Updates on Bioequivalence (BE) Webpage (November 2017): Immediate Release Solid Oral Dosage Form
1. Additional Comparators Added to the Existing Comparator List
|
No |
Active Ingredient |
Additional Comparators |
Manufacturer |
|
1 |
Benzhexol |
Apo-Trihex Tablet 2mg (MAL19984756AZ) |
Apotex Inc, Canada |
2. Additional Manufacturing Site added to Existing Comparator List
|
No |
Active Ingredient |
Comparator List |
Product Name |
Additional Manufacturing Site |
|
1 |
Naltrexone Hydrochloride |
BE |
Revia Tablet 50mg |
Bristol-Myers Squibb Australia Pty Ltd., Australia Teva Canada Limited, Canada |
|
2 |
Drosperinone 3mg + Ethinylestradiol 0.02mg |
FDC |
Yaz Tablets |
Bayer Weimar GmbH und Co. KG, Germany |
3. Active pharmaceutical ingredient added to “Other considerations (List C)”
(i) Destromethorphan HBr + Phenylephedrine HCl + Paracetamol
(ii) Dextromethorphan HBr + Pseudoephedrine HCl + Paracetamol
