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Generated: December 14, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090704

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NDA 090704 describes CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Apotex Inc, Dr Reddys Labs Ltd, Macleods Pharms Ltd, and Mylan Pharms Inc, and is included in four 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 090704

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 090704

Ingredient-typeThiazides
Mechanism of ActionAngiotensin 2 Receptor Antagonists
Physiological EffectIncreased Diuresis

Suppliers and Packaging for NDA: 090704

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE candesartan cilexetil; hydrochlorothiazide TABLET;ORAL 090704 ANDA Mylan Pharmaceuticals Inc. 0378-3001 0378-3001-05 500 TABLET in 1 BOTTLE, PLASTIC (0378-3001-05)
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE candesartan cilexetil; hydrochlorothiazide TABLET;ORAL 090704 ANDA Mylan Pharmaceuticals Inc. 0378-3001 0378-3001-77 90 TABLET in 1 BOTTLE, PLASTIC (0378-3001-77)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength32MG;25MG
Approval Date:Dec 4, 2012TE:ABRLD:No


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