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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 203813


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NDA 203813 describes CANDESARTAN CILEXETIL, which is a drug marketed by Alembic, Apotex, Macleods Pharms Ltd, Mylan, Prinston Inc, Zydus Lifesciences, Anda Repository, and Apotex Inc, and is included in thirteen NDAs. It is available from seven suppliers. Additional details are available on the CANDESARTAN CILEXETIL profile page.

The generic ingredient in CANDESARTAN CILEXETIL is candesartan cilexetil; hydrochlorothiazide. There are twenty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the candesartan cilexetil; hydrochlorothiazide profile page.
Summary for 203813
Tradename:CANDESARTAN CILEXETIL
Applicant:Macleods Pharms Ltd
Ingredient:candesartan cilexetil
Patents:0
Pharmacology for NDA: 203813
Mechanism of ActionAngiotensin 2 Receptor Antagonists
Suppliers and Packaging for NDA: 203813
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CANDESARTAN CILEXETIL candesartan cilexetil TABLET;ORAL 203813 ANDA Macleods Pharmaceuticals Limited 33342-114 33342-114-07 30 TABLET in 1 CONTAINER (33342-114-07)
CANDESARTAN CILEXETIL candesartan cilexetil TABLET;ORAL 203813 ANDA Macleods Pharmaceuticals Limited 33342-114 33342-114-10 90 TABLET in 1 CONTAINER (33342-114-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength4MG
Approval Date:Dec 5, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength8MG
Approval Date:Dec 5, 2016TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength16MG
Approval Date:Dec 5, 2016TE:ABRLD:No

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

 
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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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