Details for New Drug Application (NDA): 078702
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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 078702
Tradename: | CANDESARTAN CILEXETIL |
Applicant: | Mylan |
Ingredient: | candesartan cilexetil |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 078702
Mechanism of Action | Angiotensin 2 Receptor Antagonists |
Suppliers and Packaging for NDA: 078702
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CANDESARTAN CILEXETIL | candesartan cilexetil | TABLET;ORAL | 078702 | ANDA | Mylan Pharmaceuticals Inc. | 0378-3224 | 0378-3224-77 | 90 TABLET in 1 BOTTLE, PLASTIC (0378-3224-77) |
CANDESARTAN CILEXETIL | candesartan cilexetil | TABLET;ORAL | 078702 | ANDA | Mylan Pharmaceuticals Inc. | 0378-3224 | 0378-3224-93 | 30 TABLET in 1 BOTTLE, PLASTIC (0378-3224-93) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 4MG | ||||
Approval Date: | May 3, 2013 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 8MG | ||||
Approval Date: | May 3, 2013 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 16MG | ||||
Approval Date: | May 3, 2013 | TE: | AB | RLD: | No |
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