Application 090201
- Type
- ANDA
- Sponsor
- HIKMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | IRBESARTAN | IRBESARTAN | TABLET;ORAL | 75MG | No | No |
| 002 | IRBESARTAN | IRBESARTAN | TABLET;ORAL | 150MG | No | No |
| 003 | IRBESARTAN | IRBESARTAN | TABLET;ORAL | 300MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0054-0250 | Irbesartan | Irbesartan | West-Ward Pharmaceuticals Corp. | ANDA | Current |
| 0054-0251 | Irbesartan | Irbesartan | West-Ward Pharmaceuticals Corp. | ANDA | Current |
| 0054-0252 | Irbesartan | Irbesartan | West-Ward Pharmaceuticals Corp. | ANDA | Current |