| 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 |
| 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 |
| Levacetylleucine |
For Suspension |
II (Paddle) |
50 |
0.1 N HCl |
900 |
5, 10, 15, 30 and 45 |
2026/01/28 |
| Levetiracetam |
Tablet, for Suspension |
II (Paddle) |
50 |
Phosphate Buffer, pH 6.8 (degas) |
900 |
2.5, 5, 10, 15 and 20 |
2017/03/02 |
| Levetiracetam |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Levetiracetam (1 g and 1.5 g) |
Tablet (Extended Release) |
III (Reciprocating Cylinder) |
15 dips/min |
Sodium acetate buffer, pH 4.5 |
900 |
1, 2, 4, 6, 8, 10 and 12 hours |
2024/11/01 |
| Levetiracetam (500 mg and 750 mg) |
Tablet (Extended Release) |
I (Basket) |
100 |
0.05 M Phosphate Buffer, pH 6.0 |
900 |
1, 2, 4, 6, 8 and 12 hours |
2009/04/02 |
| Levocarnitine |
Tablet |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Levocetirizine Dihydrochloride |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Levofloxacin |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Levoketoconazole |
Tablet |
II (Paddle) |
50 |
0.05 N HCl |
900 |
10, 20, 30, 45 and 60 |
2025/06/23 |
| Levomilnacipran HCl |
Capsule (Extended Release) |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Levonorgestrel |
Tablet |
II (Paddle) |
75 |
0.1 N HCl with 0.1% SLS |
1000 |
10, 20, 30, 45, 60 and 90 |
2004/02/05 |