Benign Prostatic Hyperplasia
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Sign up freeTop drugs studied for this disease
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FDA approval · 2011-09-27FDA Approved: FINASTERIDE — Supplemental Application (Aurobindo Pharma Limited)
The FDA approved a supplemental application for a Finasteride product manufactured by Aurobindo Pharma Limited, expanding access to a generi…
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FDA approval · 2011-09-27FDA Approved: FINASTERIDE — Supplemental Application (Accord Healthcare, Inc.)
The FDA approved a supplemental application for finasteride from Accord Healthcare, Inc.
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FDA approval · 2011-08-29FDA Approved: TAMSULOSIN HYDROCHLORIDE — Supplemental Application (Zydus Lifesciences Limited)
FDA approved a supplemental application for Tamsulosin Hydrochloride from Zydus Lifesciences Limited, authorizing changes under an already a…
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FDA approval · 2011-08-25FDA Approved: FINASTERIDE — Supplemental Application (Dr. Reddy's Laboratories Limited)
The FDA approved a supplemental application for finasteride submitted by Dr. Reddy's Laboratories Limited.
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FDA approval · 2011-08-11FDA Approved: FINASTERIDE — Supplemental Application (Dr. Reddy's Laboratories Limited)
The FDA approved a supplemental application for Finasteride from Dr. Reddy's Laboratories Limited, granting approval for the generic product…
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FDA approval · 2011-08-03FDA Approved: FINASTERIDE — Supplemental Application (Dr. Reddy's Laboratories Limited)
FDA granted a supplemental approval for Finasteride from Dr. Reddy's Laboratories Limited, resulting in changes to the product labeling unde…
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FDA approval · 2011-07-26FDA Approved: FINASTERIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved a supplemental application for finasteride submitted by Teva Pharmaceuticals USA, updating the product’s labeling.
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FDA approval · 2011-07-18FDA Approved: ALFUZOSIN HYDROCHLORIDE — Original Application (Apotex Corp.)
FDA approved Apotex Corp.'s alfuzosin hydrochloride as an original application generic product.
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FDA approval · 2011-07-18FDA Approved: ALFUZOSIN HYDROCHLORIDE — Original Application (Sun Pharmaceutical Industries, Inc.)
FDA approved the original application for Alfuzosin hydrochloride (generic) submitted by Sun Pharmaceutical Industries, Inc. for the treatme…
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FDA approval · 2011-07-08FDA Approved: DOXAZOSIN — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for doxazosin (doxazosin mesylate) from Aurobindo Pharma Limited, updating the approved generic prod…
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FDA approval · 2011-07-08FDA Approved: CARDURA XL — Supplemental Application (Viatris Specialty LLC)
FDA approved a supplemental application for Cardura XL (doxazosin mesylate) filed by Viatris Specialty LLC.
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FDA approval · 2011-06-28FDA Approved: FINASTERIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for Finasteride filed by Teva Pharmaceuticals USA, Inc. The approval confirms the supplemental chang…
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FDA approval · 2011-06-10FDA Approved: PROSCAR — Supplemental Application (Organon LLC)
FDA approved a supplemental application for PROSCAR (finasteride) submitted by Organon LLC.
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FDA approval · 2011-06-09FDA Approved: AVODART — Supplemental Application (Waylis Therapeutics LLC)
FDA approves a supplemental application for AVODART (dutasteride) submitted by Waylis Therapeutics LLC under NDA 021319.
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FDA approval · 2011-06-09FDA Approved: JALYN — Supplemental Application (Waylis Therapeutics)
FDA approved a supplemental application for JALYN, a fixed-dose combination of dutasteride and tamsulosin hydrochloride manufactured by Wayl…
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FDA approval · 2011-05-04FDA Approved: TAMSULOSIN HYDROCHLORIDE — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application for tamsulosin hydrochloride (generic) from Sandoz Inc, granting approval of the generic product.
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FDA approval · 2011-03-01FDA Approved: FINASTERIDE — Supplemental Application (Dr. Reddy's Laboratories Limited)
FDA approved a supplemental application for finasteride submitted by Dr. Reddy's Laboratories Limited (an ANDA supplement/approval).
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FDA approval · 2011-03-01FDA Approved: FINASTERIDE — Supplemental Application (Accord Healthcare, Inc.)
The FDA approved Accord Healthcare, Inc.'s supplemental application for finasteride, authorizing a generic version to be marketed. The produ…
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FDA approval · 2010-12-22FDA Approved: FINASTERIDE — Supplemental Application (Camber Pharmaceuticals, Inc.)
FDA approved a supplemental application for finasteride from Camber Pharmaceuticals, authorizing the marketing of a generic finasteride prod…
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FDA approval · 2010-12-21FDA Approved: FINASTERIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for finasteride from Teva Pharmaceuticals USA, Inc. This action approves changes to the product's la…
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FDA approval · 2010-12-15FDA Approved: UROXATRAL — Supplemental Application (Advanz Pharma (US) Corp.)
FDA approved a Supplemental Application for UROXATRAL (alfuzosin HCl) submitted by Advanz Pharma (US) Corp.
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FDA approval · 2010-10-04FDA Approved: PROSCAR — Supplemental Application (Organon LLC)
FDA approved a supplemental application for PROSCAR (finasteride) from Organon LLC.
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FDA approval · 2010-09-09FDA Approved: AVODART — Supplemental Application (Waylis Therapeutics LLC)
The FDA approved a supplemental application for Avodart (dutasteride) submitted by Waylis Therapeutics LLC.
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FDA approval · 2010-07-16FDA Approved: FINASTERIDE — Supplemental Application (Accord Healthcare, Inc.)
FDA approved a supplemental application for finasteride from Accord Healthcare, Inc., resulting in regulatory approval of a generic finaster…
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FDA approval · 2010-07-15FDA Approved: TAMSULOSIN HYDROCHLORIDE — Original Application (Sun Pharmaceutical Industries, Inc.)
FDA approved a generic version of tamsulosin hydrochloride (Sun Pharmaceutical Industries) through an original ANDA. The product is used to …