| Topiramate |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| 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 [40 mg] |
Tablet |
II (Paddle) |
75 |
0.1 N HCl |
900 |
1, 2, 3, 4, 6, 8, 10 and 12 hours |
2022/07/07 |
| Torsemide [5 mg, 10 mg, 20 mg and 100 mg] |
Tablet |
II (Paddle) |
50 |
0.1 N HCl |
900 |
5, 10, 15 and 30 |
2004/02/20 |
| Tovorafenib |
Tablet |
II (Paddle) |
65 |
0.1 N HCl with 0.25% SDS |
900 |
5, 10, 15, 20, 30, 45 and 60 |
2026/01/28 |
| Tovorafenib |
For suspension |
II (Paddle) |
50 |
0.1 N HCl with 0.3% SDS |
900 |
5, 10, 15, 20, 30, 45 and 60 |
2026/01/28 |
| 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 |
| Travoprost |
Implant |
|
|
Develop a method to characterize in vitro release |
|
|
2026/01/28 |
| Trazodone HCl |
Tablet |
|
|
Refer to USP |
|
|
2023/05/18 |
| Trazodone HCl |
Tablet (Extended Release) |
|
|
Develop a dissolution method |
|
|
2023/09/15 |