Details for New Drug Application (NDA): 203466
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NDA 203466 describes CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Apotex Inc, Dr Reddys Labs Ltd, Macleods Pharms Ltd, Mylan, Prinston Inc, and Zydus Lifesciences, and is included in six NDAs. It is available from four suppliers. Additional details are available on the CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE profile page.
The generic ingredient in CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE 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.
The generic ingredient in CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE 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 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 Lifesciences Limited | 70771-1325 | 70771-1325-0 | 1000 TABLET in 1 BOTTLE (70771-1325-0) |
| CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | candesartan cilexetil; hydrochlorothiazide | TABLET;ORAL | 203466 | ANDA | Zydus Lifesciences Limited | 70771-1325 | 70771-1325-1 | 100 TABLET in 1 BOTTLE (70771-1325-1) |
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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