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Last Updated: June 4, 2020

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Details for New Drug Application (NDA): 203813


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NDA 203813 describes CANDESARTAN CILEXETIL, which is a drug marketed by Alembic Pharms Ltd, Apotex Inc, Macleods Pharms Ltd, Mylan, Zydus Pharms, Dr Reddys Labs Ltd, and Prinston Inc, and is included in twelve NDAs. It is available from eight 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. Nine 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 203813
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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