Drug Master Files (DMF) are commonly used in the US and Canadian regulatory processes for describing the manufacture of both active and non-active components. Therefore, DMFs for ZEPHEX®134a have been filed with and reviewed by the US Food and Drug Administration and the Canadian Therapeutic Products Program. A DMF for ZEPHEX®227ea has also been filed with the US FDA.
ZEPHEX®134a
To request a Letter of Access to US DMF 13067 click
here
To request a Letter of Access to Canadian DMF 9853 click
here
ZEPHEX®227ea
To request a Letter of Access to US DMF 15801 click
here