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U.S. Department of Health and Human Services

Drugs

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Activities Report of the Generic Drug Program (FY 2014)

GDUFA Year Oct-13Nov-13Dec-13Jan-14Feb-14Mar-14Apr-14May-14Jun-14Jul-14Aug-14Sep-14Total Yr 2
Actions This Month             
Refuse to Receive (RTR)301016 16 14 8       
Withdrawals1975 13 7 11       
Approvals204030 34 34 38       
Tentative Approvals41012 5 7 7       
Complete Responses (CR)113126111 114 118 112       
              
Drug Master File Complete Assessment (DMF CA)18115098 192 129 130       
              
Submissions This Month             
Abbreviated New Drug Applications (ANDA)4158225 85 76 112       
              
Amendments - Originals176156143 139 131 160       
To Backlog ANDAs152123114 117 109 128       
To Cohort Yr 1 ANDAs222725 18 15 26       
To Cohort Yr 2 ANDAs264 4 7 6       
Amendments - Supplements216188266 264 192 241       
To Backlog Prior Approval Supplements (PAS)282126 59 35 37       
To Cohort Yr 1 PASs15102 10 3 9       
To Cohort Yr 2 PASs271838 28 33 39       
              
Tier Amendments000 0 0 0       
Tier 1A000 0 0 0       
Tier 1B000 0 0 0       
Tier 1C000 0 0 0       
Tier 2000 0 0 0       
Drug Master Files (DMF)6475102 83 69 131       
Controls819060 108 76 112       
              
GDUFA Post CR Meeting Requests  *252835 40 45 48       
STATUSNumber            
Canceled 223 3 3 3       
Complete 141517 22 26 30       
Denied  223 3 3 4       
Granted  014 3 3 3       
Pending  788 9 10 8       
              
Post CR Meeting Requests This month324 2 5 2       

 

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

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