| Amphetamine |
Suspension (Extended Release) | | | Develop a dissolution method | | | 2016-12-22 |
| Mebendazole ( 500 mg) |
Tablet (Chewable) | II (Paddle) | 75 | 1% Sodium Lauryl Sulfate (SLS) in 0.01 N HCl | 900 | 5, 10, 15,
30, 45 and 60 minutes | 2016-12-22 |
| Perampanel |
Suspension | II (Paddle) | 50 | 0.1 N HCl | 900 [890 mL 0.1 N HC | 5, 10, 15, 20 and 30 | 2016-12-22 |
| Canagliflozin (Can)/ Metformin HCl (Met) |
Tablet (Extended Release) | Met: I (Basket, 40 mesh): Can: | Met: 100: Can:100 | Met: Simulated Gastric Fluid [SGF] without enzyme, pH 1.2; Can: 0.1% (w/v) polysorbate 20 in 0.05 M sodium phosphate buffer pH 6.8 ( 50 mg); 0.2% (w/v) polysorbate 20 in 0.05 M sodium phosphate buffer pH 6.8 (150 mg) | Met: 900: Can: 900 | Met: 1, 2, 4, 6, 8 10 and 12 hours: Can: 10, 15, 20, 30, 45 and 60 minutes; | 2016-12-22 |
| Oxycodone HCl/ Naloxone HCl |
Tablet (Extended Release) | II (Paddle) | 50 | Simulated Gastric Fluid [SGF, pH 1.2] without enzyme | 900 | 0.25, 0.5, 1, 2, 4, 6, 8, 10 and 12 hours | 2016-12-22 |
| Naltrexone HCl / Oxycodone HCl |
Capsule (Extended Release) | | | Develop a dissolution method | | | 2016-12-22 |
| Simvastatin |
Suspension | II (Paddle) | 50 | Phosphate Buffer, pH 7.0, with 0.14% sodium dodecyl sulfate (SDS) | 900 | 10, 15, 20, 30 and 45 | 2016-12-22 |
| Azithromycin |
Tablet | | | Refer to USP | | | 2016-12-22 |
| Atropine Sulfate/ Diphenoxylate HCl |
Tablet | | | Develop dissolution method(s) to characterize the dissolution of both components | | | 2016-12-22 |
| Granisetron |
Injectable (Extended Release) | | | Develop a method to characterize in vitro release | | | 2016-12-22 |
| Aspirin/ Omeprazole |
Tablet (Delayed Release) | I (Basket) | 100 | Acid Stage: 0.1 N HCl (degassed); Buffer Stage: Phosphate Buffer, pH 6.8 (degassed) | Acid Stage: 900; Buf | Acid Stage:120; Buffer Stage:10, 20, 30, 45, 60 and 75 | 2016-12-22 |
| Colchicine |
Capsule | II (Paddle) | 75 | Deionized Water with 2% Sodium Lauryl Sulfate (SLS) | 500 | 5, 10, 15, 20 and 30 | 2016-12-22 |
| Azithromycin |
Capsule | | | Refer to USP | | | 2016-12-22 |
| Lorcaserin HCl |
Tablet | II (Paddle) | 50 | 0.1 N HCl (deaerated) | 900 | 5, 10, 15, 20 and 30 | 2016-12-22 |
| Nitisinone |
Suspension | II (Paddle) | 50 | pH 1.2 HCl Buffer (degassed) | 1000 | 10, 15, 20, 30 and 45 | 2016-12-22 |
| Dasabuvir Na/ Ombitasvir/Paritaprevir/Ritonavir |
Tablet (Extended Release) | III (Reciprocating Cylinder [4 | 25 dpm | 15 mM hexadecyltrimethylammonium bromide (CTAB) in 0.03M Sodium Phosphate Buffer, pH 6.8 | 250 | Ombitasvir/ Paritaprevir/ Ritonavir: 10, 15, 20, 30, 45, 60 and 90 minutes;Dasabuvir: 1, 2, 3, 6, 9, | 2016-10-20 |
| Carbidopa/Levodopa |
Suspension (Enteral) | II (Paddle) | 25 | 0.05 M Sodium Acetate Buffer, pH 4.5 | 500 | 5, 10, 15, 20, 30, 40 and 60 | 2016-10-20 |
| Calcifediol |
Capsule (Extended Release) | II (Paddle) with sinker | 75 | 0.5% SDS in 5 mM Sodium Dihydrogenphosphate Monohydrate, pH 6.8 | 500 | 1, 2, 4, 6, 8, 10 and 12 hours | 2016-10-20 |
| Empagliflozin/Metformin Hydrochloride |
Tablet | II (Paddle) | 50 | Phosphate Buffer, pH 6.8 (deaerated) | 900 | 5, 10, 15, 20 and 30 | 2016-10-20 |
| Eltrombopag Olamine |
Suspension | II (Paddle) | 50 | 50 mM potassium phosphate in water, pH 6.8 with 0.2% polysorbate 80 | 750 | 4, 8, 12, 15 and 20 | 2016-10-20 |
