Insomnia
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Sign up freeTop drugs studied for this disease
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FDA approval · 2019-08-18FDA Approved: LUNESTA — Supplemental Application (Waylis Therapeutics LLC)
The FDA approved a supplemental application for LUNESTA (eszopiclone) submitted by Waylis Therapeutics LLC.
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FDA approval · 2019-08-18FDA Approved: AMBIEN — Supplemental Application (Cosette Pharmaceuticals, Inc.)
The FDA approved a supplemental application from Cosette Pharmaceuticals, Inc. for Ambien (zolpidem tartrate) under NDA 019908. The action r…
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FDA approval · 2019-08-18FDA 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.
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FDA approval · 2019-08-18FDA Approved: EDLUAR — Supplemental Application (Viatris Specialty LLC)
The FDA approved a supplemental application for EDLUAR (zolpidem tartrate) from Viatris Specialty LLC.
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FDA approval · 2019-07-22FDA Approved: RAMELTEON — Original Application (Zydus Pharmaceuticals USA Inc.)
FDA approves the original ANDA for ramelteon from Zydus Pharmaceuticals USA Inc., enabling a generic version of this insomnia medication. Ra…
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FDA approval · 2019-03-27FDA Approved: DOXEPIN HYDROCHLORIDE — Original Application (Aurobindo Pharma Limited)
FDA approved the original application for doxepin hydrochloride from Aurobindo Pharma Limited, granting generic approval for this product.
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FDA approval · 2019-02-26FDA Approved: HYDROXYZINE HYDROCHLORIDE — Original Application (APOZEAL PHARMACEUTICALS INC)
The FDA approved APOZEAL Pharmaceuticals' original application for hydroxyzine hydrochloride, establishing a generic version of this antihis…
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FDA approval · 2019-02-06FDA Approved: AMBIEN — Supplemental Application (Cosette Pharmaceuticals, Inc.)
The FDA approved a supplemental application for AMBIEN (zolpidem tartrate) submitted by Cosette Pharmaceuticals, Inc.
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FDA approval · 2019-02-06FDA Approved: ZOLPIDEM TARTRATE — Supplemental Application (Sanofi-Aventis U.S. LLC)
FDA approved a supplemental application for zolpidem tartrate (Ambien) submitted by Sanofi-Aventis U.S. LLC.
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FDA approval · 2019-02-06FDA Approved: HALCION — Supplemental Application (Pharmacia & Upjohn Company LLC)
The FDA approved a supplemental application for HALCION (triazolam) filed by Pharmacia & Upjohn Company LLC.
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FDA approval · 2019-02-06FDA Approved: RESTORIL — Supplemental Application (SpecGx LLC)
The FDA approved a supplemental application for Restoril (temazepam) submitted by SpecGx LLC.
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FDA approval · 2019-02-06FDA Approved: FLURAZEPAM HYDROCHLORIDE — Supplemental Application (Chartwell RX, LLC)
FDA approved a supplemental application for Flurazepam Hydrochloride filed by Chartwell RX, LLC.
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FDA approval · 2019-02-06FDA Approved: LUNESTA — Supplemental Application (Waylis Therapeutics LLC)
The FDA approved a supplemental application for LUNESTA (eszopiclone) submitted by Waylis Therapeutics LLC.
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FDA approval · 2019-02-06FDA Approved: ESTAZOLAM — Supplemental Application (Novitium Pharma LLC)
The FDA approved a supplemental application for ESTAZOLAM (Estazolam) by Novitium Pharma LLC under an ANDA, authorizing changes to the appro…
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FDA approval · 2019-01-16FDA Approved: ESTAZOLAM — Supplemental Application (Actavis Pharma, Inc.)
FDA approved a supplemental application for ESTAZOLAM (Estazolam) from Actavis Pharma, Inc. for the generic product. The approval confirms t…
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FDA approval · 2018-12-21FDA Approved: ROZEREM — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approved a supplemental application for ROZEREM (ramelteon) submitted by Takeda Pharmaceuticals America, Inc.
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FDA approval · 2018-11-30FDA Approved: DIPHENHYDRAMINE HYDROCHLORIDE — Supplemental Application (Armas Pharmaceuticals Inc.)
FDA approved a supplemental application for diphenhydramine hydrochloride from Armas Pharmaceuticals Inc.
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FDA approval · 2018-11-23FDA Approved: TEMAZEPAM — Original Application (Alembic Pharmaceuticals Limited)
FDA approved Alembic Pharmaceuticals Limited's Original Application for Temazepam, a generic benzodiazepine hypnotic used for short-term tre…
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FDA approval · 2018-11-07FDA Approved: LUNESTA — Supplemental Application (Waylis Therapeutics LLC)
FDA approved a supplemental application for LUNESTA (eszopiclone) submitted by Waylis Therapeutics LLC.
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FDA approval · 2018-10-24FDA Approved: EDLUAR — Supplemental Application (Viatris Specialty LLC)
FDA approved a supplemental application for Edluar (zolpidem tartrate) submitted by Viatris Specialty LLC.
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FDA approval · 2018-10-23FDA Approved: NAPROXEN SODIUM PM — Original Application (Strategic Sourcing Services LLC)
FDA approved Naproxen Sodium PM, a combination of naproxen sodium and diphenhydramine, under an Original Application by Strategic Sourcing S…
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FDA approval · 2018-09-14FDA Approved: AMBIEN — Supplemental Application (Cosette Pharmaceuticals, Inc.)
FDA approved a supplemental application for Ambien (zolpidem tartrate) by Cosette Pharmaceuticals, Inc. The approval concerns a modification…
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FDA approval · 2018-08-22FDA Approved: DIPHENHYDRAMINE HYDROCHLORIDE — Original Application (Armas Pharmaceuticals Inc.)
FDA approved the original generic application for diphenhydramine hydrochloride from Armas Pharmaceuticals, making a generic diphenhydramine…
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FDA approval · 2018-07-12FDA Approved: BELSOMRA — Supplemental Application (Merck Sharp & Dohme LLC)
FDA approved a supplemental application for BELSOMRA (suvorexant) from Merck Sharp & Dohme LLC.
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FDA approval · 2018-04-18FDA Approved: ADVIL PM- DIPHENHYDRAMINE CITRATE AND IBUPROFEN TABLET, COATED — Supplemental Application (Lil Drug Store Products, Inc)
FDA approved a supplemental NDA to add Advil PM (ibuprofen and diphenhydramine citrate) in a coated tablet formulation manufactured by Lil D…