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candesartan cilexetil/hydrochlorothiazide (CANDESARTAN HCTZ GPPL) 16 mg/12.5 mg tablet bottle, Generic Partners Pty Ltd, CON-170
Product name
candesartan cilexetil/hydrochlorothiazide (CANDESARTAN HCTZ GPPL) 16 mg/12.5 mg tablet bottle
Sponsor name
Generic Partners Pty Ltd
ARTG
253495
Consent start
Consent no.
CON-170
Standard
The products 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