Insomnia
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Sign up freeTop drugs studied for this disease
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FDA approval · 2009-05-19FDA Approved: ADVIL PM — Supplemental Application (Haleon US Holdings LLC)
FDA approved a supplemental application for Advil PM (diphenhydramine HCl and ibuprofen) submitted by Haleon US Holdings LLC.
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FDA approval · 2009-04-23FDA 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 · 2009-04-06FDA 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 · 2009-03-31FDA Approved: TEMAZEPAM — Supplemental Application (Actavis Pharma, Inc.)
FDA approved a supplemental application for Temazepam from Actavis Pharma, Inc., indicating approval of an additional aspect of the product'…
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FDA approval · 2009-03-13FDA Approved: EDLUAR — Original Application (Viatris Specialty LLC)
The FDA approved EDLUAR (zolpidem tartrate) through Viatris Specialty LLC's original NDA (NDA021997) for the treatment of insomnia.
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FDA approval · 2009-03-10FDA Approved: ZOLPIDEM TARTRATE — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application for zolpidem tartrate from Sandoz Inc, signaling an approval related to a generic product under an A…
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FDA approval · 2009-01-23FDA Approved: ZOLPIDEM TARTRATE — Supplemental Application (NorthStar Rx LLC)
The FDA approved a supplemental application for zolpidem tartrate from NorthStar Rx LLC under ANDA078413, enabling its continued marketing a…
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FDA approval · 2009-01-08FDA Approved: ESTAZOLAM — Supplemental Application (Dr. Reddy's Labratories Inc.)
The FDA approved a supplemental application for estazolam by Dr. Reddy's Laboratories Inc. (ANDA074921).
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FDA approval · 2008-11-06FDA Approved: ZOLPIDEM TARTRATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for zolpidem tartrate by Teva Pharmaceuticals USA, Inc., indicating an approved change to the produc…
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FDA approval · 2008-10-20FDA Approved: ROZEREM — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for ROZEREM (ramelteon) submitted by Takeda Pharmaceuticals America, Inc., resulting in a labeli…
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FDA approval · 2008-10-14FDA Approved: ESTAZOLAM — Supplemental Application (Actavis Pharma, Inc.)
FDA approved a supplemental application for ESTAZOLAM from Actavis Pharma, Inc., authorizing the ESTAZOLAM product under the approved drug f…
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FDA approval · 2008-09-10FDA Approved: LORAZEPAM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved a supplemental application for lorazepam submitted by Teva Pharmaceuticals USA, Inc., under the existing approval of the dr…
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FDA approval · 2008-09-09FDA Approved: ESTAZOLAM — Supplemental Application (Novitium Pharma LLC)
FDA approved a supplemental ANDA for ESTAZOLAM by Novitium Pharma LLC. Estazolam is a prescription sleep aid used to treat insomnia.
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FDA approval · 2008-09-03FDA Approved: ZOLPIDEM — Supplemental Application (ACI Healthcare USA, Inc)
FDA approved a supplemental application for Zolpidem tartrate by ACI Healthcare USA, Inc.
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FDA approval · 2008-08-20FDA Approved: ESTAZOLAM — Supplemental Application (Actavis Pharma, Inc.)
FDA approved a supplemental application for ESTAZOLAM from Actavis Pharma, Inc., related to the generic insomnia medication estazolam.
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FDA approval · 2008-07-14FDA Approved: ULTRA SLEEP AID — Supplemental Application (Walgreen Company)
The FDA approved a supplemental application for Ultra Sleep Aid (doxylamine succinate) from Walgreens Company.
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FDA approval · 2008-07-14FDA Approved: DOXEPIN HYDROCHLORIDE — Supplemental Application (Lannett Company, Inc.)
FDA approved Lannett's supplemental application for doxepin hydrochloride, confirming a generic version is approvable. The product will carr…
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FDA approval · 2008-06-06FDA Approved: ZALEPLON — Original Application (Rising Pharma Holdings, Inc.)
FDA approved Rising Pharma Holdings, Inc.'s original ANDA for Zaleplon, a generic short-acting hypnotic used to treat insomnia.
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FDA approval · 2008-06-06FDA Approved: ZALEPLON — Original Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved Hikma Pharmaceuticals USA Inc.'s generic Zaleplon via an Original Application, adding a generic option for this sleep medic…
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FDA approval · 2008-06-06FDA Approved: ZALEPLON — Original Application (Unichem Pharmaceuticals (USA), Inc.)
FDA approved Unichem Pharmaceuticals (USA), Inc.'s original ANDA for Zaleplon, a generic version of the sleep medication. This marks the ava…
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FDA approval · 2008-05-29FDA Approved: ZOLPIDEM — Supplemental Application (ACI Healthcare USA, Inc)
FDA approves a supplemental application for zolpidem tartrate (Zolpidem) submitted by ACI Healthcare USA, Inc. The action represents an appr…
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FDA approval · 2008-05-23FDA Approved: ZOLPIDEM TARTRATE — Supplemental Application (Sandoz Inc)
The FDA approved a supplemental application for zolpidem tartrate from Sandoz Inc, indicating regulatory action on a generic zolpidem produc…
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FDA approval · 2008-05-13FDA Approved: ZOLPIDEM TARTRATE — Supplemental Application (Sandoz Inc)
FDA approves a supplemental application for zolpidem tartrate by Sandoz Inc, indicating a modification/added aspect to the approved generic …
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FDA approval · 2008-05-07FDA Approved: AMBIEN — Supplemental Application (Cosette Pharmaceuticals, Inc.)
The FDA approved a supplemental application for AMBIEN (zolpidem tartrate) filed by Cosette Pharmaceuticals, Inc.
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FDA approval · 2008-03-31FDA Approved: HYDROXYZINE HYDROCHLORIDE — Original Application (Northstar RxLLC)
FDA approved Northstar RxLLC's Original Application for hydroxyzine hydrochloride, a generic antihistamine product.