Benign Prostatic Hyperplasia
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Sign up freeTop drugs studied for this disease
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FDA approval · 2019-02-05FDA Approved: TADALAFIL — Original Application (Dr.Reddys Laboratories Inc)
FDA approved Dr. Reddy's Laboratories' tadalafil as an original application (ANDA) generic product.
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FDA approval · 2019-02-05FDA Approved: TADALAFIL — Original Application (Camber Pharmaceuticals, Inc.)
FDA approved Camber Pharmaceuticals' original application for tadalafil, a generic version of the erectile dysfunction medication Cialis.
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FDA approval · 2018-12-10FDA Approved: SILODOSIN — Original Application (Aurobindo Pharma Limited)
FDA approved an original application for silodosin from Aurobindo Pharma Limited as a generic treatment for symptoms of benign prostatic hyp…
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FDA approval · 2018-12-07FDA Approved: ALFUZOSIN HYDROCHLORIDE — Supplemental Application (Aurobindo Pharma Limited)
The FDA approved a supplemental application for Alfuzosin hydrochloride from Aurobindo Pharma Limited. Alfuzosin hydrochloride is approved a…
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FDA approval · 2018-12-07FDA Approved: ALFUZOSIN HYDROCHLORIDE — Supplemental Application (Apotex Corp.)
The FDA approved a supplemental application for alfuzosin hydrochloride from Apotex Corp., indicating an updated or expanded aspect of the a…
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FDA approval · 2018-12-07FDA Approved: ALFUZOSIN HYDROCHLORIDE — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)
FDA approved a supplemental application for alfuzosin hydrochloride (generic) from Unichem Pharmaceuticals (USA), Inc., to support changes t…
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FDA approval · 2018-12-03FDA Approved: SILODOSIN — Original Application (Lupin Pharmaceuticals, Inc.)
The FDA approved Lupin Pharmaceuticals' original ANDA for silodosin, the generic form of the drug used to treat benign prostatic hyperplasia…
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FDA approval · 2018-12-03FDA Approved: SILODOSIN — Original Application (Novadoz Pharmaceuticals LLC)
FDA approved the original ANDA for silodosin as a generic product from Novadoz Pharmaceuticals LLC.
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FDA approval · 2018-12-03FDA Approved: SILODOSIN — Original Application (Ajanta Pharma USA Inc.)
FDA approves the original Abbreviated New Drug Application for generic silodosin from Ajanta Pharma USA Inc. for the treatment of symptoms o…
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FDA approval · 2018-12-03FDA Approved: SILODOSIN — Original Application (Macleods Pharmaceuticals Limited)
FDA approved Macleods Pharmaceuticals Limited's generic silodosin for the treatment of lower urinary tract symptoms due to benign prostatic …
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FDA approval · 2018-12-03FDA Approved: SILODOSIN — Original Application (Amneal Pharmaceuticals NY LLC)
FDA approved Amneal Pharmaceuticals NY LLC's original application for silodosin (generic) for the treatment of benign prostatic hyperplasia.
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FDA approval · 2018-11-14FDA Approved: ALFUZOSIN HYDROCHLORIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved a supplemental application for alfuzosin hydrochloride by Sun Pharmaceutical Industries, Inc.
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FDA approval · 2018-05-24FDA Approved: DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE — Original Application (Zydus Pharmaceuticals USA Inc.)
FDA approved the generic fixed-dose combination dutasteride and tamsulosin hydrochloride from Zydus Pharmaceuticals USA Inc. (Original Appli…
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FDA approval · 2018-05-14FDA Approved: UROXATRAL — Supplemental Application (Advanz Pharma (US) Corp.)
The FDA approved a supplemental application for UROXATRAL (alfuzosin HCl) from Advanz Pharma US Corp.
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FDA approval · 2018-04-17FDA Approved: DOXAZOSIN — Original Application (Upsher-Smith laboratories, LLC)
The FDA granted approval of Upsher-Smith's original application for doxazosin mesylate, making doxazosin available as a generic product. Dox…
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FDA approval · 2018-02-13FDA Approved: DOXAZOSIN — Original Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)
FDA approved an original application for doxazosin (generic), manufactured by Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.,…
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FDA approval · 2017-11-21FDA Approved: DUTASTERIDE — Original Application (Epic Pharma, LLC)
FDA approved the original application for dutasteride by Epic Pharma, LLC, enabling a generic version of dutasteride to be marketed in the U…
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FDA approval · 2017-11-01FDA Approved: JALYN — Supplemental Application (Waylis Therapeutics)
The FDA approved a supplemental application for JALYN (dutasteride and tamsulosin hydrochloride) submitted by Waylis Therapeutics.
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FDA approval · 2017-09-29FDA Approved: DOXAZOSIN — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approves Teva's supplemental application for doxazosin (doxazosin mesylate) under ANDA075536.
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FDA approval · 2017-08-11FDA Approved: TAMSULOSIN HYDROCHLORIDE — Original Application (Ascend Laboratories, LLC)
FDA approved Ascend Laboratories' generic tamsulosin hydrochloride via an original ANDA for the treatment of benign prostatic hyperplasia.
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FDA approval · 2017-07-07FDA Approved: DOXAZOSIN — Original Application (Zydus Lifesciences Limited)
FDA approved the original application for generic doxazosin from Zydus Lifesciences Limited. This product provides a generic option for the …
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FDA approval · 2017-06-26FDA Approved: TAMSULOSIN HYDROCHLORIDE — Supplemental Application (Macleods Pharmaceuticals Limited)
FDA approved a supplemental application for Tamsulosin hydrochloride from Macleods Pharmaceuticals Limited (ANDA 204645).
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FDA approval · 2017-05-05FDA Approved: CIALIS — Supplemental Application (Eli Lilly and Company)
The FDA approved a supplemental application for Cialis (tadalafil) submitted by Eli Lilly and Company.
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FDA approval · 2017-03-08FDA Approved: FINASTERIDE — Supplemental Application (Ascend Laboratories, LLC)
FDA approves a supplemental application for finasteride filed by Ascend Laboratories, LLC under an ANDA.
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FDA approval · 2017-02-27FDA Approved: CARDURA XL — Supplemental Application (Viatris Specialty LLC)
The FDA approved a supplemental application for Cardura XL (doxazosin mesylate) from Viatris Specialty LLC.