| Product |
USDMF Number |
EDMF Number |
CEP Number |
CDMF |
Europe Regulatory Procedures |
| Alfuzosin Hydrochloride |
20867 |
 |
CEP 2006-208 / Granted |
|
|
| Aprepitant |
Q4 – 2009 |
|
|
|
|
| Atorvastatin Calcium (Amorphous) |
22785 |
|
|
|
|
| Atorvastatin Calcium (Form-1) |
21892 |
|
|
|
|
| Bosentan |
23255 |
|
|
|
|
| Carbinoxamine Maleate |
21301 |
|
|
|
|
| Clopidogrel Besylate |
|
|
|
|
DCP & NA |
| Clopidogrel Bisulfate (Form-1) |
21309 |
|
|
2009-223 |
NA |
| Darifenacin Hydrobromide |
22225 |
|
|
|
|
| Duloxetine Hydrochloride |
20996 |
|
|
|
|
| Dutasteride |
23533 |
|
|
|
|
| Eplerenone |
23466 |
|
|
|
|
| Ezetimibe |
21554 |
|
|
|
DCP |
| Finasteride |
|
|
CEP 2008-024 / Granted |
|
NA & MRP |
| Finasteride USP |
21276 |
|
|
|
|
| Ketorolac Trometamol |
: |
|
CEP 2008-144 / Granted |
|
|
| Ketorolac Tromethamine USP |
21693 |
|
|
|
|
| Memantine Hydrochloride |
22112 |
|
CEP 2008-144 |
|
|
| Montelukast Sodium [MT] |
20580 |
|
|
|
DCP & NA |
| Montelukast Sodium [MB] |
22484 |
|
|
2008-142 |
DCP & NA |
| Moxifloxacin |
|
|
|
|
|
| Moxifloxacin HCl [Monohydrate] |
20755 |
|
CEP 2007-355 / Granted |
|
|
| Olmesartan Medoxomil |
Q1 – 2010 |
|
|
|
|
| Paliperidone |
Q1 – 2010 |
|
|
|
|
| Pantoprazole Sodium |
20850 |
|
|
|
|
| Pitavastatin Calcium |
23488 |
|
|
|
|
| Pregabalin |
22111 |
|
|
2009-030 |
|
| Ranolazine |
22350 |
|
|
|
|
| Rosuvastatin Calcium [RV] |
20712 |
|
|
2008-008 |
DCP & NA |
| Rosuvastatin Calcium [RT] |
|
|
|
2009-040 |
DCP & NA |
| Solifenacin succinate |
Q1 – 2010 |
|
|
|
|
| Sumatriptan Succinate |
22482 |
|
CEP 2009-096 |
|
|
| Sumatriptan Base |
23442 |
|
|
|
|
| Telmisartan |
22731 |
|
CEP 2009-108 |
|
|
| Terbinafine Hydrochloride |
20413 |
|
CEP 2006-157 / Granted |
|
NA |
| Voriconazole |
21523 |
|
|
2009-077 |
|
