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Details for Generic Name: candesartan cilexetil

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Candesartan cilexetil is the generic ingredient in four branded drugs marketed by Astrazeneca, Apotex Inc, Sandoz, Dr Reddys Labs Ltd, and Mylan Labs, and is included in seven NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are twenty-one drug master file entries for candesartan cilexetil. Six suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for Generic Name: candesartan cilexetil

Drug Master File Entries: see list21
Suppliers: see list6
Therapeutic Class:Cardiovascular Agents

Pharmacology for Ingredient: candesartan cilexetil

Tentative approvals for CANDESARTAN CILEXETIL

Applicant Application No. Form Dosage
<disabled><disabled>TABLET; ORAL8MG
<disabled><disabled>TABLET; ORAL16MG
<disabled><disabled>TABLET; ORAL32MG

Clinical Trials for: candesartan cilexetil

CKD-330 Drug-Drug Interaction Study (Candesartan)
Status: Completed Condition: Hypertension

Antihypertensive Efficacy and Safety of Candesartan/HCT 32/25 mg in Comparison With Individual Components and Placebo
Status: Completed Condition: Hypertension

Candesartan Effect in Second Stage Arterial Hypertension
Status: Completed Condition: Stage II Hypertension

Open-Label Long-Term Safety and Efficacy Study of Fixed Dose Combination of Nifedipine Gastrointestinal Therapeutic System and Candesartan Cilexetil in Subjects With Moderate to Severe Essential Hypertension
Status: Completed Condition: Hypertension

Pharmacokinetic Interactions of Candesartan Cilexetil and Amlodipine Besylate
Status: Active, not recruiting Condition: Healthy

Monotherapy-Controlled Study of Nifedipine Gastrointestinal Therapeutic System and Candesartan Cilexetil in Combination in Subjects With Essential Hypertension Inadequately Controlled on Candesartan Cilexetil
Status: Not yet recruiting Condition: Hypertension

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Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
candesartan cilexetil; hydrochlorothiazide
TABLET;ORAL021093May 16, 2008RXYes5,721,263<disabled>Y<disabled>
Apotex Inc
candesartan cilexetil; hydrochlorothiazide
TABLET;ORAL202884Dec 4, 2012RXNo<disabled><disabled>
candesartan cilexetil; hydrochlorothiazide
TABLET;ORAL021093May 16, 2008RXYes5,534,534*PED<disabled>Y<disabled>
candesartan cilexetil; hydrochlorothiazide
TABLET;ORAL021093Sep 5, 2000RXNo5,958,961<disabled>Y<disabled>
candesartan cilexetil
TABLET;ORAL078702May 3, 2013RXNo<disabled><disabled>
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