Establish Therapeutic Equivalence Requirements for Any Generic or Following- on Drug Product Referencing Adderall XR MASP-CLOSED
concentration-time curve xr masp disorder hyperactivity 5mg 10mg 15mg 20mg 25mg 30mg amphetamine single-entity salt ADDERALL ANDA application abbreviated drug new CDER-CLOSED
2012-04-12 2012-04-12 2012-04-12 2012-04-12
FDA-2005-P-0120-0023 FDA-2005-P-0120-0021 FDA-2005-P-0120-0020 FDA-2005-P-0120-0022
04:00:00 04:00:00 04:00:00 04:00:00
https://api.regulations.gov/v4/comments/FDA-2005-P-0120-0023 https://api.regulations.gov/v4/comments/FDA-2005-P-0120-0021 https://api.regulations.gov/v4/comments/FDA-2005-P-0120-0020 https://api.regulations.gov/v4/comments/FDA-2005-P-0120-0022
Anonymous Anonymous Anonymous Anonymous
Anonymous Anonymous Anonymous Anonymous
na na na na