| Irbesartan |
Tablet |
|
|
Refer to USP |
|
|
2008/08/11 |
| Isavuconazonium Sulfate |
Capsule |
II (Paddle) with sinker |
75 |
Diluted McIlvaine Buffer [12.5 mM disodium hydrogen phosphate solution +6.25 mM citric acid solution ] + 0.5 % Sodium Lauryl sulfate (SLS) |
900 |
10, 20, 30, 45, 60, 75 and 90 |
2016/03/17 |
| Isocarboxazid |
Tablet |
II (Paddle) |
50 |
0.1 N HCl |
900 |
10, 20, 30, 45 and 60 |
2004/02/04 |
| Isoniazid |
Tablet |
|
|
Refer to USP |
|
|
2008/04/15 |
| Isosorbide Dinitrate |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Isosorbide Dinitrate |
Capsule (Extended Release) |
|
|
Refer to USP |
|
|
2015/06/25 |
| Isosorbide Dinitrate |
Tablet (Extended Release) |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Isosorbide Dinitrate/Hydralazine HCl |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2021/08/19 |
| Isosorbide Mononitrate |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Isosorbide Mononitrate |
Tablet (Extended Release) |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Isotretinoin |
Capsule |
|
|
Refer to USP |
|
|
2021/04/22 |
| Isradipine |
Capsule |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Isradipine |
Tablet (Extended Release) |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Istradefylline |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| Itraconazole |
Capsule |
II (Paddle) |
100 |
SGF without Enzyme |
900 |
10, 20, 30, 45, 60 and 90 |
2004/02/04 |
| Itraconazole |
Tablet |
II (Paddle) |
75 |
0.1 N HCl |
900 |
5, 15, 30, 45, 60, 75 and 90 |
2013/08/15 |
| Ivabradine HCl |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Ivacaftor |
Tablet |
II (Paddle) with sinker |
65 |
50 mM Sodium Phosphate Buffer with 0.7% Sodium Dodecyl Sulfate (SDS), pH 6.8 |
900 |
5, 10, 15, 20 and 30 |
2015/06/25 |
| Ivacaftor/lumacaftor |
Tablet |
Lumacaftor: II (Paddle); Ivacaftor: II (Paddle) |
Lumacaftor:65; Ivacaftor: 65 |
Lumacaftor: 0.5% (w/v) CTAB in 50 mM Sodium Acetate Trihydrate buffer (pH 4.5); Ivacaftor: 0.4% (w/v) SLS in 50 mM Sodium Phosphate buffer (pH 6.8) |
Lumacaftor: 900; Ivacaftor: 900 |
5, 10, 15, 20 and 30 |
2016/03/17 |
| Ivacaftor/Tezacaftor [FDC: IVA+ TEZ]; Ivacaftor [IVA] |
Tablet/Tablet (Copackage) |
II (Paddle) with option to use a sinker |
FDC: IVA: 65/TEZ:75; IVA: 65 |
FDC: IVA: 50 mM Sodium Phosphate Buffer with 0.4% Sodium Dodecyl Sulfate (SDS), pH 6.8/TEZ: 0.2 SDS% in 0.1 N HCl; IVA: 50 mM Sodium Phosphate Buffer with 0.7% SDS, pH 6.8; |
FDC: IVA: 900/ TEZ: 900; IVA: 900 |
5, 10, 15, 20, 30 and 45 |
2019/03/07 |
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