| Demeclocycline HCl |
Tablet |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Desipramine HCl |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Desloratadine |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Desloratadine |
Tablet (Orally Disintegrating) |
II (Paddle) |
50 |
0.1 N HCl |
900 |
3, 6, 10, 15 |
2007/06/18 |
| Desloratadine/Pseudoephedrine Sulfate (2.5 mg/120 mg) |
Tablet (Extended Release) |
II (Paddle) |
50 |
First hour: 0.1 N HCl; After 1 hour: 0.1M Potassium Phosphate Buffer pH 7.5 |
1000 |
For Desloratadine: 10, 20, 30 and 45; For Pseudoephedrine Sulfate: 1, 2, 6 and 8 hours |
2009/04/02 |
| Desloratadine/Pseudoephedrine Sulfate (5 mg/240 mg) |
Tablet (Extended Release) |
II (Paddle) |
50 |
First hour: 0.1 N HCl; After 1 hour: 0.1M Potassium Phosphate Buffer pH 7.5 |
1000 |
For Desloratadine: 10, 20, 30 and 45; For Pseudoephedrine Sulfate: 1, 2, 4, 8, 16 and 24 hours |
2009/04/02 |
| Desmopressin Acetate |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Desogestrel/Ethinyl Estradiol |
Tablet |
|
|
Refer to USP |
|
|
2008/11/04 |
| Desvenlafaxine Succinate |
Tablet (Extended Release) |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Deucravacitinib |
Tablet |
II (Paddle) |
75 |
50 mM potassium phosphate buffer, pH 6.3 with 0.01% (w/v) Brij®35 |
1000 |
10, 20, 30, 45 and 60 |
2023/11/30 |
| Deuruxoutinib Phosphate |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2026/01/28 |
| Deutetrabenazine |
Tablet, Extended Release |
II (Paddle) with sinker |
75 |
50 mM Potassium Biphthalate pH 3.0 |
500 |
1, 2, 4, 6, 8, 10, 12, 16 and 20 hours |
2025/06/23 |
| Deutetrabenazine |
Tablet |
II (Paddle) over a disk (62 mm with 16 mesh) |
75 |
pH 3.0 Acid Phthalate Buffer |
500 |
0.5, 1, 1.5, 2, 3, 4, 5 and 6 hours |
2017/11/02 |
| Deutivacaftor (Deu); Tezacaftor (Tez); Vanzacaftor Calcium (Van) |
Tablet |
II (Paddle) |
75 |
Van and Deu: 0.5% (w/v) SLS in 50 mM sodium phosphate, pH 6.8; Tez: 0.2% (w/v) SLS solution in 0.1 N HCl |
900 |
5, 10, 15, 20, 30, 45, 60 and 75 |
2026/01/28 |
| Dexamethasone |
Insert |
|
|
Develop a method to characterize in vitro release |
|
|
2026/03/25 |
| Dexamethasone |
Implant (Intravitreal) |
VII (with reciprocating 50 mesh baskets) |
30 cycles per min |
Phosphate Buffered Saline containing 0.05 g/L sodium dodecyl sulfate at 45 ± 0.5°C |
30 |
12, 24, 48, 72, 96, 120, 144, 168, 192, 216 and 240 hours |
2010/10/21 |
| Dexamethasone |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Dexamethasone/Neomycin Sulfate/ Polymyxin B Sulfate |
Ophthalmic Suspension |
|
|
Develop a method to characterize in vitro release |
|
|
2018/02/15 |
| Dexamethasone/Tobramycin |
Ophthalmic Suspension |
|
|
Develop a method to characterize in vitro release |
|
|
2009/04/02 |
| Dexbrompheniramine Maleate/Pseudoephedrine Sulfate |
Tablet (Extended Release) |
III (Reciprocating Cylinder) |
12 dpm |
0.02N HCl (2 hours) followed by
0.05M Phosphate Buffer pH 7.5 |
250 |
0.5, 1, 2, 3, 4, 6 and 8 hours |
2015/05/28 |