Application 206194
- Type
- ANDA
- Sponsor
- HISUN PHARM HANGZHOU
Application Products#
Product, Drug, Ingredient table| 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 table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 42658-121 | IRBESARTAN | IRBESARTAN | Hisun Pharmaceuticals USA Inc. | ANDA | Current |
| 42658-121 | IRBESARTAN | IRBESARTAN | Hisun Pharmaceuticals USA Inc. | ANDA | Current |
| 42658-121 | IRBESARTAN | IRBESARTAN | Hisun Pharmaceuticals USA Inc. | ANDA | Current |
| 42658-121 | IRBESARTAN | IRBESARTAN | Hisun Pharmaceuticals USA Inc. | ANDA | Current |
| 42658-122 | IRBESARTAN | IRBESARTAN | Hisun Pharmaceuticals USA Inc. | ANDA | Current |
| 42658-122 | IRBESARTAN | IRBESARTAN | Hisun Pharmaceuticals USA Inc. | ANDA | Current |
| 42658-122 | IRBESARTAN | IRBESARTAN | Hisun Pharmaceuticals USA Inc. | ANDA | Current |
| 42658-122 | IRBESARTAN | IRBESARTAN | Hisun Pharmaceuticals USA Inc. | ANDA | Current |
| 42658-123 | IRBESARTAN | IRBESARTAN | Hisun Pharmaceuticals USA Inc. | ANDA | Current |
| 42658-123 | IRBESARTAN | IRBESARTAN | Hisun Pharmaceuticals USA Inc. | ANDA | Current |
| 42658-123 | IRBESARTAN | IRBESARTAN | Hisun Pharmaceuticals USA Inc. | ANDA | Current |
| 42658-123 | IRBESARTAN | IRBESARTAN | Hisun Pharmaceuticals USA Inc. | ANDA | Current |
| 50090-4519 | IRBESARTAN | IRBESARTAN | A-S Medication Solutions | ANDA | Current |