FDA Approval Activities for this Drug…

Androderm (testosterone transdermal system), Watson, NDA 20-489/S-010 8/9/02 8/12/02 Androderm (testosterone transdermal system), Theratech, NDA 20-489/S-007 1/15/02 2/7/02 AndroGel (testosterone gel), Unimed NDA 21-015/S10 9/26/03 9/30/03 AndroGel (testosterone gel), Unimed NDA 21-015/S8 9/17/03 9/29/03 AndroGel (testosterone gel), Unimed NDA 21-015/S4 10/22/02 10/28/02 10/25/02 AndroGel (testosterone gel). , Unimed NDA 21-015 Striant (testosterone buccal system) mucoadhesive, Columbia , NDA 21-543 Testim 1% (testosterone gel), 50 mg and 100 mg Auxilium NDA 21-454 Striant (testosterone buccal system) mucoadhesive, Columbia , TESTOSTERONE Film, Extended Release; Transdermal 4MG/24HR TESTODERM ALZA 020791 BX TESTOSTERONE Film, Extended Release; Transdermal 5MG/24HR TESTODERM TTS ALZA 019762 TESTOSTERONE Film, Extended Release; Transdermal 6MG/24HR TESTODERM ALZA 020489 TESTOSTERONE Film, Extended Release; Transdermal 2.5MG/24HR ANDRODERM Watson 020489 BX TESTOSTERONE Film, Extended Release; Transdermal 5MG/24HR ANDRODERM Watson 021454 BX TESTOSTERONE Gel; Topical 1% TESTIM AUXILIUM A2 021015 BX TESTOSTERONE Gel; Topical 1% ANDROGEL UNIMED 086417 TESTOSTERONE Injection 100MG/ML TESTOSTERONE STERIS 080911 TESTOSTERONE Pellet; Implantation 75MG TESTOSTERONE BARTOR 021543 TESTOSTERONE Tablet, Extended Release; Buccal 30MG STRIANT COLUMBIA 085635 AO TESTOSTERONE CYPIONATE Injection 100MG/ML DEPO-TESTOSTERONE PHARMACIA AND UPJOHN 085635 AO TESTOSTERONE CYPIONATE Injection 200MG/ML DEPO-TESTOSTERONE PHARMACIA AND UPJOHN 086029 AO TESTOSTERONE CYPIONATE Injection 100MG/ML TESTOSTERONE CYPIONATE STERIS | 086030 AO TESTOSTERONE CYPIONATE Injection 200MG/ML TESTOSTERONE CYPIONATE STERIS | 009165 AO TESTOSTERONE ENANTHATE Injection 200MG/ML DELATESTRYL BTG | 085598 AO TESTOSTERONE ENANTHATE Injection 200MG/ML TESTOSTERONE ENANTHATE STERIS | 080188 TESTOSTERONE PROPIONATE Injection 100MG/ML TESTOSTERONE PROPIONATE STERIS | 080188 TESTOSTERONE PROPIONATE Injection 25MG/ML TESTOSTERONE PROPIONATE STERIS | 080188 TESTOSTERONE PROPIONATE Injection 50MG/ML TESTOSTERONE PROPIONATE STERIS | Testosterone Gel, Paddock Labs, Tentative Approval | Striant (testosterone buccal system) mucoadhesive, Columbia Lab, Control Supplement | Testosterone Cypionate Injection, PharmaForce, Approval

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