Topiramate [25, 50, 100, 150 mg and 200 mg] |
Capsule (Extended Release) |
I (Basket) |
100 |
50 mM Tris buffer, pH 7.2 |
900 |
0.5, 1, 2, 4, 6 and 8 hours |
2015/06/25 |
Topiramate [25, 50, 100 and 200 mg] |
Capsule (Extended Release) |
II (Paddle) |
50 |
0.05 M Phosphate Buffer, pH 7.5 |
750 |
1, 2, 3, 4, 6 and 8 hours |
2014/08/14 |
Topotecan HCl |
Capsule |
II (Paddle) |
50 |
Acetate Buffer with 0.15% SDS, pH 4.5 |
500 |
5, 10, 20, 30 and 45 |
2009/04/27 |
Toremifene Citrate |
Tablet |
II (Paddle) |
50 |
0.02 N HCl |
1000 |
10, 20, 30 and 45 |
2004/02/20 |
Torsemide |
Tablet |
II (Paddle) |
50 |
0.1 N HCl |
900 |
5, 10, 15 and 30 |
2004/02/20 |
Torsemide [20, 40 and 60 mg] |
Tablet |
II (Paddle) |
75 |
0.1 N HCl |
900 |
1, 2, 3, 4, 6, 8 and 10 hours |
2022/07/07 |
Tramadol |
Capsule (Extended Release) |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
Tramadol HCl |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
Tramadol HCl |
Tablet (Extended Release) |
I (Basket) |
75 |
0.1 N HCl |
900 |
2, 4, 8, 10 and 16 hours |
2007/01/03 |
Trametinib Dimethyl Sulfoxide |
Tablet |
II (Paddle) |
60 |
pH 4.5, 50 mM Sodium Acetate with 0.75% Sodium Lauryl Sulfate [SLS] |
500 |
5, 10, 15, 20 and 30 |
2015/12/24 |
Trandolapril |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
Trandolapril/Verapamil HCl |
Tablet (Extended Release) |
II (Paddle) |
50 |
Trandolapril: Develop a dissolution method; Verapamil: 0-1 hour Gastric Fluid w/o Pepsin pH=1.2, 1-8 hour Intestinal Fluid w/o Pancreatin |
Verapamil: 900 |
Verapamil: 1, 2, 3.5, 5 and 8 hours |
2023/09/15 |
Tranexamic Acid |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
Tranylcypromine Sulfate |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
Trazodone HCl |
Tablet (Extended Release) |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
Trazodone HCl |
Tablet |
|
|
Refer to USP |
|
|
2023/05/18 |
Treprostinil Diolamine |
Tablet (Extended Release) |
I (Basket) |
100 |
0.05 M Phosphate Buffer, pH 6.8 (deaerated) |
500 |
1, 2, 4, 6, 8, 12, 16, 20 and 24 hours |
2016/06/02 |
Tretinoin |
Capsule |
I (Basket) |
100 |
0.5% solid Lauryldimethylamine-oxide (LDAO) in 0.05M Phosphate Buffer, pH 7.8 |
900 |
10, 15, 20, 30 and 45 |
2010/08/05 |
Triamcinolone Acetonide |
Injectable Suspension |
|
|
Develop a dissolution method using USP IV (Flow-Through Cell), and, if applicable, Apparatus II (Paddle) or any other appropriate method, for comparative evaluation by the Agency |
|
|
2010/01/15 |
Triamcinolone Acetonide |
Intra-Articular, For Suspension (Extended Release) |
II (Paddle) |
75 |
0.3% SDS in 10 mM phosphate buffer, pH 7.2 + 0.02% sodium azide @35°C |
1000 |
1, 2, 4, 8, 12, 16, 24, 36, 48, 72, 96 and 120 hours |
2018/02/08 |