NDC Code: |
60505-3603 |
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; 150 |
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: |
|