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Last Updated: August 9, 2020

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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 Pharms, and is included in six NDAs. It is available from five 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. Nine suppliers are listed for this compound. Additional details are available on the candesartan cilexetil; hydrochlorothiazide profile page.
Pharmacology for NDA: 203466
Mechanism of ActionAngiotensin 2 Receptor Antagonists
Physiological EffectIncreased 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 Pharmaceuticals (USA) Inc. 68382-194 68382-194-01 100 TABLET in 1 BOTTLE (68382-194-01)
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE candesartan cilexetil; hydrochlorothiazide TABLET;ORAL 203466 ANDA Zydus Pharmaceuticals (USA) Inc. 68382-194 68382-194-06 30 TABLET in 1 BOTTLE (68382-194-06)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength16MG;12.5MG
Approval Date:Nov 27, 2017TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength32MG;12.5MG
Approval Date:Nov 27, 2017TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength32MG;25MG
Approval Date:Nov 27, 2017TE:ABRLD:No

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