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Generated: February 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202884

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NDA 202884 describes CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Apotex Inc, Dr Reddys Labs Ltd, Macleods Pharms Ltd, Mylan Pharms Inc, and Zydus Pharms Usa Inc, and is included in five NDAs. It is available from three 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. Six suppliers are listed for this compound. Additional details are available on the candesartan cilexetil; hydrochlorothiazide profile page.
Summary for 202884
Applicant:Apotex Inc
Ingredient:candesartan cilexetil; hydrochlorothiazide
Formulation / Manufacturing:see details
Pharmacology for NDA: 202884
Mechanism of ActionAngiotensin 2 Receptor Antagonists
Physiological EffectIncreased Diuresis
Suppliers and Packaging for NDA: 202884
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE candesartan cilexetil; hydrochlorothiazide TABLET;ORAL 202884 ANDA Apotex Corp. 60505-3758 N 60505-3758-5
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE candesartan cilexetil; hydrochlorothiazide TABLET;ORAL 202884 ANDA Apotex Corp. 60505-3758 N 60505-3758-9

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength16MG;12.5MG
Approval Date:Dec 4, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength32MG;12.5MG
Approval Date:Dec 4, 2012TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength32MG;25MG
Approval Date:Jun 3, 2013TE:ABRLD:No

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