| Lazertinib Mesylate |
Tablet |
II (Paddle) |
75 |
1.0% Polysorbate 20 in 0.1 M Sodium Citrate Buffer (80 mg strength), pH 4.5; 2.0% Polysorbate 20 in 0.1 M Sodium Citrate Buffer, pH 4.5 (240 mg strength) |
900 |
5, 10, 15, 20, 30, 45 and 60 |
2026/01/28 |
| Ledipasvir/Sofosbuvir |
Tablet |
II (Paddle) |
75 |
1.5% Polysorbate 80 in 10 mM Potassium Phosphate Buffer with 0.0075 mg/mL Butylated Hydroxytoluene (BHT), pH 6.0 |
900 |
5, 10, 15, 20, 30, 45 and 60 |
2015/08/27 |
| Ledipasvir/Sofosbuvir |
Pellets |
II (Paddle) |
75 |
1.0% polysorbate 80 in 25 mM Potassium Phosphate Buffer, with 0.005 mg/mL Butylated Hydroxytoluene (BHT), pH 5.5 |
900 |
5, 10, 15, 20, 30, 45 and 60 |
2021/08/19 |
| Lefamulin Acetate |
Tablet |
II (Paddle) |
50 |
0.1 N HCl |
1000 |
10, 20, 30, 45, 60, 75, and 90 |
2021/04/22 |
| Leflunomide |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Leflunomide (100 mg) |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Lemborexant |
Tablet |
II (Paddle) |
50 |
0.1 N HCl |
900 |
5, 10, 15, 20 and 30 |
2022/05/12 |
| Lenacapavir Sodium |
Tablet |
II (Paddle) with sinkers |
75 |
30 mM potassium phosphate, pH 6.0 with 2.0% Cremophor EL |
900 |
10, 15, 20, 25, 30, 45 and 60 |
2024/02/05 |
| Lenalidomide |
Capsule |
II (Paddle) |
50 |
0.01 N HCl |
900 |
10, 15, 20, 30 and 45 |
2008/04/15 |
| Leniolisib Phosphate |
Tablet |
I (Basket) |
100 |
Acetate Buffer, pH 4.0 |
900 |
10, 20, 30, 40, 50, 60, 70 and 80 |
2024/08/05 |
| Lenvatinib Mesylate |
Capsule |
II (Paddle) |
50 |
0.1 N HCl |
900 |
5, 10, 15, 20 and 30 |
2016/03/17 |
| Lesinurad |
Tablet |
II (Paddle) |
75 |
pH 4.5 sodium acetate buffer with 1% SLS |
900 |
10, 20, 30 and 45 |
2016/03/17 |
| Letermovir |
Tablet |
II (Paddle) |
75 |
25 mM Na Acetate Buffer, pH 4.5 with 0.6% Tween-80 |
900 |
10, 15, 20, 30, 45 and 60 |
2018/02/08 |
| Letermovir |
Pellets |
II (Paddle) |
75 |
25 mM sodium acetate buffer, pH 4.5 with 0.6% Tween-80 |
900 |
5, 10, 15, 20, 30, 45 and 60 |
2026/03/25 |
| Letrozole |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Letrozole (LET); Ribociclib Succinate (RIB) |
Tablet/Tablet (Copackage) |
II (Paddle) |
RIB: 50; LET: 75 |
RIB: 0.01 N HCl; LET: 0.1 N HCl |
RIB: 900; LET: 900 |
5, 10, 15, 20, 30 and 45 |
2019/03/07 |
| Leucovorin Calcium |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Leuprolide Acetate |
Implant |
|
|
Develop a method to characterize in vitro releas |
|
|
2022/05/12 |
| Leuprolide Acetate |
Injectable (Extended Release) |
|
|
Develop a dissolution method using USP IV (Flow-Through Cell), and, if applicable, Apparatus II (Paddle) or any other appropriate method, for comparative evaluation by the Agency |
|
|
2010/01/15 |
| Leuprolide Mesylate |
Emulsion |
|
|
Develop a method to characterize in vitro release |
|
|
2023/10/06 |