| Dapsone |
Gel (Topical) |
|
|
Develop a method to characterize in vitro release |
|
|
2016/07/28 |
| Daridorexant HCl |
Tablet |
II (Paddle) |
75 |
pH 1.2 (NaCl/HCl) |
900 |
5, 10, 15 and 30 |
2023/05/18 |
| Darifenacin Hydrobromide |
Tablet (Extended Release) |
I (Basket) |
100 |
0.01N HCl |
900 |
1, 4, 8, 12, 16, 20 and 24 hours |
2006/01/20 |
| Darolutamide |
Tablet |
II (Paddle) |
75 |
1% sodium lauryl sulfate (SLS) in 0.01N HCl |
1000 |
15, 30, 45, 60, 75 and 90 |
2020/01/30 |
| Darunavir Ethanolate |
Oral Suspension |
II (Paddle) |
75 |
0.05% Polysorbate 20 in 0.05M Phosphate Buffer, pH 6.8 |
900 |
5, 10, 15, 20, 30 and 45 |
2015/06/25 |
| Darunavir Ethanolate |
Tablet |
II (Paddle) |
75 |
2% Tween-20 in 0.05 M Sodium Phosphate Buffer, pH 3.0 |
900 |
10, 20, 30, and 45 |
2007/09/13 |
| Darunavir(Drv)/Cobicistat (Cobi)/Emtricitabine (Emt)/Tenofovir Alafenamide Fumarate (Taf) |
Tablet |
II (Paddle) |
75 |
Drv: 0.05 M Sodium Phosphate Buffer, pH 3.0, 2% Tween 20; For Cobi, Emt and Taf: Citrate Phosphate Buffer, pH 4.2 |
900 |
Drv: 10, 15, 20, 30 and 45; For Cobi, Emt and Taf: 5, 10, 15, 20 and 30 |
2022/07/07 |
| Dasabuvir Na/ Ombitasvir/Paritaprevir/Ritonavir |
Tablet (Extended Release) |
III (Reciprocating Cylinder [40 mesh (for bottom and top of the inner tube)] |
25 dpm |
15 mM hexadecyltrimethylammonium bromide (CTAB) in 0.03M Sodium Phosphate Buffer, pH 6.8 |
250 |
Ombitasvir/ Paritaprevir/ Ritonavir: 10, 15, 20, 30, 45, 60 and 90 minutes;Dasabuvir: 1, 2, 3, 6, 9, 12, 15, 18, 21 and 24 hours |
2016/10/20 |
| Dasatinib |
Tablet |
II (Paddle) |
60 |
pH 4.0 Acetate buffer containing 1% Triton X-100 |
1000 |
10, 15, 30 and 45 |
2009/10/30 |
| Deferasirox |
Tablet (for Oral Suspension) |
II (Paddle) |
50 |
Phosphate buffer pH 6.8 with 0.5% Tween 20 |
900 |
10, 20, 30 and 45 |
2006/06/21 |
| Deferasirox |
Tablet |
II (Paddle) |
75 |
0.5% Tween 20 in Phosphate Buffer, pH 6.8 |
900 |
5, 10, 15, 20 and 30 |
2016/03/17 |
| Deferasirox |
Granule |
II (Paddle) |
75 |
Phosphate Buffer, pH 6.8 with 0.5% Tween 20 |
900 |
5, 10, 15, 20 and 30 |
2017/11/02 |
| Deferiprone |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Deferiprone (1 GM) |
Tablet |
I (Basket) |
100 |
Acidic Stage: 0.1 N HCl, Buffer Stage: 0.05 M Phosphate buffer, pH 6.8. |
|
Acid Stage: 2 hours; Buffer Stage: 1, 2, 3 and 4 hours |
2022/07/07 |
| Deflazacort |
Suspension |
II (Paddle) |
25 |
Simulated Gastric Fluid, pH 1.2 |
500 |
5, 10, 15 and 30 |
2023/07/07 |
| Deflazacort |
Tablet |
II (Paddle) |
50 |
50 mM Phosphate buffer w/0.3% SLS, pH 6.8 |
500 |
5, ,15, 30 and 45 |
2023/07/07 |
| Degarelix Acetate |
Powder for Injection |
|
|
Develop a method to characterize in vitro release |
|
|
2023/10/06 |
| Delafloxacin Meglumine |
Tablet |
II (Paddle) |
60 |
0.05 M Phosphate Buffer, pH 7.4 (degassed) |
900 |
5, 10, 15, 20 and 30 |
2017/11/16 |
| Delavirdine Mesylate |
Tablet |
II (Paddle) |
50 |
0.05 M Phosphate Buffer, pH 6.0 containing 0.6% w/v SDS |
900 |
10, 20, 30, 45 and 60 |
2007/12/03 |
| Demeclocycline HCl |
Capsule |
|
|
Develop a dissolution method |
|
|
2024/01/03 |