Estradiol/Levonorgestrel |
Film, Transdermal (Extended Release) | V (Paddle over Disk) attach th | 50 | 30% Ethanol in water at 32±0.5°C | 660 | 30, 60, 120, 180, 240 and 300 | 2023-03-30 |
Celecoxib/Tramadol |
Tablet | II (Paddle) | 75 | 0.1 N HCl + 2% SLS | 1000 | 5,10,15, and 20 | 2023-03-30 |
Baricitinib |
Tablet | II (Paddle) | 75 | Acetate buffer pH 4.5 | 900 | 5, 15, 30, 45 | 2023-03-30 |
Progesterone |
Gel | I (Basket) with Diacell sample | 100 | Methanol:water 20:80 | 1000 | 2, 4, 8, 12, 20, 24, 48 and 72 hours | 2023-03-30 |
Omeprazole Magnesium |
Capsule, Delayed Release | II (Paddle) | 100 | Acid stage: 0.1 N HCl (deaerated) for 2 hrs; Buffer stage: Phosphate buffer (deaerated), pH 6.8 | | Acid stage: 120; Buffer stage: 10, 20, 30 and 45 | 2023-03-30 |
Patisiran Sodium |
Solution | II (Paddle) | 25 | Tris/EDTA buffer, pH 7.5 with 0.02% Tween 20 | 500 | 2, 5, 7, 11 and 15 | 2023-03-30 |
Mitapivat Sulfate |
Tablet | II (Paddle) | 70 | 100 mM sodium phosphate, pH 6.8, with 0.05% w/w sodium dodecyl sulfate (SLS) | 900 | 5, 10, 15, 20 and 30 | 2023-03-30 |
Tepotinib HCl |
Tablet | II (Paddle) | 50 | Acetate buffer, pH 4.5 + 1 mM NaCl + 0.1% polysorbate 80 | 900 | 5, 15, 20 and 35 | 2023-03-30 |
Calcium carbonate/Famotidine/ Magnesium hydroxide |
Tablet, Chewable | III (Reciprocating Cylinder) | | 0.1 M Sodium Acetate, pH 4.5 | 900 | 5,10, 15, 20, 30 and 45 | 2023-03-30 |
Estradiol/Norethindrone Acetate |
Film, Transdermal (Extended Release) | V (Paddle over Disk) | 50 | 0.24% SDS in water at 32±0.5°C | 0.05 mg/0.14 mg/24 h | 1, 2, 4, 8, 12 and 14 hours | 2023-03-30 |
Drospirenone/Estetrol |
Tablet | II (Paddle) | 50 | Phosphate Buffer pH 6.8 | 900 | 5,10, 15, 20 and 30 | 2023-03-30 |
Fidaxomicin |
For Oral Suspension | II (Paddle) | 40 | Water with 2% Tween 80 | 900 | 15, 30, 45 and 60 | 2023-02-09 |
Famotidine |
Tablet | | | Refer to USP | | | 2023-02-09 |
Acetaminophen/Ibuprofen |
Tablet | II (Paddle) | 50 | 50 mM Phosphate Buffer, pH 7.2 | 900 | 5, 10, 15, 20, and 30 | 2023-02-09 |
Ibrexafungerp Citrate |
Tablet | II (Paddle) | 50 | 0.1N HCl | 900 | 10, 15, 20, 30 and 45 | 2023-02-09 |
Ketoprofen |
Capsule | II (Paddle with sinker) | 50 | 0.05M Potassium Phosphate Buffer, pH 7.4 | 1000 | 10, 20, and 30 | 2023-02-09 |
Ampicillin/Ampicillin Trihydrate |
Capsule | I (Basket) | 100 | Water | 900 | 10, 15, 20, 30 and 45 | 2023-02-09 |
Lamotrigine |
Tablet, For Suspension | | | Refer to USP | | | 2023-02-09 |
Baloxavir Marboxil |
Tablet | II (Paddle) | 50 | Phosphate Buffer, pH 6.8 containing 0.16% w/v cetyl trimethylammonium bromide (CTAB) | 900 | 10, 15, 20, 30 and 45 | 2023-02-09 |
Berotralstat HCl |
Capsule | | | Refer to FDA's Dissolution Guidance, 2018 | | | 2023-02-09 |