| Voxelotor |
Tablet, for Suspension | II (Paddle) | 75 | 50 mM phosphate buffer (pH 6.8) with 2% sodium lauryl sulfate (SLS) | 900 | 5, 10, 15, 20 and 30 | 2022-07-28 |
| Voxelotor |
Tablet | II (Paddle) | 75 | 50 mM phosphate buffer (pH 6.8) with 2% sodium lauryl sulfate (SLS) | 900 | 5, 10, 20, 30 and 45 | 2022-07-28 |
| Apalutamide |
Tablet | II (Paddle) | 75 | 0.25% sodium lauryl sulfate (SLS) in 0.05 M Sodium Phosphate Buffer, pH 4.5 | 900 | 5, 10, 15, 20, 30, and 45 | 2022-07-28 |
| Edaravone |
Suspension | II (Paddle) | 75 | pH 4.0 Acetate Buffer | 900 | 5, 10, 15, 20 and 30 | 2022-07-28 |
| Posaconazole |
For Suspension (Delayed Release) | II (Paddle) | 75 | Acid stage: 0.01 N HCl; Buffer stage: pH 6.8 Phosphate buffer with 1.3% Tween 80; | Acid stage: 750 mL; | Acid stage: 120; Buffer stage: 5, 10, 15, 20, 30 and 45 | 2022-07-07 |
| Bupivacaine |
Solution (Extended Release), Infiltration | II (Paddle) | 50 | 0.025 M Sodium Phosphate Buffer with 0.03% Sodium Dodecyl Sulfate (SDS), pH 7.4 | 900 | 1, 2, 4, 8, 12, 16, 24, 36 and 48 hours | 2022-07-07 |
| Bismuth Subsalicylate (BiSub)/Metronidazole (Met)/Tetracycline HCl (Tet) |
BiSub: Tablet (Chewable) /Met:Tablet /Tet: Capsule | II (Paddle) | 50 | BiSub: 0.1 N HCl /Met: Refer to USP /Tet: Refer to FDA's Dissolution Guidance, 2018 | 900 | 5, 10, 15, 20 and 30 | 2022-07-07 |
| Selpercatinib |
Capsule | II (Paddle) | 75 | 0.1N HCl | 900 | 5, 10, 15, 20 and 30 | 2022-07-07 |
| Exenatide Synthetic (2 mg) |
For Suspension, Extended Release | | | Develop a method to characterize in vitro release | | | 2022-07-07 |
| Nifurtimox |
Tablet | II (Paddle) | 100 | Acetate Buffer, pH 4.5 with 1.0 % Sodium Dodecyl Sulfate (SDS) (for 30 mg strength) and 1.5 % SDS (for 120 mg strength) | 900 | 10, 20, 30, 60 and 75 | 2022-07-07 |
| Selumetinib |
Capsule | II (Paddle) with sinker | 75 | Sodium Phosphate Buffer, pH 6.5, with 0.5% Polysorbate 80 | 1000 | 10, 20, 30, 45 and 60 | 2022-07-07 |
| Hydroxyurea |
Tablet | | | Refer to FDA's Dissolution Guidance, 2018 | | | 2022-07-07 |
| Darunavir(Drv)/Cobicistat (Cobi)/Emtricitabine (Emt)/Tenofovir Alafenamide Fumarate (Taf) |
Tablet | II (Paddle) | 75 | Drv: 0.05 M Sodium Phosphate Buffer, pH 3.0, 2% Tween 20; For Cobi, Emt and Taf: Citrate Phosphate Buffer, pH 4.2 | 900 | Drv: 10, 15, 20, 30 and 45; For Cobi, Emt and Taf: 5, 10, 15, 20 and 30 | 2022-07-07 |
| Cabotegravir Sodium |
Tablet | II (Paddle) | 60 | 0.01N HCl with 0.2% cetyltrimethylammonium bromide (CTAB) | 1000 | 5, 10, 15, 20, 25 and 30 | 2022-07-07 |
| Ranolazine |
Granules (Extended Release) | II (Paddle) | 50 | 0.1 N HCl | 900 | 0.5, 1, 2, 3, 4, 6 and 8 hours | 2022-07-07 |
| Cedazuridine/Decitabine |
Tablet | II (Paddle) | 75 | 50 mM phosphate buffer, pH 6.8 | 900 | 5, 10, 15 and 30 | 2022-07-07 |
| Deferiprone (1 GM) |
Tablet | I (Basket) | 100 | Acidic Stage: 0.1 N HCl, Buffer Stage: 0.05 M Phosphate buffer, pH 6.8. | | Acid Stage: 2 hours; Buffer Stage: 1, 2, 3 and 4 hours | 2022-07-07 |
| Relugolix |
Tablet | II (Paddle) | 50 | 50 mM Citrate Buffer, pH 5.5 | 900 | 5, 10, 15, 20 and 30 | 2022-07-07 |
| Chlorhexidine Gluconate |
Tablet (Dental) | | | Develop a method to characterize in vitro release | | | 2022-07-07 |
| Exenatide Synthetic (2 mg/0.85 mL) |
Suspension, Extended Release | | | Develop a method to characterize in vitro release | | | 2022-07-07 |
