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OPOD-P LIQUID methadone hydrochloride 5 mg/mL oral liquid bottle, Aspen Pharma Pty Ltd, CON-1088
Product name
OPOD-P LIQUID methadone hydrochloride 5 mg/mL oral liquid bottle
Sponsor name
Aspen Pharma Pty Ltd
Consent start
Consent no.
CON-1088
Duration
The consent is effective from 20 March 2023 until 17 March 2025.
Standard
USP Methadone Hydrochloride Oral Solution monograph: pH range. of United States Pharmacopoeia
Non-compliance with standard
The products do not meet the pH requirements specified in the Methadone
Hydrochloride Oral Solution monograph (United States Pharmacopoeia 2023) which
requires a pH range of 1.0 - 4.0.
Import, Supply, &/or Export
supply
Therapeutic product type
Prescription medicines