| Elacestrant Dihydrochloride |
Tablet |
II (Paddle) |
75 |
0.01 N HCl |
500 for 100 mg; 1000 for 400 mg |
5, 10, 15, 30, 45 and 60 |
2024/05/31 |
| Elafibranor |
Tablet |
II (Paddle) |
50 |
0.1% sodium dodecyl sulfate (SDS) in phosphate buffer, pH 6.8 |
900 |
10, 15, 20, 30, 45 and 60 |
2026/01/28 |
| Elagolix Sodium |
Tablet |
II (Paddle) |
50 |
0.05 M Sodium Phosphate, pH 6.8 |
900 |
5, 10, 15, 20, 30 and 45 |
2021/04/22 |
| Elagolix Sodium, Estradiol, Norethindrone Acetate; Elagolix Sodium |
Capsule |
Elagolix: I (Basket) |
Elagolix: 100 |
Elagolix: 0.05M Sodium Phosphate pH 6.8 |
|
10, 15, 20, 25, 30, 45, 60 and 90 |
2024/02/05 |
| Elbasvir/Grazoprevir |
Tablet |
I (Basket) |
100 |
Phosphate Buffer, pH 6.8 with 0.45% (w/v) Polysorbate 80 |
900 |
10, 15, 20, 30, 45 and 60 |
2016/07/28 |
| Eletriptan Hydrobromide |
Tablet |
I (Basket) |
100 |
0.1 N HCl |
900 |
5, 10, 15 and 30 |
2009/04/02 |
| Elexacaftor (Ele); Ivacaftor (Iva); Tezacaftor (Tez) |
GRANULES |
II (Paddle) |
65 |
Ele: 1.8% (v/v) Tween 20 in 50 mM sodium phosphate, pH 6.8 Tez: 0.1% (w/v) SLS in 0.1 N HCl Iva: 0.4% (w/v) SLS in 50 mM sodium phosphate buffer, pH 6.8 |
900 |
5, 10, 15, 20, 30, 45, 60 and 75 |
2026/01/28 |
| Elexacaftor, Ivacaftor, Tezacaftor [FDC:ELE+ IVA+ TEZ]; Ivacaftor [IVA] |
Tablet/Tablet (Copackage) |
II (Paddle) |
FDC: ELE: 75/IVA: 65/TEZ:75; IVA: 75 |
FDA: ELE: 1.8% (v/v) Polysorbate 20 in 50 mM sodium phosphate, pH 6.8/ IVA: 0.4% (w/v) SLS in 50 mM sodium phosphate, pH 6.8/TEZ: 0.2% (w/v) SLS solution in 0.1N HCl; IVA: 1.8% (v/v) Polysorbate 20 in 50 mM sodium phosphate, pH 6.8 |
FDC: ELE: 900/IVA: 900/TEZ:900; IVA 900 |
5, 10, 15, 20 and 30 |
2021/08/19 |
| Eliglustat Tartrate |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Eltrombopag Choline |
Tablet |
II (Paddle) |
75 |
0.25% Tween 80 in 0.05 M pH 6.8 Potassium Phosphate Buffer, pH 6.8 |
900 |
5, 10, 15, 20, 30, 45 and 60 |
2026/01/28 |
| Eltrombopag Olamine |
Tablet |
II (Paddle) |
50 |
0.5% Polysorbate 80 in Phosphate Buffer, pH 6.8 |
900 |
10, 15, 20, 30, 45, and 60 |
2012/06/07 |
| Eltrombopag Olamine |
Suspension |
II (Paddle) |
50 |
50 mM potassium phosphate in water, pH 6.8 with 0.2% polysorbate 80 |
750 |
4, 8, 12, 15 and 20 |
2016/10/20 |
| Eluxadoline |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Elvitegravir |
Tablet |
II (Paddle) with sinker |
75 |
2.0% w/v Polysorbate 80 in 0.01 N HCl
(pH 2.0) at 37 ºC |
700 mL for 85 mg tablets; 1000 mL for 150 mg tablets
1000 mL for 150 mg tablets |
10, 20, 30, 45 and 60 |
2015/12/24 |
| Empagliflozin |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Empagliflozin/ Metformin HCl |
Tablet (Extended Release) |
I (Basket) |
100 |
Phosphate Buffer, pH 6.8 |
900 |
Metformin: 1, 2, 4, 6, 8, 10 and 12 hours: Empagliflozin: 10, 15, 20, 30, 45 and 60 minutes; |
2017/01/19 |
| Empagliflozin/Linagliptin |
Tablet |
II (Paddle) |
50 |
pH 6.8 Phosphate Buffer |
900 |
10, 15, 20, 30 and 45 |
2015/12/24 |
| Empagliflozin/Linagliptin/Metformin HCl |
Tablet (Extended Release) |
I (Basket) |
100 |
Phosphate Buffer, pH 6.8 |
900 |
Metformin: 1, 2, 4, 6, 8, 10 and 12 hours: Empagliflozin and Linagliptin: 10, 15, 20, 30, 45 and 60 minutes |
2020/04/02 |
| Empagliflozin/Metformin HCl |
Tablet |
II (Paddle) |
50 |
Phosphate Buffer, pH 6.8 (degas) |
900 |
5, 10, 15, 20 and 30 |
2016/06/30 |
| Emtricitabine |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |