Details for New Drug Application (NDA): 209119
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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 209119
Tradename: | CANDESARTAN CILEXETIL |
Applicant: | Alembic |
Ingredient: | candesartan cilexetil |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 209119
Mechanism of Action | Angiotensin 2 Receptor Antagonists |
Suppliers and Packaging for NDA: 209119
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CANDESARTAN CILEXETIL | candesartan cilexetil | TABLET;ORAL | 209119 | ANDA | Alembic Pharmaceuticals Limited | 46708-060 | 46708-060-10 | 100 TABLET in 1 CARTON (46708-060-10) |
CANDESARTAN CILEXETIL | candesartan cilexetil | TABLET;ORAL | 209119 | ANDA | Alembic Pharmaceuticals Limited | 46708-060 | 46708-060-30 | 30 TABLET in 1 BOTTLE (46708-060-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 32MG | ||||
Approval Date: | Jun 20, 2017 | TE: | AB | RLD: | No |
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