Insomnia
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Sign up freeTop drugs studied for this disease
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FDA approval · 2016-03-30FDA Approved: HYDROXYZINE HYDROCHLORIDE — Supplemental Application (American Regent, Inc.)
The FDA approved a supplemental application for hydroxyzine hydrochloride from American Regent, Inc., finalizing an update to the generic pr…
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FDA approval · 2016-03-15FDA Approved: ADVIL PM- DIPHENHYDRAMINE CITRATE AND IBUPROFEN TABLET, COATED — Supplemental Application (Lil Drug Store Products, Inc)
FDA approved a supplemental application for Advil PM tablets (ibuprofen and diphenhydramine citrate), expanding labeling to include this com…
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FDA approval · 2016-01-20FDA Approved: DOXEPIN — Original Application (North Star Rx LLC)
FDA approved North Star Rx LLC's generic doxepin through an Original Application, marking the approval of a generic doxepin product.
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FDA approval · 2015-12-15FDA Approved: HALCION — Supplemental Application (Pharmacia & Upjohn Company LLC)
FDA approved a supplemental application for HALCION (triazolam) submitted by Pharmacia & Upjohn Company LLC.
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FDA approval · 2015-11-05FDA Approved: ZOLPIDEM TARTRATE — Supplemental Application (Lupin Pharmaceuticals, Inc.)
The FDA approved a supplemental application for zolpidem tartrate from Lupin Pharmaceuticals (ANDA 078970). This action approves an updated/…
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FDA approval · 2015-10-28FDA Approved: ALEVE PM — Supplemental Application (Bayer HealthCare LLC.)
FDA approved a supplemental application for ALEVE PM (diphenhydramine hydrochloride and naproxen sodium) to support its continued marketing …
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FDA approval · 2015-08-27FDA 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 · 2015-08-19FDA Approved: RAMELTEON — Original Application (Actavis Pharma, Inc.)
FDA approved ramelteon (Actavis Pharma) for treatment of insomnia characterized by difficulty with sleep onset.
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FDA approval · 2015-08-14FDA Approved: ALEVE PM — Supplemental Application (Bayer HealthCare LLC.)
FDA approved a supplemental application for Aleve PM, a diphenhydramine HCl and naproxen sodium combination from Bayer HealthCare LLC. The a…
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FDA approval · 2015-06-04FDA Approved: TEMAZEPAM — Original Application (Solco Healthcare U.S., LLC)
FDA approved the original generic application for Temazepam from Solco Healthcare U.S., LLC (ANDA201781).
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FDA approval · 2015-06-03FDA Approved: ZOLPIDEM TARTRATE — Original Application (Lupin Pharmaceuticals,Inc.)
FDA approves Lupin Pharmaceuticals' zolpidem tartrate Original Application (ANDA204299), a generic zolpidem tartrate product. It is intended…
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FDA approval · 2015-06-01FDA Approved: ZOLPIDEM — Supplemental Application (ACI Healthcare USA, Inc)
FDA approved a supplemental application for zolpidem tartrate from ACI Healthcare USA, Inc., granting approval of a generic zolpidem product…
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FDA approval · 2015-04-30FDA Approved: BELSOMRA — Supplemental Application (Merck Sharp & Dohme LLC)
FDA approved a supplemental application for BELSOMRA (suvorexant) submitted by Merck Sharp & Dohme LLC.
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FDA approval · 2015-04-07FDA Approved: ADVIL PM- DIPHENHYDRAMINE CITRATE AND IBUPROFEN TABLET, COATED — Supplemental Application (Lil Drug Store Products, Inc)
The FDA approved a supplemental NDA for Advil PM comprising ibuprofen and diphenhydramine citrate tablets (coated) from Lil Drug Store Produ…
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FDA approval · 2015-03-19FDA Approved: ZOLPIDEM TARTRATE — Supplemental Application (NorthStar Rx LLC)
FDA approved a supplemental application for zolpidem tartrate submitted by NorthStar Rx LLC, resulting in approval of an additional zolpidem…
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FDA approval · 2015-03-19FDA Approved: ESZOPICLONE — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved Lupin Pharmaceuticals' supplemental application for a generic eszopiclone product, confirming approval to market a generic vers…
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FDA approval · 2015-03-19FDA Approved: ZOLPIDEM TARTRATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved Teva's supplemental application for zolpidem tartrate, expanding the approved formulation/use for treating insomnia.
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FDA approval · 2015-03-19FDA Approved: ZOLPIDEM TARTRATE — Supplemental Application (Sandoz Inc)
The FDA approved a supplemental application for zolpidem tartrate from Sandoz Inc, approving changes to an existing generic product.
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FDA approval · 2015-03-19FDA Approved: ZOLPIDEM TARTRATE — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved a supplemental application for Zolpidem Tartrate from Lupin Pharmaceuticals, Inc., approving a generic zolpidem tartrate produc…
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FDA approval · 2015-03-06FDA Approved: ULTRA SLEEP AID — Supplemental Application (Walgreen Company)
The FDA approved a supplemental application for ULTRA SLEEP AID containing doxylamine succinate, submitted by Walgreens Company. This action…
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FDA approval · 2015-02-27FDA Approved: ESZOPICLONE — Supplemental Application (Dr. Reddy's Laboratories Limited)
The FDA approved a supplemental application for eszopiclone filed by Dr. Reddy's Laboratories Limited, approving a generic version of the sl…
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FDA approval · 2015-02-25FDA Approved: ALEVE PM — Supplemental Application (Bayer HealthCare LLC.)
The FDA approved a supplemental application for Aleve PM (diphenhydramine hydrochloride and naproxen sodium) from Bayer HealthCare LLC. The …
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FDA approval · 2015-02-16FDA 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 · 2015-02-13FDA Approved: ESZOPICLONE — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for eszopiclone filed by Mylan Pharmaceuticals Inc., signaling a modification to the existing approv…
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FDA approval · 2015-01-30FDA Approved: ESZOPICLONE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
The FDA approved a supplemental application for eszopiclone filed by Sun Pharmaceutical Industries, Inc., signaling approval of a regulatory…