Drugs

Activities Report of the Generic Drug Program (FY 2015)

 

GDUFA YEAR/
Actions This Month
Oct-14Nov-14Dec-14Jan-15Feb-15Mar-15Apr-15May-15Jun-15Jul-15Aug-15Sep-15FY-2015
Refuse to Receive (RTR)63 18          
Withdrawals612 2          
Approvals4528 29          
Tentative Approvals107 5          
Complete Responses (CR)4376 95          
Drug Master File Complete Assessment (DMF CA)12455 71          

 

GDUFA YEAR/
Submissions This Month
Oct-14Nov-14Dec-14Jan-15Feb-15Mar-15Apr-15May-15Jun-15Jul-15Aug-15Sep-15FY-2015
Abbreviated New Drug Applications (ANDA)4923 43          
Amendments - Originals** *          
To Backlog ANDAs** *          
To Cohort Yr 1 ANDAs** *          
To Cohort Yr 2 ANDAs** *          
Amendments - Supplements** *          
To Backlog Prior Approval Supplements (PAS)** *          
To Cohort Yr 1 PASs** *          
To Cohort Yr 2 PASs** *          
Tier Amendments** *          
Tier 1A** *          
Tier 1B** *          
Tier 1C** *          
Tier 2** *          
Drug Master Files (DMF)9571 88          
Controls159128 141          
GDUFA Post CR Meeting Requests +8489 96          

 

GDUFA YEAR/

Status

Oct-14Nov-14Dec-14Jan-15Feb-15Mar-15Apr-15May-15Jun-15Jul-15Aug-15Sep-15FY-2015
Canceled** *          
Complete** *          
Denied** *          
Granted** *          
Pending** *          
Post CR Meeting Requests This month05 7          

* Currently under reconciliation between data systems

+ = Cumulative and NOT specific to the month
Numbers are rounded and do not reflect actual numbers for Congressional reporting purposes
 
 

Return to Generic Drugs: Information for Industry 

 

Page Last Updated: 01/26/2015
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.