Amlodipine Besylate/Benazepril HCl |
Capsule |
I (Basket) |
100 |
0.01 N HCl |
500 |
10, 20 , 30, 45, and 60 |
2007/06/20 |
Amlodipine Besylate/Hydrochlorothiazide/Olmesartan Medoxomil |
Tablet |
II (Paddle) |
50 |
Phosphate Buffer, pH 6.8 |
900 |
5, 10, 15, 20, 30 and 45 |
2011/07/21 |
Amlodipine Besylate/Hydrochlorothiazide/Valsartan |
Tablet |
|
|
Refer to USP |
|
|
2016/07/28 |
Amlodipine Besylate/Olmesartan Medoxomil |
Tablet |
II (Paddle) |
50 |
Phosphate Buffer, pH 6.8 |
900 |
10, 20, 30 and 45 |
2008/08/11 |
Amlodipine besylate/Perindopril Arginine |
Tablet |
II (Teflon coated paddle) |
75 |
0.01 N HCL |
1000 |
5, 10, 15, 20 and 30 |
2016/03/17 |
Amlodipine Besylate/Telmisartan |
Tablet |
II (Paddle) |
75 |
Telmisartan: Phosphate Buffer, pH 7.5; Amlodipine: 0.01N HCl, pH 2 |
Telmisartan: 900; Amlodipine: 500 |
Telmisartan: 10, 15, 20, 30 and 45; Amlodipine: 10, 15, 20, 30 and 45 |
2010/08/05 |
Amlodipine Besylate/Valsartan |
Tablet |
|
|
Refer to USP |
|
|
2016/07/28 |
Amoxicillin |
Capsule |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
Amoxicillin |
Tablet (Extended Release) |
II (Paddle) |
100 |
3 Stage dissolution: 50 mM potassium phosphate monobasic buffer at pH 4.0 (0-2 hours), 6.0 (2-4 hours) and 6.8 ( 4 hours and beyond) |
900 |
0.25, 0.5, 1, 2, 2.25, 2.5, 3, 4, 4.25, 4.5, 5 and 6 hours |
2010/10/21 |
Amoxicillin |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
Amoxicillin |
For Oral Suspension |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
Amoxicillin/Clarithromycin/Lansoprazole |
Capsule/Tablet/Capsule (Copackage) |
|
|
Develop a dissolution method for Amoxicillin Capsules, Refer to USP for monographs of Clarithromycin Tablets and Lansoprazole Delayed-Release Capsules |
|
|
2024/01/03 |
Amoxicillin/Clarithromycin/Omeprazole |
Capsule/Tablet/Capsule (Copackage) |
|
|
Develop a dissolution method for Amoxicillin Capsules, Refer to USP for monographs of Clarithromycin Tablets and Omeprazole Delayed-Release Capsules |
|
|
2024/01/03 |
Amoxicillin/Clavulanate Potassium |
Tablet |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
Amoxicillin/Clavulanate Potassium |
Suspension |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
Amoxicillin/Clavulanate Potassium |
Tablet (Chewable) |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
Amoxicillin/Omeprazole Mg./Rifabutin |
Capsule (Delayed Release) |
I (Basket |
100 |
Amoxicillin/Rifabutin: 0.01 N HCl; Omeprazole: 0.1N HCl; Buffer Stage: 0.05M Phosphate buffer, pH 6.8 |
Amoxicillin/Rifabutin:900; Omeprazole: Acid Stage: 900; Buffer Stage:900; |
Amoxicillin/Rifabutin: 5, 10, 15, 20 and 30; Omeprazole: Acid Stage: 120; Buffer Stage: 5, 10, 15, 20 and 30; |
2020/08/27 |
Amoxicillin; Clarithromycin; Vonoprazan Fumarate |
Capsule, Tablet, Tablet |
Clarithromycin and Vonoprazan: II (Paddle) |
Clarithromycin and Vonoprazan: 50 |
Amoxicillin: Develop a dissolution method; Clarithromycin: 0.1M Sodium Acetate Buffer (pH 5.0); Vonoprazan: 0.05M Acetate Buffer (pH 4.5) |
900 |
10, 15, 30, 45, 60 and 90 |
2024/02/05 |
Amoxicillin; Vonoprazan Fumarate |
Capsule, Tablet |
Vonoprazan: II (Paddle) |
Vonoprazan: 50 |
Amoxicillin: Develop a dissolution method; Vonoprazan: 0.05M Acetate Buffer (pH 4.5) |
900 |
10, 15, 30, 45, 60 and 90 |
2024/02/05 |
Amphetamine |
Tablet (Extended Release, Orally Disintegrating) |
II (Paddle |
75 |
Acid Stage: 0.1 N HCl; Buffer Stage: Phosphate Buffer, pH 6.8 |
Acid Stage: 900 mL; Buffer Stage: 1000 mL |
Acid Stage: 10, 15, 30, 45, 60, 90, 120; Buffer Stage: 5, 10, 15, 30 and 45 |
2016/07/28 |