Benign Prostatic Hyperplasia
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Sign up freeTop drugs studied for this disease
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FDA approval · 2017-02-21FDA Approved: DOXAZOSIN — Supplemental Application (Accord Healthcare Inc.)
FDA approved a supplemental application for doxazosin from Accord Healthcare Inc. for a generic product. The approval relates to the generic…
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FDA approval · 2017-02-21FDA Approved: DOXAZOSIN — Supplemental Application (Apotex Corp.)
FDA approved Apotex Corp.'s supplemental application for doxazosin, a generic alpha-1 blocker used to treat hypertension and benign prostati…
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FDA approval · 2017-02-21FDA Approved: DOXAZOSIN — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for doxazosin mesylate (doxazosin) submitted by Teva Pharmaceuticals USA, Inc.
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FDA approval · 2017-01-20FDA Approved: TAMSULOSIN HYDROCHLORIDE — Original Application (Macleods Pharmaceuticals Limited)
FDA approved Macleods Pharmaceuticals' original application for tamsulosin hydrochloride, a generic treatment for symptoms of benign prostat…
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FDA approval · 2017-01-06FDA Approved: FINASTERIDE — Original Application (Ascend Laboratories, LLC)
The FDA approved the original Abbreviated New Drug Application for finasteride by Ascend Laboratories, LLC, enabling a generic version of Fi…
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FDA approval · 2017-01-05FDA Approved: FINASTERIDE — Original Application (Ascend Laboratories, LLC)
FDA approved Finasteride under an Original Application for Ascend Laboratories, LLC (ANDA 204304), marking the approval of a generic version…
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FDA approval · 2016-11-22FDA Approved: FINASTERIDE — Supplemental Application (Dr Reddys Laboratories Inc)
The FDA approved a supplemental application for Finasteride from Dr Reddys Laboratories Inc, updating the status of a generic Finasteride pr…
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FDA approval · 2016-10-21FDA Approved: DUTASTERIDE — Original Application (XLCare Pharmaceuticals, Inc.)
The FDA approved XLCare Pharmaceuticals' original application for dutasteride, establishing a generic version of the drug. It is indicated f…
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FDA approval · 2016-06-13FDA Approved: JALYN — Supplemental Application (Waylis Therapeutics)
The FDA approved a supplemental application for Jalyn, the combination of dutasteride and tamsulosin hydrochloride, submitted by Waylis Ther…
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FDA approval · 2016-06-09FDA Approved: DOXAZOSIN — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for doxazosin from Mylan Pharmaceuticals, indicating a labeling or formulation update to the existin…
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FDA approval · 2016-04-22FDA 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 · 2016-03-23FDA Approved: UROXATRAL — Supplemental Application (Advanz Pharma (US) Corp.)
FDA approved a supplemental application for UROXATRAL (alfuzosin hydrochloride) submitted by Advanz Pharma (US) Corp., through a supplementa…
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FDA approval · 2016-02-25FDA Approved: FINASTERIDE — Supplemental Application (Aurobindo Pharma Limited)
The FDA approved a supplemental application for Finasteride from Aurobindo Pharma Limited, enabling a generic Finasteride product.
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FDA approval · 2016-01-28FDA Approved: ALFUZOSIN HYDROCHLORIDE — Original Application (Unichem Pharmaceuticals (USA), Inc.)
FDA approved the original application for alfuzosin hydrochloride (generic) from Unichem Pharmaceuticals (USA), Inc. The approval covers its…
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FDA approval · 2015-12-23FDA Approved: FINASTERIDE — Supplemental Application (Aurobindo Pharma Limited)
The FDA approved a supplemental application for finasteride from Aurobindo Pharma Limited, authorizing the generic finasteride product to be…
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FDA approval · 2015-11-20FDA Approved: DUTASTERIDE — Original Application (Banyan Pharma LLC)
FDA approves Banyan Pharma LLC's generic dutasteride through an Original Application (ANDA).
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FDA approval · 2015-11-20FDA Approved: DUTASTERIDE — Original Application (Aurobindo Pharma Limited)
FDA approves Aurobindo Pharma Limited's original application for dutasteride as a generic version of Avodart.
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FDA approval · 2015-11-20FDA Approved: DUTASTERIDE — Original Application (Amneal Pharmaceuticals LLC)
FDA approves Amneal Pharmaceuticals LLC's original abbreviated new drug application for dutasteride (generic) for use in benign prostatic hy…
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FDA approval · 2015-11-09FDA Approved: TAMSULOSIN HYDROCHLORIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
The FDA approved a supplemental application for tamsulosin hydrochloride from Sun Pharmaceutical Industries, expanding/regulatory approval f…
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FDA approval · 2015-10-30FDA Approved: TAMSULOSIN HYDROCHLORIDE — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application for tamsulosin hydrochloride from Sandoz Inc, updating the approval status for this generic product.
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FDA approval · 2015-09-16FDA Approved: CIALIS — Supplemental Application (Eli Lilly and Company)
The FDA approved Cialis (tadalafil) via a supplemental application submitted by Eli Lilly and Company. The approval updates the labeling and…
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FDA approval · 2015-07-11FDA Approved: TAMSULOSIN HYDROCHLORIDE — Supplemental Application (Aurobindo Pharma Limited)
The FDA approved a supplemental application for tamsulosin hydrochloride from Aurobindo Pharma Limited.
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FDA approval · 2015-07-06FDA Approved: PROSCAR — Supplemental Application (Organon LLC)
FDA approved a supplemental application for PROSCAR (finasteride) submitted by Organon LLC.
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FDA approval · 2015-06-01FDA Approved: ALFUZOSIN HYDROCHLORIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
The FDA approved a supplemental application for Alfuzosin Hydrochloride from Sun Pharmaceutical Industries, Inc., updating the product's reg…
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FDA approval · 2015-04-22FDA Approved: TAMSULOSIN HYDROCHLORIDE — Supplemental Application (Zydus Lifesciences Limited)
The FDA approved a supplemental application for tamsulosin hydrochloride submitted by Zydus Lifesciences Limited.