Acetaminophen/Caffeine/Dihydrocodeine Bitartrate |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
Acetaminophen/Hydrocodone Bitartrate |
Tablet |
|
|
Refer to USP (provide individual unit data). |
|
|
2013/08/15 |
Acetaminophen/Ibuprofen |
Tablet |
II (Paddle) |
50 |
50 mM Phosphate Buffer, pH 7.2 |
900 |
5, 10, 15, 20, and 30 |
2023/02/09 |
Acetaminophen/Oxycodone |
Tablet |
|
|
Refer to USP |
|
|
2008/01/14 |
Acetaminophen/Oxycodone HCl |
Tablet (Extended Release) |
II (Paddle) with sinker |
100 |
0.1 N HCl |
900 |
0.25, 0.5, 1, 2, 4, 6 and 8 hours |
2015/11/19 |
Acetaminophen/Pentazocine HCl |
Tablet |
|
|
Develop a dissolution method |
|
|
2023/09/15 |
Acetaminophen/Tramadol HCl |
Tablet |
II (Paddle) |
50 |
0.1 N HCl |
900 |
5, 10, 15, 20 and 30 |
2006/03/04 |
Acetaminophen; Butalbital |
Capsule |
|
|
Develop a dissolution method |
|
|
2024/02/05 |
Acetazolamide |
Capsule (Extended Release) |
II (Paddle) |
75 |
Acetate Buffer, pH 4.5 with 2.2% Tween 20 |
900 |
1, 2, 5, 7, 9, 12 and 14 hours |
2010/01/15 |
Acetazolomide |
Tablet |
|
|
Develop a dissolution method |
|
|
2024/01/03 |
Acetylcysteine |
Tablet (Effervescent) |
|
|
Develop a dissolution method |
|
|
2016/07/28 |
Acitretin |
Capsule |
|
|
Refer to USP |
|
|
2011/09/22 |
Acrivastine/Pseudoephedrine HCl |
Capsule |
II (Paddle) |
50 |
0.01 N HCl |
900 |
5, 10, 15 and 30 |
2004/01/12 |
Acyclovir |
Suspension |
II (Paddle) |
50 |
0.1 N HCl |
900 |
10, 20, 30, 45 and 60 |
2004/02/20 |
Acyclovir |
Tablet |
|
|
Refer to USP |
|
|
2007/06/18 |
Acyclovir |
Capsule |
|
|
Refer to USP |
|
|
2012/01/05 |
Acyclovir |
Tablet (Buccal) |
I (Basket) |
60 |
Phosphate Buffer, pH 6.0 |
1000 |
1, 2, 3, 5, 7, 9 and 12 hours |
2015/08/27 |
Adagrasib |
Tablet |
II (Paddle) |
75 |
pH 6.8 phosphate buffer with 0.3% SLS |
900 |
10, 15, 30, 45 and 60 |
2024/02/05 |
Adefovir Dipivoxil |
Tablet |
|
|
Refer to FDA's Dissolution Guidance, 2018 |
|
|
2020/07/02 |
Afamelanotide |
Implant |
|
|
Develop a method to characterize in vitro release |
|
|
2023/05/18 |