Details for New Drug Application (NDA): 210302
✉ Email this page to a colleague
The generic ingredient in CANDESARTAN CILEXETIL 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 210302
Tradename: | CANDESARTAN CILEXETIL |
Applicant: | Alembic |
Ingredient: | candesartan cilexetil |
Patents: | 0 |
Pharmacology for NDA: 210302
Mechanism of Action | Angiotensin 2 Receptor Antagonists |
Suppliers and Packaging for NDA: 210302
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CANDESARTAN CILEXETIL | candesartan cilexetil | TABLET;ORAL | 210302 | ANDA | Alembic Pharmaceuticals Limited | 46708-341 | 46708-341-30 | 30 TABLET in 1 BOTTLE (46708-341-30) |
CANDESARTAN CILEXETIL | candesartan cilexetil | TABLET;ORAL | 210302 | ANDA | Alembic Pharmaceuticals Limited | 46708-341 | 46708-341-90 | 90 TABLET in 1 BOTTLE (46708-341-90) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 4MG | ||||
Approval Date: | Dec 4, 2018 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 8MG | ||||
Approval Date: | Dec 4, 2018 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 16MG | ||||
Approval Date: | Dec 4, 2018 | TE: | AB | RLD: | No |
Complete Access Available with Subscription