| Lamivudine/Zidovudine |
Tablet |
|
|
Refer to USP |
|
|
2017/11/02 |
| Lamivudine/Zidovudine + Efavirenz |
Tablet (Copackage) |
II (Paddle) |
Lamivudine and Zidovudine: 75 |
Lamivudine and Zidovudine: 0.1 N HCl Efavirenz: Develop a dissolution method |
Lamivudine and Zidovudine: 1000 |
10, 20, 30, and 45 |
2023/09/15 |
| Lamivudine/Zidovudine + Nevirapine |
Tablet (Copackage) |
II (Paddle) |
50 |
Lamivudine and Zidovudine: Develop a dissolution method Nevirapine: 0.06 M HCl (pH 1.2) |
900 |
10, 15, 30, 45 and 60 |
2023/09/15 |
| Lamivudine/Zidovudine/ Nevirapine |
Tablet |
II (Paddle) |
50 |
0.01 N HCl |
900 |
10, 15, 30, 45 and 60 |
2007/01/03 |
| Lamotrigine |
Tablet (Chewable dispersible) |
II (Paddle) |
50 |
0.1 N HCl |
900 |
5, 10, 15, 20 and 30 |
2008/01/14 |
| Lamotrigine |
Tablet, For Suspension |
|
|
Refer to USP |
|
|
2023/02/09 |
| Lamotrigine |
Tablet (Regular) |
II (Paddle) |
50 |
0.1 N HCl |
900 |
5, 10, 15, 20 and 30 |
2006/03/04 |
| Lamotrigine |
Tablet (Extended Release) |
|
|
Refer to USP |
|
|
2016/02/18 |
| Lansoprazole |
Capsule (Delayed Release) |
|
|
Refer to USP |
|
|
2008/11/04 |
| Lansoprazole |
Tablet (Delayed Release, Orally Disintegrating) |
II (Paddle) |
75 |
Acid Stage: 0.1 N HCl; Buffer Stage: Phosphate Buffer, pH 6.8 with 5 mM Sodium Dodecyl Sulfate |
500 (Acid), 900 (Buffer) |
60 (Acid), 10, 20, 30 and 45 (Buffer) |
2008/11/04 |
| Lanthanum Carbonate |
Chewable Tablet |
Reciprocating Cylinder (Apparatus 3 modified) |
10 dpm (dip rate per minute) |
0.25 N HCl |
900 (modified from the standard apparatus 3 vessel to achieve sink condition) |
10, 20, 30 and 45 |
2007/01/03 |
| Lapatinib Ditosylate |
Tablet |
II (Paddle) |
55 |
2% Polysorbate 80 in 0.1 N HCl |
900 |
10, 15, 30 and 45 |
2009/10/30 |
| Lasmiditan Succinate |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2022/05/12 |
| 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 |