| Product NDC: | 60505-3547 |
| Proprietary Name: | IRBESARTAN |
| Non Proprietary Name: | IRBESARTAN |
| Active Ingredient(s): | 75 mg/1 & nbsp; IRBESARTAN |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET, FILM COATED |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 60505-3547 |
| Labeler Name: | Apotex Corp. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA200832 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20121016 |
| Package NDC: | 60505-3547-9 |
| Package Description: | 90 TABLET, FILM COATED in 1 BOTTLE (60505-3547-9) |
| NDC Code | 60505-3547-9 |
| Proprietary Name | IRBESARTAN |
| Package Description | 90 TABLET, FILM COATED in 1 BOTTLE (60505-3547-9) |
| Product NDC | 60505-3547 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | IRBESARTAN |
| Dosage Form Name | TABLET, FILM COATED |
| Route Name | ORAL |
| Start Marketing Date | 20121016 |
| Marketing Category Name | ANDA |
| Labeler Name | Apotex Corp. |
| Substance Name | IRBESARTAN |
| Strength Number | 75 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] |