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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, Macleods Pharms Ltd, and Mylan Labs, and is included in eight NDAs. There is one patent 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. Eight 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 / Packaging: see list28
Therapeutic Class:Cardiovascular Agents

Pharmacology for Ingredient: candesartan cilexetil

Tentative approvals for CANDESARTAN CILEXETIL

Applicant Application No. Form Dosage
<disabled><disabled>TABLET; ORAL4MG
<disabled><disabled>TABLET; ORAL8MG
<disabled><disabled>TABLET; ORAL16MG

Clinical Trials for: candesartan cilexetil

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

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

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

ARIA (Atacand Renoprotection In NephropAthy Pt.)
Status: Completed Condition: Non-diabetic Nephropathy With Hypertension

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

Relative Bioavailability Study of Candesartan Cilexetil Under Fasting Conditions
Status: Completed Condition: Respiratory Disorders

Courtesy of
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
candesartan cilexetil; hydrochlorothiazide
TABLET;ORAL021093-001Sep 5, 2000RXNo5,721,263<disabled>Y <disabled>
Macleods Pharms Ltd
candesartan cilexetil; hydrochlorothiazide
TABLET;ORAL204100-002Feb 27, 2015RXNo<disabled><disabled>
candesartan cilexetil
TABLET;ORAL078702-004May 3, 2013RXNo<disabled><disabled>
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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