Ivosidenib |
Tablet | II (Paddle) | 50 | 50 mM Phosphate Buffer pH, 6.8 with 0.6% sodium dodecyl sulfate (SDS), | 900 | 10, 15, 20, 30 and 45 | 2020-08-27 |
Cysteamine Bitartrate |
Granule (Delayed Release) | I (Basket | 75 rpm (for 75 mg strength); 150 rpm (for 300 mg strength) | Acid Stage: 0.1 N HCl; Buffer Stage: 0.2M Sodium Phosphate buffer, pH 6.8 | | Acid Stage: 120; Buffer Stage: 5, 10, 15, 20 and 30 | 2020-08-27 |
Tafenoquine Succinate |
Tablet | II (Paddle) | 75 | 0.01M Sodium phosphate buffer, pH 6.8, with 0.20% w/v of Polysorbate 20 | 900 | 5, 10, 20, 30, 45 and 60 | 2020-08-27 |
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: 5, 10, 15, 20 and 30; Omeprazole: Acid Stage: 120; Buffer Stage: 5, 10, 15, 20 and 30; | 2020-08-27 |
Talazoparib Tosylate |
Capsule | II (Paddle) with sinker | 75 | 0.01 N HCl with 0.2% sodium dodecyl sulfate (SDS), | 500 | 10, 15, 20, 30 and 45 | 2020-08-27 |
Prucalopride Succinate |
Tablet | II (Paddle) | 50 | 0.1 N HCl | 900 | 5, 10, 15, 20 and 30 | 2020-08-27 |
Triclabendazole |
Tablet | II (Paddle) | 75 | 0.1N HCl with 1% Tween 20 | 1000 | 5, 10, 15, 20 and 30 | 2020-08-27 |
Dapagliflozin/Saxagliptin HCl |
Tablet | | | Refer to FDA's Dissolution Guidance, 2018 | | | 2020-08-27 |
Gilteritinib Fumarate |
Tablet | II (Paddle) | 50 | 0.1 N HCl | 900 | 10, 15, 20, 30 and 45 | 2020-08-27 |
Monomethyl Fumarate |
Capsule (Delayed Release) | II (Paddle) Stationary Basket over the Paddle | 100 | Acid Stage: 0.1 N HCl; Buffer Stage: Phosphate buffer, pH 6.8 | | Acid Stage: 120; Buffer Stage: 15, 30, 45, 60, 90, 120 and 150 | 2020-08-27 |
Amoxicillin |
Capsule | | | Refer to FDA's Dissolution Guidance, 2018 | | | 2020-07-02 |
Alprazolam |
Tablet | | | Refer to FDA's Dissolution Guidance, 2018 | | | 2020-07-02 |
Alosetron HCl |
Tablet | | | Refer to FDA's Dissolution Guidance, 2018 | | | 2020-07-02 |
Anastrozole |
Tablet | | | Refer to FDA's Dissolution Guidance, 2018 | | | 2020-07-02 |
Aliskiren Hemifumarate |
Tablet | | | Refer to FDA's Dissolution Guidance, 2018 | | | 2020-07-02 |
Almotriptan Malate |
Tablet | | | Refer to FDA's Dissolution Guidance, 2018 | | | 2020-07-02 |
Acalabrutinib |
Capsule | | | Refer to FDA's Dissolution Guidance, 2018 | | | 2020-07-02 |
Albuterol Sulfate |
Tablet | | | Refer to FDA's Dissolution Guidance, 2018 | | | 2020-07-02 |
Acarbose |
Tablet | | | Refer to FDA's Dissolution Guidance, 2018 | | | 2020-07-02 |
Amlodipine Besylate |
Tablet | | | Refer to FDA's Dissolution Guidance, 2018 | | | 2020-07-02 |