Application 203813
- Type
- ANDA
- Sponsor
- MACLEODS PHARMS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | TABLET;ORAL | 4MG | No | No |
| 002 | CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | TABLET;ORAL | 8MG | No | No |
| 003 | CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | TABLET;ORAL | 16MG | No | No |
| 004 | CANDESARTAN CILEXETIL | CANDESARTAN CILEXETIL | TABLET;ORAL | 32MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0904-7034 | Candesartan | Candesartan | Major Pharmaceuticals | ANDA | Current |
| 0904-7034 | Candesartan | Candesartan | Major Pharmaceuticals | ANDA | Current |
| 33342-114 | Candesartan | Candesartan | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-114 | Candesartan | Candesartan | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-114 | Candesartan | Candesartan | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-115 | Candesartan | Candesartan | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-115 | Candesartan | Candesartan | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-115 | Candesartan | Candesartan | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-116 | Candesartan | Candesartan | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-116 | Candesartan | Candesartan | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-116 | Candesartan | Candesartan | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-117 | Candesartan | Candesartan | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-117 | Candesartan | Candesartan | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-117 | Candesartan | Candesartan | Macleods Pharmaceuticals Limited | ANDA | Current |