Details for New Drug Application (NDA): 090704
✉ Email this page to a colleague
The generic ingredient in CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE is candesartan cilexetil; hydrochlorothiazide. There are twenty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the candesartan cilexetil; hydrochlorothiazide profile page.
Summary for 090704
Tradename: | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE |
Applicant: | Mylan |
Ingredient: | candesartan cilexetil; hydrochlorothiazide |
Patents: | 0 |
Pharmacology for NDA: 090704
Mechanism of Action | Angiotensin 2 Receptor Antagonists |
Physiological Effect | Increased Diuresis |
Suppliers and Packaging for NDA: 090704
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | candesartan cilexetil; hydrochlorothiazide | TABLET;ORAL | 090704 | ANDA | Mylan Pharmaceuticals Inc. | 0378-3001 | 0378-3001-77 | 90 TABLET in 1 BOTTLE, PLASTIC (0378-3001-77) |
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | candesartan cilexetil; hydrochlorothiazide | TABLET;ORAL | 090704 | ANDA | Mylan Pharmaceuticals Inc. | 0378-3002 | 0378-3002-77 | 90 TABLET in 1 BOTTLE, PLASTIC (0378-3002-77) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 16MG;12.5MG | ||||
Approval Date: | Dec 4, 2012 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 32MG;12.5MG | ||||
Approval Date: | Dec 4, 2012 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 32MG;25MG | ||||
Approval Date: | Dec 4, 2012 | TE: | AB | RLD: | No |
Complete Access Available with Subscription