| Estradiol/Levonorgestrel |
Film, Transdermal (Extended Release) |
V (Paddle over Disk) attach the patch to the stainless steel plate with double-sided tape |
50 |
30% Ethanol in water at 32±0.5°C |
660 |
30, 60, 120, 180, 240 and 300 |
2023/03/30 |
| Estradiol/Norethindrone Acetate |
Film, Transdermal (Extended Release) |
V (Paddle over Disk) |
50 |
0.24% SDS in water at 32±0.5°C |
0.05 mg/0.14 mg/24 hr: 500; 0.05mg/0.25 mg/24 hr: 900 |
1, 2, 4, 8, 12 and 14 hours |
2023/03/30 |
| Estradiol/Norethindrone Acetate |
Tablet |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Estradiol/Norgestimate (1mg/0.09mg) |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Estradiol/Progesterone |
Capsule |
III (Reciprocating Cylinder) [40 mesh for bottom and top of the inner tube] |
|
3% sodium lauryl sulfate (SLS) in 0.1N HCl |
250 |
10, 20, 30, 45 and 60 |
2020/01/30 |
| Estramustine Phosphate Sodium |
Capsule |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Estrogens Conjugated Synthetic A |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Estrogens, Conjugated (EC)/Medroxyprogesterone Acetate (MPA) |
Tablet |
II (Paddle) with sinker |
50 |
EC: 0.02 M Na Acetate Buffer (pH 4.5); MPA: Develop a dissolution method |
900 |
|
2023/09/15 |
| Estrogens, Conjugated Synthetic B |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Eszopiclone |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Ethacrynic Acid |
Tablet |
|
|
Refer to USP |
|
|
2010/12/23 |
| Ethambutol HCl |
Tablet |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Ethinyl Estradiol |
Tablet |
|
|
Refer to USP |
|
|
2011/09/22 |
| Ethinyl Estradiol/Ethynodiol Diacetate |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Ethinyl Estradiol/Etonogestrel |
Vaginal Ring |
|
|
Develop a method to characterize in vitro release |
|
|
2013/01/31 |
| Ethinyl Estradiol/Levonorgestrel |
Transdermal System |
V (paddle over disk) |
75 |
0.25% Hydroxypropyl-Beta-Cyclodextrin (HPCD) in Water (Deaerated ), 32±0.5˚C |
500 |
1, 2, 4, 6, 12, 24, 36, 48, 72 and 96 hours |
2022/05/12 |
| Ethinyl Estradiol/Levonorgestrel |
Tablet |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Ethinyl Estradiol/Norethindrone |
Tablet (Chewable) |
II (Paddle) |
75 |
0.09% Sodium Lauryl Sulfate in 0.1 N HCl |
500 |
10, 15, 20, 30 and 45 |
2008/01/14 |
| Ethinyl Estradiol/Norethindrone |
Tablet |
|
|
Refer to USP |
|
|
2009/07/15 |
| Ethinyl Estradiol/Norethindrone Acetate |
Tablet |
|
|
Refer to USP |
|
|
2009/07/15 |
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