Benign Prostatic Hyperplasia
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Sign up freeTop drugs studied for this disease
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FDA approval · 2015-04-06FDA Approved: FINASTERIDE — Supplemental Application (Camber Pharmaceuticals, Inc.)
FDA approved Camber Pharmaceuticals' supplemental application for Finasteride (generic) under ANDA090061.
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FDA approval · 2015-03-20FDA Approved: TERAZOSIN — Supplemental Application (Jubilant Cadista Pharmacuticals Inc.)
FDA approved a supplemental application for terazosin hydrochloride from Jubilant Cadista Pharmaceuticals Inc., related to the generic teraz…
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FDA approval · 2015-03-19FDA Approved: FINASTERIDE — Supplemental Application (Camber Pharmaceuticals, Inc.)
FDA approved Camber Pharmaceuticals' supplemental application for Finasteride (generic), confirming approval of changes to the product. Fina…
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FDA approval · 2015-02-24FDA Approved: DOXAZOSIN — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for doxazosin mesylate from Aurobindo Pharma Limited.
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FDA approval · 2015-01-15FDA Approved: ALFUZOSIN HYDROCHLORIDE — Supplemental Application (Apotex Corp.)
FDA approved Apotex Corp.'s supplemental application for alfuzosin hydrochloride, a generic product under the ANDA program.
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FDA approval · 2015-01-14FDA Approved: ALFUZOSIN HYDROCHLORIDE — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for Alfuzosin hydrochloride from Aurobindo Pharma Limited, indicating regulatory approval for this g…
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FDA approval · 2015-01-13FDA Approved: ALFUZOSIN HYDROCHLORIDE EXTENDED RELEASE — Supplemental Application (Cipla USA Inc.)
The FDA approved a supplemental application for Alfuzosin Hydrochloride Extended Release by Cipla USA Inc., approving changes to the markete…
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FDA approval · 2014-12-14FDA Approved: FINASTERIDE — Supplemental Application (Dr Reddys Laboratories Inc)
FDA approved a supplemental application for finasteride by Dr Reddys Laboratories Inc, enabling the generic product to be marketed under AND…
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FDA approval · 2014-12-14FDA Approved: FINASTERIDE — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for finasteride from Aurobindo Pharma Limited.
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FDA approval · 2014-12-14FDA Approved: FINASTERIDE — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for finasteride from Aurobindo Pharma Limited under an Abbreviated New Drug Application.
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FDA approval · 2014-12-14FDA Approved: FINASTERIDE — Supplemental Application (Accord Healthcare, Inc.)
FDA approved a supplemental application for finasteride from Accord Healthcare, Inc., granting an approval to modify the product via a suppl…
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FDA approval · 2014-11-03FDA Approved: FINASTERIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved a supplemental application for finasteride by Sun Pharmaceutical Industries, Inc. (ANDA090508). This action grants approval for…
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FDA approval · 2014-09-26FDA Approved: FINASTERIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for finasteride submitted by Teva Pharmaceuticals USA, Inc.
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FDA approval · 2014-09-22FDA Approved: DOXAZOSIN — Supplemental Application (Aurobindo Pharma Limited)
FDA approves a supplemental application for doxazosin mesylate from Aurobindo Pharma Limited under the DOXAZOSIN ANDA, signaling regulatory …
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FDA approval · 2014-09-21FDA Approved: DOXAZOSIN — Supplemental Application (Apotex Corp.)
The FDA approved a supplemental application for doxazosin from Apotex Corp., indicating updated labeling/manufacturing aspects for the gener…
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FDA approval · 2014-09-21FDA Approved: FINASTERIDE — Supplemental Application (Dr. Reddy's Laboratories Limited)
FDA approved a supplemental application for Finasteride submitted by Dr. Reddy's Laboratories Limited. This action refers to a supplemental …
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FDA approval · 2014-07-28FDA Approved: DOXAZOSIN — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for doxazosin from Mylan Pharmaceuticals Inc., signaling a regulatory action that likely updates lab…
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FDA approval · 2014-07-28FDA Approved: CARDURA XL — Supplemental Application (Viatris Specialty LLC)
The FDA approved a supplemental application for Cardura XL (doxazosin mesylate) submitted by Viatris Specialty LLC.
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FDA approval · 2014-06-11FDA Approved: DOXAZOSIN — Original Application (Accord Healthcare Inc.)
FDA approval of Accord Healthcare Inc.'s original application for generic doxazosin (DOXAZOSIN), an alpha-1 blocker indicated for hypertensi…
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FDA approval · 2014-04-21FDA Approved: UROXATRAL — Supplemental Application (Advanz Pharma (US) Corp.)
FDA approves a supplemental application for UROXATRAL (alfuzosin HCl) from Advanz Pharma US Corp. The approval relates to updates to the pro…
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FDA approval · 2014-02-26FDA Approved: DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE — Original Application (Endo USA, Inc.)
FDA approved Endo USA, Inc.'s dutasteride and tamsulosin hydrochloride combination as an original generic application. The product is indica…
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FDA approval · 2013-11-06FDA Approved: DOXAZOSIN — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for doxazosin by Mylan Pharmaceuticals Inc., indicating approval of the supplemental request.
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FDA approval · 2013-11-05FDA Approved: FINASTERIDE — Original Application (Accord Healthcare, Inc.)
FDA approved Accord Healthcare, Inc.'s FINASTERIDE as an Original Application (ANDA), authorizing the marketing of a generic FINASTERIDE pro…
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FDA approval · 2013-11-05FDA Approved: FINASTERIDE — Original Application (Aurobindo Pharma Limited)
FDA approved the original application for finasteride from Aurobindo Pharma Limited, authorizing a generic version of finasteride for US mar…
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FDA approval · 2013-09-10FDA Approved: AVODART — Supplemental Application (Waylis Therapeutics LLC)
FDA approved a supplemental application for AVODART (dutasteride) submitted by Waylis Therapeutics LLC.