| Diltiazem HCl |
Tablet (Extended Release) |
II (Paddle) |
100 |
Phosphate Buffer, pH 5.8 |
900 |
2, 8, 14, and 24 hours |
2008/02/19 |
| Diltiazem HCl |
Capsule (Extended Release) |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Dimethyl Fumarate |
Capsule (Delayed Release) |
II (Paddle) |
100 |
Acid stage: 0.1 N HCl; Buffer stage: pH 6.8 Phosphate Buffer |
Acid stage: 500; Buffer stage: 500 |
Acid stage: 2 hours; Buffer stage: 5, 10, 20, 30 and 45 |
2016/06/02 |
| Dinoprostone |
Vaginal Insert (Extended Release) |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Dinoprostone |
Vaginal Suppository |
|
|
Develop a method to characterize in vitro release |
|
|
2012/10/04 |
| Diphenhydramine Citrate/Ibuprofen |
Tablet |
II (Paddle) |
50 |
50 mM Phosphate Buffer, pH 6.5 |
900 |
10, 20, 30 and 45 |
2008/01/14 |
| Diphenhydramine HCl/Ibuprofen |
Capsule |
I (Basket) |
100 |
200 mM Phosphate Buffer, pH 7.2 |
900 |
10, 20, 30 and 45 |
2008/01/14 |
| Dipyridamole |
Tablet |
|
|
Refer to USP |
|
|
2007/06/18 |
| Diroximel Fumarate |
Capsule (Delayed Release) |
II (Paddle) with sinker |
75 |
Acid Stage: 0.1 N HCl; Buffer Stage: Na.Phosphate Buffer, pH 6.5 |
|
Acid Stage: 120; Buffer Stage: 10, 20, 30, 45, 60, 75 and 90 |
2020/04/02 |
| Disopyramide Phosphate |
Capsule (Extended Release) |
|
|
Refer to USP |
|
|
2008/11/04 |
| Disopyramide Phosphate |
Capsule |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Disulfiram |
Tablet |
II (Paddle) |
100 |
2% SDS |
900 |
15, 30, 45, 60, 75, 90, 105, and 120 |
2007/06/18 |
| Divalproex Sodium |
Tablet (Delayed Release) |
|
|
Refer to USP |
|
|
2007/07/25 |
| Divalproex Sodium |
Tablet (Extended Release) |
|
|
Refer to USP |
|
|
2016/06/30 |
| Divalproex Sodium |
Capsule (Delayed Release) |
|
|
Refer to USP |
|
|
2016/06/30 |
| Dofetilide |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Dolasetron Mesylate |
Tablet |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Dolutegravir Na/Rilpivirine HCl |
Tablet |
II (Paddle) |
75 |
1.0 % Tween 20 in 0.01 M HCl, pH 2.0 |
900 |
10, 15, 20, 30, 45 and 60 |
2018/02/08 |
| Dolutegravir Sodium (10 mg) |
Tablet |
II (Paddle) |
50 |
0.01M pH 6.8 phosphate buffer |
900 |
5, 10, 15, 20, 30 and 45 |
2018/10/18 |
| Dolutegravir Sodium (25 mg) |
Tablet |
II (Paddle) |
50 |
0.01M pH 6.8 phosphate buffer containing 0.15% w/v sodium dodecyl sulfate (SDS) |
900 |
5, 10, 15, 20, 30 and 45 |
2018/10/18 |