| Indomethacin |
Rectal Suppository | | | Refer to USP | | | 2021-08-26 |
| Bempedoic Acid |
Tablet | II (Paddle) | 50 | 0.05 M Phosphate buffer, pH 6.6 | 900 | 5, 10, 15, 20 and 30 | 2021-08-19 |
| Entrectinib |
Capsule | II (Paddle) with Sinker | 75 | 50 mM Potassium Phosphate, pH 6.0 with 0.374% w/v polysorbate 80 | 1000 | 15, 20, 30, 45, 60 and 75 | 2021-08-19 |
| Fedratinib HCl |
Capsule | I (Basket) | 50 | 0.1 N HCl | 900 | 5, 10, 15, 20 and 30 | 2021-08-19 |
| Bempedoic Acid/Ezetimibe |
Tablet | II (Paddle) | 50 | Bempedoic Acid: 0.05 M Phosphate buffer, pH 6.6; Ezetimibe: 0.05M Sodium Acetate Buffer pH 4.5 with 0.45% SLS | 900 | 5, 10, 15, 20, 30, and 45 | 2021-08-19 |
| Palbociclib |
Tablet | II (Paddle) | 75 | 0.1 N HCl | 900 | 10, 15, 20, 30 and 45 | 2021-08-19 |
| Apomorphine HCl |
Film (Sublingual) | V (paddle over disk) | 75 | 20mM BIS-TRIS HCl Buffer, pH 6.4 | 500 | 2.5, 5, 7.5, 10, 12.5, 15 and 20 | 2021-08-19 |
| Osilodrostat Phosphate |
Tablet | | | Refer to FDA's Dissolution Guidance, 2018 | | | 2021-08-19 |
| Isosorbide Dinitrate/Hydralazine HCl |
Tablet | | | Refer to FDA's Dissolution Guidance, 2018 | | | 2021-08-19 |
| Ledipasvir/Sofosbuvir |
Pellets | II (Paddle) | 75 | 1.0% polysorbate 80 in 25 mM Potassium Phosphate Buffer, with 0.005 mg/mL Butylated Hydroxytoluene (BHT), pH 5.5 | 900 | 5, 10, 15, 20, 30, 45 and 60 | 2021-08-19 |
| Efavirenz/Lamivudine/Tenofovir Disoproxil Fumarate |
Tablet | II (Paddle) | 75 | 2% SLS in Water | 1000 | 5, 10, 15, 20 and 30 | 2021-08-19 |
| Guanfacine HCl |
Tablet | | | Refer to FDA's Dissolution Guidance, 2018 | 500 | | 2021-08-19 |
| Amifampridine |
Tablet | | | Refer to FDA's Dissolution Guidance, 2018 | | | 2021-08-19 |
| Penicillin G Benzathine |
Injectable | | | Develop a method to characterize in vitro release | | | 2021-08-19 |
| Elexacaftor, Ivacaftor, Tezacaftor [FDC:ELE+ IVA+ TEZ]; Ivacaftor [IVA] |
Tablet/Tablet (Copackage) | II (Paddle) | FDC: ELE: 75/IVA: 65/TEZ:75; IVA: 75 | FDA: ELE: 1.8% (v/v) Polysorbate 20 in 50 mM sodium phosphate, pH 6.8/ IVA: 0.4% (w/v) SLS in 50 mM sodium phosphate, pH 6.8/TEZ: 0.2% (w/v) SLS solution in 0.1N HCl; IVA: 1.8% (v/v) Polysorbate 20 in 50 mM sodium phosphate, pH 6.8 | FDC: ELE: 900/IVA: 900/TEZ:900; IVA 900 | 5, 10, 15, 20 and 30 | 2021-08-19 |
| Amifampridine Phosphate |
Tablet | | | Refer to FDA's Dissolution Guidance, 2018 | | | 2021-08-19 |
| Selinexor |
Tablet | II (Paddle) | 75 | 10 mM Citric Acid Buffer, pH 4.5 with 0.5% SDS | 900 | 10, 15, 20, 30 and 45 | 2021-08-19 |
| Fostemsavir Tromethamine |
Tablet (Extended Release | I (Basket) | 100 | 0.05 M Phosphate Buffer, pH 6.8 buffer, pH 6.8 | 1000 | 1, 2, 3, 5, 7, 10, 12, 16, 20 and 24 hours | 2021-08-19 |
| Semaglutide |
Tablet | II (Paddle) | 70 | 50 mM Phosphate Buffer with 0.05% Brij 35 (polyoxyethylene lauryl ether), pH 6.8 | 500 | 10, 15, 20, 30, 45, 60 and 75 | 2021-08-19 |
| Istradefylline |
Tablet | II (Paddle) with Sinker | 50 | 0.5% sodium lauryl sulfate (SLS) in Water (degas) | 900 | 5, 10, 15, 20 and 30 | 2021-08-19 |
