| NDC Code: |
0955-1046 |
| Proprietary Name: |
Irbesartan and Hydrochlorothiazide |
| Suffix: |
|
| Non-Proprietary Name: |
Irbesartan and Hydrochlorothiazide |
| Dosage Form: |
TABLET, FILM COATED |
| Method: |
ORAL |
| Original Marketing Date: |
01-03-2012 |
| End of Marketing: |
31-12-2062 |
| Category Name: |
NDA |
| Application Number: |
NDA020758 |
| Labeler: |
WINTHROP U.S. |
| 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: |
|
