-09
  FDA Approved: DOXEPIN HYDROCHLORIDE — Original Application (Leading Pharma, LLC)

  FDA approved the original application for doxepin hydrochloride (generic) from Leading Pharma, LLC, for use in treating depressive disorders…

• FDA approval · 2021-02-08
  FDA Approved: FLURAZEPAM HYDROCHLORIDE — Supplemental Application (Chartwell RX, LLC)

  The FDA approved a supplemental application for Flurazepam hydrochloride (generic) filed by Chartwell RX, LLC.

• FDA approval · 2021-02-08
  FDA Approved: FLURAZEPAM HYDROCHLORIDE — Supplemental Application (Chartwell RX, LLC)

  The FDA approved a supplemental application for Flurazepam Hydrochloride filed by Chartwell RX, LLC. This action authorizes a modification t…

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• FDA approval · 2021-02-05
  FDA Approved: ESTAZOLAM — Supplemental Application (Novitium Pharma LLC)

  FDA approves a supplemental application for Estazolam by Novitium Pharma LLC under ANDA074826.

• FDA approval · 2021-02-05
  FDA Approved: ESTAZOLAM — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for ESTAZOLAM from Actavis Pharma, Inc. for a revised/expanded labeling and/or indication of this ge…

• FDA approval · 2021-02-05
  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 · 2021-02-05
  FDA Approved: RESTORIL — Supplemental Application (SpecGx LLC)

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

• FDA approval · 2021-02-05
  FDA Approved: ESTAZOLAM — Supplemental Application (Dr. Reddy's Labratories Inc.)

  The FDA approved a supplemental application for Estazolam (ESTAZOLAM) from Dr. Reddy's Laboratories Inc.

• FDA approval · 2020-10-29
  FDA Approved: SILENOR — Supplemental Application (Currax Pharmaceuticals LLC)

  FDA approved a supplemental application for SILENOR (doxepin hydrochloride) submitted by Currax Pharmaceuticals LLC.

• FDA approval · 2020-10-26
  FDA Approved: RAMELTEON — Original Application (Upsher-Smith Laboratories, LLC)

  FDA approved an original ANDA for ramelteon from Upsher-Smith Laboratories, enabling a generic ramelteon product to reach the market. Ramelt…

• FDA approval · 2020-10-20
  FDA Approved: TRIAZOLAM — Original Application (Ingenus Pharmaceuticals, LLC)

  FDA approved a generic version of triazolam (Ingenus Pharmaceuticals, LLC) under ANDA 214219.

• FDA approval · 2020-08-25
  FDA Approved: DAYVIGO — Supplemental Application (Eisai Inc.)

  The FDA approved a supplemental application for DAYVIGO (lemorexant) submitted by Eisai Inc.

• FDA approval · 2020-08-21
  FDA Approved: RAMELTEON — Original Application (Granules Pharmaceuticals Inc.)

  The FDA approved a generic ramelteon product from Granules Pharmaceuticals Inc. for treatment of insomnia, expanding access to this sleep-on…

• FDA approval · 2020-07-28
  FDA Approved: DOXEPIN HYDROCHLORIDE — Original Application (Contract Pharmacal Corp.)

  FDA approved an original application for doxepin hydrochloride, a generic product from Contract Pharmacal Corp., with labeling for major dep…

• FDA approval · 2020-07-24
  FDA Approved: DOXEPIN — Original Application (Strides Pharma Science Limited)

  FDA approved an original application for doxepin hydrochloride (generic doxepin) by Strides Pharma Science Limited, expanding the availabili…

• FDA approval · 2020-07-02
  FDA Approved: ZOLPIDEM TARTRATE SUBLINGUAL — Supplemental Application (ENDO USA, Inc.)

  FDA approved a supplemental application to allow the marketing of zolpidem tartrate sublingual, a sublingual formulation of zolpidem, develo…

• FDA approval · 2020-06-04
  FDA Approved: ZOLPIDEM TARTRATE — Original Application (Breckenridge Pharmaceutical, Inc.)

  FDA approves Breckenridge Pharmaceutical's original ANDA for zolpidem tartrate, a generic sleep-aid formulation for insomnia.

• FDA approval · 2020-04-27
  FDA Approved: ESZOPICLONE — Supplemental Application (Bionpharma Inc.)

  The FDA approved a supplemental application for eszopiclone, enabling the approval of a generic version manufactured by Bionpharma Inc. for …

• FDA approval · 2020-04-10
  FDA Approved: RAMELTEON — Original Application (TruPharma, LLC)

  FDA approved the original ANDA for ramelteon filed by TruPharma, LLC, establishing a generic ramelteon product.

• FDA approval · 2020-04-06
  FDA Approved: ALEVE PM — Supplemental Application (Bayer HealthCare LLC.)

  FDA approved a supplemental application for Aleve PM, adding the diphenhydramine HCl and naproxen sodium combination (Bayer HealthCare LLC) …

• FDA approval · 2020-03-18
  FDA Approved: BELSOMRA — Supplemental Application (Merck Sharp & Dohme LLC)

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

• FDA approval · 2020-03-17
  FDA Approved: DIPHENHYDRAMINE HYDROCHLORIDE — Supplemental Application (PAI Holdings, LLC dba PAI Pharma)

  FDA approved a supplemental application for Diphenhydramine hydrochloride from PAI Pharma, indicating an approved modification to an existin…

• FDA approval · 2020-02-07
  FDA Approved: RAMELTEON — Supplemental Application (Dr.Reddys Laboratories Inc)

  The FDA entry documents a supplemental application submission for ramelteon from Dr. Reddy's Laboratories as part of an approval action for …