| Indomethacin |
Suspension |
|
|
Refer to USP |
|
|
2024/05/31 |
| Indomethacin |
Capsule (Extended Release) |
|
|
Refer to USP |
|
|
2007/07/25 |
| Indomethacin (40 mg and 20 mg) |
Capsule |
I (Basket) |
100 |
10 mM citric acid buffer, pH 5.75 |
750 |
5, 10, 15, 20 and 30 |
2015/05/28 |
| Indomethacin (50 and 25 mg) |
Capsule |
|
|
Refer to USP |
|
|
2015/05/28 |
| Infigratinib Phosphate |
Capsule |
I (Basket) |
100 |
0.01 N HCl |
900 |
15, 30, 45 and 60 |
2023/05/18 |
| Iptacopan Hydrochloride |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2025/06/23 |
| 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 |
Capsule (Extended Release) |
|
|
Refer to USP |
|
|
2015/06/25 |
| Isosorbide Dinitrate |
Tablet (Extended Release) |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Isosorbide Dinitrate |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
| Isosorbide Dinitrate/Hydralazine HCl |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2021/08/19 |
| Isosorbide Mononitrate |
Tablet (Extended Release) |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
| Isosorbide Mononitrate |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
| 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 |