Hypogonadism
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Sign up freeTop drugs studied for this disease
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FDA approval · 2014-01-02FDA Approved: TESTIM — Supplemental Application (Endo USA, Inc.)
The FDA has approved a supplemental application for TESTIM (testosterone gel) submitted by Endo USA, Inc. The approval covers changes reques…
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FDA approval · 2013-08-30FDA Approved: TESTIM — Supplemental Application (Endo USA, Inc.)
FDA approved a supplemental application for TESTIM (testosterone) by Endo USA, Inc. The action updates the regulatory status of the testoste…
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FDA approval · 2013-06-03FDA Approved: TESTOSTERONE CYPIONATE — Original Application (Sun Pharmaceutical Industries, Inc.)
FDA approved Sun Pharmaceutical's testosterone cypionate under an Original Application (ANDA201720) for a generic testosterone replacement t…
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FDA approval · 2013-05-20FDA Approved: TESTOSTERONE — Supplemental Application (Prasco Laboratories)
The FDA approved a supplemental application for TESTOSTERONE (Prasco Laboratories). This action updates the product labeling.
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FDA approval · 2013-05-20FDA Approved: ANDROGEL — Supplemental Application (ASCEND Therapeutics U.S., LLC)
FDA approved a supplemental application for ANDROGEL (testosterone gel) submitted by ASCEND Therapeutics U.S., LLC. The action updates the p…
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FDA approval · 2013-04-04FDA Approved: GONAL-F RFF REDI-JECT — Supplemental Application (EMD Serono, Inc.)
FDA approved a supplemental application for GONAL-F RFF REDI-JECT (follitropin) related to its REDI-JECT delivery system, expanding the appr…
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FDA approval · 2013-03-13FDA Approved: TESTOSTERONE — Supplemental Application (Prasco Laboratories)
FDA approved a supplemental application for TESTOSTERONE by Prasco Laboratories.
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FDA approval · 2013-03-12FDA Approved: TESTOSTERONE — Supplemental Application (Prasco Laboratories)
FDA granted supplemental approval for TESTOSTERONE by Prasco Laboratories, enabling updated labeling for the testosterone product.
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FDA approval · 2013-02-19FDA Approved: GONAL-F RFF REDI-JECT — Supplemental Application (EMD Serono, Inc.)
FDA approved a supplemental application for GONAL-F RFF REDI-JECT (follitropin) by EMD Serono, Inc., adding the REDI-JECT delivery system to…
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FDA approval · 2013-02-19FDA Approved: GONAL-F — Supplemental Application (EMD Serono, Inc.)
FDA approved a supplemental application for GONAL-F (follitropin alfa) submitted by EMD Serono, Inc., resulting in an approved update to the…
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FDA approval · 2013-02-14FDA Approved: GONAL-F — Supplemental Application (EMD Serono, Inc.)
FDA approved a supplemental application for GONAL-F (follicle-stimulating alfa) submitted by EMD Serono, Inc.
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FDA approval · 2012-11-19FDA Approved: ANDROGEL — Supplemental Application (ASCEND Therapeutics U.S., LLC)
The FDA approved a supplemental application for ANDROGEL (testosterone gel) from ASCEND Therapeutics U.S., LLC.
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FDA approval · 2012-11-19FDA Approved: TESTOSTERONE — Supplemental Application (Prasco Laboratories)
The FDA approved a supplemental application for TESTOSTERONE, submitted by Prasco Laboratories.
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FDA approval · 2012-09-20FDA Approved: ANDROGEL — Supplemental Application (ASCEND Therapeutics U.S., LLC)
The FDA approved a supplemental application for ANDROGEL (testosterone) submitted by ASCEND Therapeutics U.S., LLC.
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FDA approval · 2012-09-18FDA Approved: TESTOSTERONE ENANTHATE — Original Application (Hikma Pharmaceuticals USA Inc.)
FDA approved the original ANDA for testosterone enanthate (TESTOSTERONE ENANTHATE) from Hikma Pharmaceuticals USA Inc. as a generic testoste…
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FDA approval · 2012-09-07FDA Approved: TESTOSTERONE — Supplemental Application (Prasco Laboratories)
FDA approved a supplemental application from Prasco Laboratories for a testosterone product, enabling its marketing as a generic testosteron…
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FDA approval · 2012-05-01FDA Approved: TESTOSTERONE CYPIONATE — Original Application (Padagis US LLC)
FDA approved Padagis US LLC's original Abbreviated New Drug Application (ANDA) for testosterone cypionate, providing a generic option for te…
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FDA approval · 2011-11-22FDA Approved: TESTIM — Supplemental Application (Endo USA, Inc.)
The FDA approved a supplemental application for TESTIM (testosterone) from Endo USA, Inc., resulting in an approved change to the product's …
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FDA approval · 2011-10-28FDA Approved: CONJUGATED ESTROGENS — Supplemental Application (Prasco Laboratories)
FDA has approved a supplemental NDA for Conjugated Estrogens (Estrogens, Conjugated) from Prasco Laboratories.
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FDA approval · 2011-04-29FDA Approved: TESTOSTERONE — Original Application (Prasco Laboratories)
FDA approved an original application for testosterone (TESTOSTERONE) by Prasco Laboratories.
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FDA approval · 2011-04-15FDA Approved: NOVAREL — Supplemental Application (Ferring Pharmaceuticals Inc.)
FDA approved a supplemental application for NOVAREL (chorionic gonadotropin) from Ferring Pharmaceuticals. This action involves changes to l…
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FDA approval · 2011-04-15FDA Approved: CHORIONIC GONADOTROPIN — Supplemental Application (Fresenius Kabi USA, LLC)
FDA approved a supplemental application for chorionic gonadotropin (Chorionic Gonadotropin) by Fresenius Kabi USA, LLC.
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FDA approval · 2011-03-10FDA Approved: ANDROGEL — Supplemental Application (ASCEND Therapeutics U.S., LLC)
FDA approved a supplemental application for ANDROGEL (testosterone) from ASCEND Therapeutics U.S., LLC.
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FDA approval · 2010-01-19FDA Approved: ESTRADIOL VALERATE — Original Application (American Regent, Inc.)
FDA approved Estradiol Valerate under an Original Application (ANDA 090920), granting a new generic product status to American Regent, Inc.
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FDA approval · 2009-09-18FDA Approved: ANDROGEL — Supplemental Application (ASCEND Therapeutics U.S., LLC)
FDA approved a supplemental application for AndroGel (testosterone) from ASCEND Therapeutics U.S., LLC.