Onychomycosis
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Sign up freeTop drugs studied for this disease
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FDA approval · 2025-09-12FDA Approved: TERBINAFINE HYDROCHLORIDE — Supplemental Application (Bionpharma Inc.)
FDA approved a supplemental application for Terbinafine hydrochloride from Bionpharma Inc., approving a generic antifungal product under the…
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FDA approval · 2025-03-12FDA Approved: ITRACONAZOLE — Supplemental Application (Ascend Laboratories, LLC)
FDA approved a supplemental application for itraconazole from Ascend Laboratories, LLC, authorizing changes to the generic product under AND…
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FDA approval · 2025-01-29FDA Approved: ITRACONAZOLE — Supplemental Application (Camber Pharmaceuticals, Inc.)
FDA approved a supplemental application for itraconazole by Camber Pharmaceuticals, expanding/updating labeling for the generic product.
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FDA approval · 2024-12-20FDA Approved: TERBINAFINE HYDROCHLORIDE — Supplemental Application (Breckenridge Pharmaceutical, Inc.)
FDA approved a supplemental application for a generic Terbinafine hydrochloride product from Breckenridge Pharmaceutical, Inc.
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FDA approval · 2024-10-24FDA Approved: ITRACONAZOLE — Supplemental Application (Alembic Pharmaceuticals Inc.)
FDA approved a supplemental application for itraconazole from Alembic Pharmaceuticals Inc., resulting in a label-related approval update for…
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FDA approval · 2023-04-10FDA Approved: TAVABOROLE — Original Application (Zydus Lifesciences Limited)
FDA approved Tavaborole as a generic product under ANDA212294 from Zydus Lifesciences Limited for the treatment of onychomycosis.
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FDA approval · 2022-03-31FDA Approved: JUBLIA — Supplemental Application (Bausch Health US LLC)
The FDA approved a supplemental application for JUBLIA (efinaconazole) submitted by Bausch Health US LLC.
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FDA approval · 2021-02-09FDA Approved: TAVABOROLE — Original Application (Cipla USA Inc.)
The FDA approved Cipla USA Inc.'s original generic application for tavaborole, enabling a generic version of tavaborole topical solution for…
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FDA approval · 2021-02-03FDA Approved: TAVABOROLE — Original Application (Chartwell RX, LLC)
FDA approved Tavaborole as a generic product under an Original Application (ANDA 211963) for Chartwell RX, LLC.
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FDA approval · 2020-10-21FDA Approved: TAVABOROLE — Original Application (Alembic Pharmaceuticals Inc.)
FDA approves Tavaborole as a generic product under an Original Application (ANDA) by Alembic Pharmaceuticals Inc., expanding access to treat…
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FDA approval · 2020-10-13FDA Approved: TAVABOROLE — Original Application (Encube Ethicals, Inc.)
ANDA Original Application approved for Tavaborole topical solution 5% by Encube Ethicals, Inc., a generic version of tavaborole for onychomy…
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FDA approval · 2020-04-26FDA Approved: JUBLIA — Supplemental Application (Bausch Health US LLC)
The FDA approved a supplemental application for JUBLIA (efinaconazole) submitted by Bausch Health US LLC.
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FDA approval · 2018-12-26FDA Approved: ULTRAMICROSIZE GRISEOFULVIN — Original Application (Sandoz Inc)
FDA approved a generic version of griseofulvin (Ultramicrosize Griseofulvin) from Sandoz Inc under an Original Application (ANDA 202805) for…
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FDA approval · 2016-09-26FDA Approved: ITRACONAZOLE — Original Application (Amneal Pharmaceuticals LLC)
FDA approved Amneal Pharmaceuticals LLC's original application for itraconazole, granting a generic version of the antifungal medication. Th…
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FDA approval · 2016-09-22FDA Approved: JUBLIA — Supplemental Application (Bausch Health US LLC)
The FDA approved a supplemental application for JUBLIA (efinaconazole) submitted by Bausch Health US LLC to update the product labeling.
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FDA approval · 2016-04-01FDA Approved: JUBLIA — Supplemental Application (Bausch Health US LLC)
FDA approves a supplemental application for JUBLIA (efinaconazole) from Bausch Health US LLC, potentially updating labeling or adding new in…
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FDA approval · 2015-11-05FDA Approved: JUBLIA — Supplemental Application (Bausch Health US LLC)
The FDA approved a supplemental application for JUBLIA (efinaconazole) submitted by Bausch Health US LLC.
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FDA approval · 2015-10-30FDA Approved: ITRACONAZOLE — Original Application (Amneal Pharmaceuticals LLC)
FDA approved Amneal Pharmaceuticals LLC's original ANDA for itraconazole, enabling a generic version of the antifungal agent to be marketed.
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FDA approval · 2015-10-14FDA Approved: CICLOPIROX — Supplemental Application (Padagis Israel Pharmaceuticals Ltd)
FDA approved a supplemental application for Ciclopirox from Padagis Israel Pharmaceuticals Ltd, indicating an update to the product's labeli…
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FDA approval · 2015-10-08FDA Approved: CICLOPIROX — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved a supplemental application for Ciclopirox from Sun Pharmaceutical Industries, Inc., under the ANDA framework. The approval indi…
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FDA approval · 2015-08-26FDA Approved: JUBLIA — Supplemental Application (Bausch Health US LLC)
The FDA approved a supplemental application for JUBLIA (efinaconazole) submitted by Bausch Health US LLC.
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FDA approval · 2015-08-25FDA Approved: TERBINAFINE — Supplemental Application (NorthStar Rx LLC)
FDA approved a supplemental application for terbinafine hydrochloride (NorthStar Rx LLC). This action updates labeling/indications for the p…
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FDA approval · 2015-02-27FDA Approved: JUBLIA — Supplemental Application (Bausch Health US LLC)
The FDA approved a supplemental application for JUBLIA (efinaconazole) submitted by Bausch Health US LLC.
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FDA approval · 2014-12-01FDA Approved: CICLOPIROX — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)
FDA approved a supplemental application for Ciclopirox from Glenmark Pharmaceuticals Inc., USA.
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FDA approval · 2014-06-06FDA Approved: JUBLIA — Original Application (Bausch Health US LLC)
FDA approved JUBLIA (efinaconazole) under an original application for the topical treatment of onychomycosis of the toenails. The product is…