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 |
|
|
Refer to USP |
|
|
2023/05/18 |
Trazodone HCl |
Tablet (Extended Release) |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
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 |
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 |
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 |
Triclabendazole |
Tablet |
II (Paddle) |
75 |
0.1N HCl with 1% Tween 20 |
1000 |
5, 10, 15, 20 and 30 |
2020/08/27 |
Trientine HCl |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
Trimethoprim |
Tablet |
|
|
Refer to USP |
|
|
2010/01/29 |
Trimipramine Maleate |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
Triptorelin Pamoate |
For Intramuscular Suspension (Extended Release) |
II (Paddle) |
75 |
50 mL of methanol to 950 mL of water |
950 |
1, 8, 24, 96, and 168 hours |
2017/11/16 |
Triptorelin Pamoate |
Injectable Suspension |
II (Paddle) |
200 |
Water-Methanol (95:5); Reconstitute vial in 2 mL Water for Injection, add to 500 mL medium at 37°C |
500 |
1, 6, 12, 24, 48 and 72 hours |
2008/07/14 |
Trospium Chloride |
Capsule (Extended Release) |
II (Paddle) with sinker |
50 |
0.1 N HCl, pH 1.1 for 2 hrs and then add 200 mL of 0.1 N NaOH in 200 mM Phosphate Buffer. Adjust pH to 7.5 using 2 N HCl and/or 2N NaOH |
0-2 hrs: 750 ml, After 2 hrs: 950 ml. |
2, 3, 4, 6, 8, 12 and 16 hours |
2010/07/15 |
Trospium Chloride |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
Tucatinib |
Tablet |
II (Paddle) |
75 |
0.1 M Citrate Buffer, pH 3.4, containing 0.05% Brij 35 (polyoxyethylene lauryl ether) |
900 |
10, 15, 20, 30 and 45 |
2022/05/12 |
Ulipristal Acetate |
Tablet |
II (Paddle) |
50 |
0.1 N HCl |
900 |
5, 10, 15, 20 and 30 |
2013/01/31 |
Upadacitinib |
Tablet (Extended Release) |
I (Basket) |
100 |
50 mM Phosphate buffer, pH 6.8 [for 15 mg and 30 mg strengths]; 25 mM Phosphate buffer with 2.75% NaCl, pH 6.8 for [45 mg strength] |
900 |
1, 2, 4, 6, 8, 12 and 16 hours |
2023/02/09 |
Uridine Triacetate |
Granule |
II (Paddle) |
60 |
50 mM
Phosphate
Buffer, pH 6.8 |
900 |
10, 15, 20, 30, 45 and 60 |
2022/07/07 |