Details for New Drug Application (NDA): 203466
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The generic ingredient in CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE is candesartan cilexetil; hydrochlorothiazide. There are twenty-two drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the candesartan cilexetil; hydrochlorothiazide profile page.
Summary for 203466
Tradename: | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE |
Applicant: | Zydus Lifesciences |
Ingredient: | candesartan cilexetil; hydrochlorothiazide |
Patents: | 0 |
Pharmacology for NDA: 203466
Mechanism of Action | Angiotensin 2 Receptor Antagonists |
Physiological Effect | Increased Diuresis |
Suppliers and Packaging for NDA: 203466
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | candesartan cilexetil; hydrochlorothiazide | TABLET;ORAL | 203466 | ANDA | Zydus Pharmaceuticals USA Inc. | 68382-194 | 68382-194-01 | 100 TABLET in 1 BOTTLE (68382-194-01) |
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | candesartan cilexetil; hydrochlorothiazide | TABLET;ORAL | 203466 | ANDA | Zydus Pharmaceuticals USA Inc. | 68382-194 | 68382-194-06 | 30 TABLET in 1 BOTTLE (68382-194-06) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 16MG;12.5MG | ||||
Approval Date: | Nov 27, 2017 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 32MG;12.5MG | ||||
Approval Date: | Nov 27, 2017 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 32MG;25MG | ||||
Approval Date: | Nov 27, 2017 | TE: | AB | RLD: | No |
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