Details for New Drug Application (NDA): 091390
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The generic ingredient in CANDESARTAN CILEXETIL 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 091390
Tradename: | CANDESARTAN CILEXETIL |
Applicant: | Zydus Lifesciences |
Ingredient: | candesartan cilexetil |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 091390
Mechanism of Action | Angiotensin 2 Receptor Antagonists |
Suppliers and Packaging for NDA: 091390
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CANDESARTAN CILEXETIL | candesartan cilexetil | TABLET;ORAL | 091390 | ANDA | Zydus Pharmaceuticals USA Inc. | 68382-190 | 68382-190-05 | 500 TABLET in 1 BOTTLE (68382-190-05) |
CANDESARTAN CILEXETIL | candesartan cilexetil | TABLET;ORAL | 091390 | ANDA | Zydus Pharmaceuticals USA Inc. | 68382-190 | 68382-190-06 | 30 TABLET in 1 BOTTLE (68382-190-06) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 4MG | ||||
Approval Date: | Aug 23, 2017 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 8MG | ||||
Approval Date: | Aug 23, 2017 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 16MG | ||||
Approval Date: | Aug 23, 2017 | TE: | AB | RLD: | No |
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