Content specific to this active ingredient… Drug Information Prescribing and patient information from leading authorities Drug Master Files Type 2 master files on file at the FDA Drug Recalls For prescription drugs containing this active ingredient Exclusivity Patent and market exclusivity data Federal Register FR search results for this API FDA Approved Labelling Information found in this drug's package inserts Research Links Chemical identification and research citations Title 21 Code of Federal Regulations FDA regulations for this API

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 | AndroGel (testosterone gel), Solvay Pharma, Efficacy Supplement w/Clinical Data | AndroGel (testosterone gel), Solvay Pharma, Labeling Revision | Testosterone Gel, Watson Labs, Approval | Androderm (testosterone transdermal system), Watson Labs, Labeling Revision | Testosterone Enanthate Injection, Paddock Labs, Approval | Testosterone Cypionate Injection, Sandoz, Approval | Testosterone Cypionate Injection, Synerx Pharma, Approval | Delatestryl (testosterone enanthate) Injection, Indevus Pharma, Labeling Revision | Testosterone Gel Packets, Par Pharma, Approval | Delatestryl (testosterone enanthate) Injection, Indevus Inc., Labeling Revision | AndroGel (testosterone) Gel, Solvay Pharma, Labeling Revision | AndroGel (testosterone gel), Solvay Pharma, Labeling Revision ^ FDA's latest approval appears at the bottom of this list. ^   A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U-Z Health Topics | News Feed for each API | DMF Index | Pharma Job Search | Pharma Company News © 2008 Betterchem.com