| NDC Code: |
60505-3604 |
| Proprietary Name: |
Irbesartan and Hydrochlorothiazide |
| Suffix: |
|
| Non-Proprietary Name: |
Irbesartan and Hydrochlorothiazide |
| Dosage Form: |
TABLET, FILM COATED |
| Method: |
ORAL |
| Original Marketing Date: |
16-10-2012 |
| Category Name: |
ANDA |
| Application Number: |
ANDA201505 |
| Labeler: |
APOTEX CORP. |
| Substance Name: |
HYDROCHLOROTHIAZIDE; IRBESARTAN |
| Active Numerator Strength: |
12.5; 300 |
| Active Ingredient Unit: |
mg/1; mg/1 |
| Pharm Classes: |
Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] |
| DEA Schedule: |
|
