candesartan cilexetil/hydrochlorothiazide (CANDESAN COMBI 16/12.5) 16 mg/12.5 mg tablet blister pack, Arrow Pharma Pty Ltd, CON-172
Product name
candesartan cilexetil/hydrochlorothiazide (CANDESAN COMBI 16/12.5) 16 mg/12.5 mg tablet blister pack
Sponsor name
Arrow Pharma Pty Ltd
Consent start
Consent no.
CON-172
Standard
The products that do not conform to the requirements of the individual USP monograph Candesartan Cilexetil and Hydrochlorothiazide Tablets (the default standard for the product).
Non-compliance with standard
The candesartan impurity E content exceeds the USP monograph requirement of NMT
0.2%.
Conditions imposed
The candesartan impurity E expiry limit in drug product is the same as that
currently approved (NMT 0.5%).
Therapeutic product type
Prescription medicines