Pruritus
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Sign up freeTop drugs studied for this disease
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FDA approval · 2025-12-16FDA Approved: HYDROXYZINE HYDROCHLORIDE — Original Application (ANI Pharmaceuticals, Inc.)
FDA approves ANI Pharmaceuticals' hydroxyzine hydrochloride as a generic product via an Original Application (ANDA 219648), authorizing mark…
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EMA approval · 2025-07-11EMA Authorised: Kayfanda (odevixibat sesquihydrate) — Ipsen Pharma
The EMA authorised Kayfanda (odevixibat sesquihydrate) for pruritus and Alagille syndrome, manufactured by Ipsen Pharma.
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FDA approval · 2023-08-17FDA Approved: HYDROXYZINE HYDROCHLORIDE — Original Application (Rising Pharma Holdings, Inc.)
FDA approved an original application for hydroxyzine hydrochloride from Rising Pharma Holdings, Inc., confirming a generic antihistamine pro…
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FDA approval · 2021-02-16FDA Approved: HYDROXYZINE PAMOATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved Teva Pharmaceuticals USA, Inc.'s supplemental application for hydroxyzine pamoate.
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FDA approval · 2020-03-17FDA 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…
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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 · 2017-05-19FDA Approved: CYPROHEPTADINE HYDROCHLORIDE — Original Application (Zydus Pharmaceuticals USA Inc.)
FDA approved a generic cyproheptadine hydrochloride product from Zydus Pharmaceuticals USA Inc (ANDA 208938). Indications include relief of …
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FDA approval · 2016-11-08FDA Approved: HYDROXYZINE HYDROCHLORIDE — Supplemental Application (Chartwell RX, LLC)
The FDA approved a supplemental application for hydroxyzine hydrochloride from Chartwell RX, LLC, authorizing a generic version under ANDA04…
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FDA approval · 2016-11-08FDA Approved: HYDROXYZINE HYDROCHLORIDE — Supplemental Application (Chartwell RX, LLC)
The FDA approved a supplemental application for hydroxyzine hydrochloride by Chartwell RX, LLC.
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FDA approval · 2016-11-08FDA Approved: HYDROXYZINE HYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved Teva's supplemental application for hydroxyzine hydrochloride, confirming approval of an additional submission for this generic…
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FDA approval · 2016-11-08FDA Approved: HYDROXYZINE HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals LLC)
FDA approved a supplemental ANDA for hydroxyzine hydrochloride by Amneal Pharmaceuticals LLC, authorizing the generic product under the appr…
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FDA approval · 2016-03-30FDA Approved: HYDROXYZINE HYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for hydroxyzine hydrochloride by Teva Pharmaceuticals USA, Inc., under ANDA088617.
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FDA approval · 2016-03-30FDA Approved: HYDROXYZINE HYDROCHLORIDE — Supplemental Application (Chartwell RX, LLC)
FDA approved a supplemental application for hydroxyzine hydrochloride (HYDROXYZINE HYDROCHLORIDE) from Chartwell RX, LLC. This approval allo…
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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 · 2016-03-30FDA Approved: HYDROXYZINE HYDROCHLORIDE — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for hydroxyzine hydrochloride (generic) from Aurobindo Pharma Limited, expanding approval of a gener…
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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 · 2015-01-24FDA Approved: HYDROXYZINE PAMOATE — Supplemental Application (Sandoz Inc)
The FDA approved a supplemental application for hydroxyzine pamoate submitted by Sandoz Inc (ANDA).
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FDA approval · 2014-08-20FDA Approved: HYDROXYZINE HYDROCHLORIDE — Original Application (Chartwell RX, LLC)
FDA approved hydroxyzine hydrochloride from Chartwell RX, LLC under an original ANDA (ApplNo=ANDA204279).
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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 · 2014-06-05FDA Approved: HYDROXYZINE HYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for hydroxyzine hydrochloride (Teva Pharmaceuticals USA, Inc.) under ANDA088617, adding a supplement…
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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 · 2013-07-22FDA Approved: HYDROXYZINE PAMOATE — Supplemental Application (Sandoz Inc)
The FDA approved a supplemental application for hydroxyzine pamoate submitted by Sandoz Inc. The action relates to a generic product under A…
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FDA approval · 2013-06-27FDA Approved: HYDROXYZINE PAMOATE — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application from Sandoz Inc for hydroxyzine pamoate (ANDA 087479), authorizing the generic product under the app…