| Erythromycin |
Tablet (Delayed Release) |
|
|
Refer to USP |
|
|
2013/10/31 |
| Erythromycin Ethylsuccinate |
Suspension |
II (Paddle) |
75 |
Monobasic Sodium Phosphate, pH 6.8 Buffer with 1% SLS
Buffer w/ 1% SLS |
900 |
10, 20, 30, 45 and 60 |
2004/01/27 |
| Erythromycin Ethylsuccinate |
Tablet |
|
|
Refer to USP |
|
|
2021/04/22 |
| Erythromycin Ethylsuccinate |
Oral granule |
|
|
Develop a dissolution method |
|
|
2016/06/30 |
| Erythromycin Ethylsuccinate/Sulfisoxazole Acetyl |
Granules for Oral Suspension |
|
|
Develop a dissolution method |
|
|
2010/09/02 |
| Escitalopram Oxalate |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Escitalopram Oxalate |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Eslicarbazepine Acetate |
Tablet |
II (Paddle) |
100 |
Acetate Buffer, pH 4.5 |
1000 |
5, 10, 15, 20, 30 and 45 |
2015/08/27 |
| Esomeprazole Magnesium |
Capsule (Delayed Release Pellets) |
|
|
Refer to USP |
|
|
2015/08/27 |
| Esomeprazole Magnesium |
Tablet (Orally Disintegrating, Delayed Release) |
II (Paddle) |
Acid stage: 100; Buffer stage: 75 |
Acid stage: 0.1 N HCl; Buffer stage: Phosphate Buffer, pH 6.8 |
Acid stage: 300; Buffer stage: 1000 |
Acid stage: 120; Buffer stage: 5, 10, 20, 30 and 45 |
2021/04/22 |
| Esomeprazole Magnesium |
Tablet (Delayed Release) |
II (Paddle) |
100 |
Acid stage: 0.1 N HCl; Buffer stage: Phosphate Buffer, pH 6.8 |
Acid stage: 300; Buffer stage: 1000 |
Acid stage: 120; Buffer stage: 10, 20, 30, 45 and 60 |
2016/10/20 |
| Esomeprazole Magnesium |
For Oral Suspension (Delayed Release) |
II (Paddle |
100 |
Acid stage: 0.1 N HCl; Buffer stage: Sodium Phosphate Buffer, pH 6.8 |
Acid stage: 300; Buffer stage: 1000 |
Acid stage: 120; Buffer stage: 10, 20, 30, 45 and 60 |
2010/09/02 |
| Estazolam |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Esterified Estrogens |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Estradiol |
Vaginal Ring |
Incubator shaker |
130 |
0.9% Saline |
250 |
1, 9, 16, 17, 18, 19, 45 days |
2007/01/03 |
| Estradiol |
Vaginal Tablet |
I (Basket) |
40 |
Phosphate Buffer, pH 4.75 ± 0.05 |
500 |
1, 2, 3, 5, 8, 10 and 12 hours |
2009/07/21 |
| Estradiol |
Vaginal Insert |
III (Reciprocating Cylinder) |
30 dips/min |
0.1 N HCl with 0.5% SLS |
250 |
30, 60, 90 and 120 |
2024/11/01 |
| Estradiol (0.014 mg/24 hr) |
Film, Transdermal (Extended Release) |
|
|
Develop a method to characterize in vitro release |
|
|
2010/10/28 |
| Estradiol (0.025 mg/24 hr, 0.0375 mg/24 hr, 0.05 mg/24 hr, 0.06 mg/24 hr, 0.075 mg/24 hr and 0.1 mg/24 hr) |
Film, Transdermal (Extended Release) |
|
|
Develop a method to characterize in vitro release |
|
|
2010/10/28 |
| Estradiol (E2); Norethindrone Acetate (NETA); Relugolix (Rel) |
Tablet |
II (Paddle) |
50 |
E2 and NETA: 0.3% sodium dodecyl sulfate Rel: 50 mM citrate buffer, pH 5.5 |
|
10, 15, 20, 30, 45 and 60 |
2026/01/28 |