| Etidronate Disodium |
Tablet |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Etodolac |
Tablet |
|
|
Refer to USP |
|
|
2008/01/14 |
| Etodolac |
Tablet (Extended Release) |
|
|
Refer to USP |
|
|
2010/06/24 |
| Etoposide |
Capsule |
|
|
Refer to USP |
|
|
2010/06/24 |
| Etrasimod Arginine |
Tablet |
II (Paddle) |
75 |
50 mM Phosphate buffer w/0.2% Tween 20, pH 6.8 |
900 |
5, 15, 20, 30 and 45 |
2024/11/15 |
| Etravirine (200 mg) |
Tablet |
II (Paddle) |
70 |
1.0 % Sodium lauryl sulfate (SLS) in 0.01 M HCl in two phases: Phase 1: 1000 mL of degassed 0.01 M HCl for 10 minutes. Phase 2: Add 800 mL of 2.25% SLS in 0.01 M HCl. |
1000 (phase 1): 1800 (phase 2) |
Phase 1: No Sampling. Phase 2: 5, 10, 20, 30, 45, 60 and 90 |
2011/06/30 |
| Etravirine (25 and 100 mg) |
Tablet |
II (Paddle) |
50 |
1.0 % Sodium lauryl sulfate (SLS) in 0.01 M HCl in two phases: Phase 1: 500 mL of degassed 0.01 M HCl for 10 minutes. Phase 2: Add 400 mL of 2.25% SLS in 0.01 M HCl. |
500 (phase 1): 900 (phase 2) |
Phase 1: No Sampling. Phase 2: 5, 10, 20, 30, 45, 60 and 90 |
2014/08/14 |
| Everolimus |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Exemestane |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Exenatide Synthetic (2 mg) |
For Suspension, Extended Release |
|
|
Develop a method to characterize in vitro release |
|
|
2022/07/07 |
| Exenatide Synthetic (2 mg/0.85 mL) |
Suspension, Extended Release |
|
|
Develop a method to characterize in vitro release |
|
|
2022/07/07 |
| Ezetimibe |
Tablet |
II (Paddle) |
50 |
0.45% SLS in 0.05 M Acetate Buffer, pH 4.5 |
500 |
10, 20, 30 and 45 |
2008/01/14 |
| Ezetimibe/Simvastatin |
Tablet |
II (Paddle) |
50 |
0.01 M Sodium Phosphate, pH 7.0/0.5% SDS |
900 |
5, 10, 20 and 30 |
2007/01/03 |
| Ezogabine |
Tablet |
II (Paddle) |
75 |
0.01 N HCl |
1000 |
5, 10, 15, 20 and 30 |
2013/08/15 |
| Famciclovir |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Famotidine |
Tablet (Orally Disintegrating) |
II (Paddle) |
50 |
0.1 M Phosphate Buffer, pH 4.5 |
900 |
2, 5, 10, 15 and 20 |
2008/10/06 |
| Famotidine |
Tablet (Chewable) |
II (Paddle) |
50 |
0.1 M Phosphate Buffer, pH 4.5 |
900 |
10, 20, 30, 45 and 60 |
2004/01/29 |
| Famotidine |
Tablet |
|
|
Refer to USP |
|
|
2023/02/09 |
| Famotidine |
Suspension |
II (Paddle) |
25 and 50 |
0.1 M Phosphate buffer, pH 4.5 |
900 |
10, 15, 30 and 45 |
2008/11/25 |
| Famotidine/Calcium Carbonate/Magnesium Hydroxide |
Tablet (Chewable) |
|
|
Develop a dissolution method |
|
|
2009/12/15 |
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