Insomnia
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Sign up freeTop drugs studied for this disease
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FDA approval · 2015-01-30FDA Approved: ESZOPICLONE — Original Application (Macleods Pharmaceuticals Limited)
The FDA approved Macleods Pharmaceuticals Limited's generic eszopiclone as an original ANDA for the treatment of insomnia. This marks the ap…
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FDA approval · 2015-01-24FDA Approved: HYDROXYZINE PAMOATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved Teva’s supplemental application for hydroxyzine pamoate, confirming its status as an approved generic drug. The action rela…
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FDA approval · 2015-01-02FDA Approved: ZOLPIDEM TARTRATE — Supplemental Application (Sandoz Inc)
The FDA approved a supplemental application for zolpidem tartrate filed by Sandoz Inc., authorizing changes to an existing zolpidem tartrate…
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FDA approval · 2014-12-24FDA Approved: ZOLPIDEM TARTRATE — Supplemental Application (Torrent Pharmaceuticals Limited)
The FDA approved a supplemental application for zolpidem tartrate by Torrent Pharmaceuticals Limited, authorizing a generic formulation for …
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FDA approval · 2014-12-22FDA Approved: ESZOPICLONE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for Eszopiclone from Teva Pharmaceuticals USA, Inc., related to the approved product.
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FDA approval · 2014-12-05FDA Approved: ESZOPICLONE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved Teva Pharmaceuticals USA, Inc.'s supplemental application for eszopiclone. This action represents a supplemental approval for t…
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FDA approval · 2014-12-05FDA Approved: ESZOPICLONE — Supplemental Application (Glenmark Pharmaceuticals Inc. USA)
The FDA approved a supplemental application for eszopiclone submitted by Glenmark Pharmaceuticals Inc. USA.
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FDA approval · 2014-11-07FDA Approved: BELSOMRA — Supplemental Application (Merck Sharp & Dohme LLC)
The FDA approved a supplemental application for BELSOMRA (suvorexant) from Merck Sharp & Dohme LLC, resulting in an updated labeling for the…
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FDA approval · 2014-11-03FDA Approved: LUNESTA — Supplemental Application (Waylis Therapeutics LLC)
The FDA approved a supplemental application for Lunesta (eszopiclone) from Waylis Therapeutics LLC. The action involves changes to Lunesta's…
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FDA approval · 2014-10-29FDA 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 · 2014-10-09FDA Approved: ULTRA SLEEP AID — Supplemental Application (Walgreen Company)
FDA approved a supplemental application for Ultra Sleep Aid, containing doxylamine succinate, submitted by Walgreens Company.
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FDA approval · 2014-10-07FDA Approved: AMBIEN — Supplemental Application (Cosette Pharmaceuticals, Inc.)
The FDA approved a supplemental application for Ambien (zolpidem tartrate) from Cosette Pharmaceuticals, Inc.
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FDA approval · 2014-10-07FDA 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, expanding the product's regulatory label…
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FDA approval · 2014-09-18FDA Approved: HALCION — Supplemental Application (Pharmacia & Upjohn Company LLC)
FDA approved a supplemental application for Halcion (triazolam) from Pharmacia & Upjohn Company LLC.
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FDA approval · 2014-08-13FDA Approved: BELSOMRA — Original Application (Merck Sharp & Dohme LLC)
FDA approved BELSOMRA (suvorexant) as an original application for the treatment of insomnia in adults. BELSOMRA is a dual orexin receptor an…
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FDA approval · 2014-08-08FDA Approved: SILENOR — Supplemental Application (Currax Pharmaceuticals LLC)
FDA approves a supplemental application for Silenor (doxepin hydrochloride) from Currax Pharmaceuticals LLC.
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FDA approval · 2014-06-10FDA Approved: ESZOPICLONE — Original Application (Bionpharma Inc.)
FDA approved Bionpharma Inc.'s Original Application for eszopiclone, granting generic approval for eszopiclone tablets used to treat insomni…
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FDA approval · 2014-06-05FDA Approved: HYDROXYZINE HYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved a supplemental application for Hydroxyzine Hydrochloride from Teva Pharmaceuticals USA, Inc., granting regulatory clearance…
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FDA approval · 2014-06-04FDA Approved: HYDROXYZINE HYDROCHLORIDE — Supplemental Application (KVK-Tech, Inc.)
FDA approved a supplemental application for hydroxyzine hydrochloride from KVK-Tech, Inc., indicating updated regulatory authorization for t…
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FDA approval · 2014-06-04FDA Approved: HYDROXYZINE HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals LLC)
FDA approved Amneal Pharmaceuticals LLC's supplemental application for hydroxyzine hydrochloride, authorizing changes to the approved produc…
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FDA approval · 2014-06-03FDA Approved: HYDROXYZINE HYDROCHLORIDE — Supplemental Application (Chartwell RX, LLC)
FDA approved a supplemental application for hydroxyzine hydrochloride (HYDROXYZINE HYDROCHLORIDE) from Chartwell RX, LLC.
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FDA approval · 2014-05-29FDA Approved: LUNESTA — Supplemental Application (Waylis Therapeutics LLC)
The FDA approved a supplemental application for LUNESTA (eszopiclone) submitted by Waylis Therapeutics LLC. This action grants an additional…
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FDA approval · 2014-05-15FDA 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 · 2014-05-13FDA Approved: LORAZEPAM — Supplemental Application (Hospira, Inc.)
The FDA approved a supplemental application for lorazepam by Hospira, Inc.
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FDA approval · 2014-04-15FDA Approved: ESZOPICLONE — Original Application (Glenmark Pharmaceuticals Inc. USA)
FDA approved eszopiclone from Glenmark as an original generic application, enabling a generic version of the insomnia medication to enter th…