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Fuji
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Generated: February 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078702

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NDA 078702 describes CANDESARTAN CILEXETIL, which is a drug marketed by Alembic Pharms Ltd, Apotex Inc, Macleods Pharms Ltd, Sandoz, Zydus Pharms Usa Inc, Dr Reddys Labs Ltd, and Mylan Pharms Inc, and is included in ten NDAs. It is available from nine 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. Six suppliers are listed for this compound. Additional details are available on the candesartan cilexetil; hydrochlorothiazide profile page.
Summary for 078702
Tradename:CANDESARTAN CILEXETIL
Applicant:Sandoz
Ingredient:candesartan cilexetil
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 078702
Suppliers and Packaging for NDA: 078702
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CANDESARTAN CILEXETIL candesartan cilexetil TABLET;ORAL 078702 ANDA Sandoz Inc 0781-5936 N 0781-5936-31
CANDESARTAN CILEXETIL candesartan cilexetil TABLET;ORAL 078702 ANDA Sandoz Inc 0781-5937 N 0781-5937-31

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength4MG
Approval Date:May 3, 2013TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength8MG
Approval Date:May 3, 2013TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength16MG
Approval Date:May 3, 2013TE:ABRLD:No

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