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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 7 20 12    
Withdrawals1975 13 7 11 8 4 17    
Approvals204030 34 34 38 41 20 44    
Tentative Approvals41012 5 7 7 7 9 10    
Complete Responses (CR)113126111 114 118 112 100 120 90    
              
Drug Master File Complete Assessment (DMF CA)18115098 192 129 130 105 156 173    
              
Submissions This Month             
Abbreviated New Drug Applications (ANDA)4158225 85 76 112 74 134 635    
              
Amendments - Originals176156143 139 131 160 155 153 115    
To Backlog ANDAs152123114 117 109 128 122 111 67    
To Cohort Yr 1 ANDAs222725 18 15 26 22 22 17    
To Cohort Yr 2 ANDAs264 4 7 6 11 20 31    
Amendments - Supplements216188266 264 192 241 264 225 212    
To Backlog Prior Approval Supplements (PAS)282126 59 35 37 44 29 35    
To Cohort Yr 1 PASs15102 10 3 9 18 19 11    
To Cohort Yr 2 PASs271838 28 33 39 36 37 33    
              
Tier Amendments000 0 0 0 0 0 0    
Tier 1A000 0 0 0 0 0 0    
Tier 1B000 0 0 0 0 0 0    
Tier 1C000 0 0 0 0 0 0    
Tier 2000 0 0 0 0 0 0    
Drug Master Files (DMF)6475102 83 69 131 92 78 103    
Controls819060 108 76 112 94 66 99    
              
GDUFA Post CR Meeting Requests  *252835 40 47 50 52 56 64    
STATUSNumber            
Canceled 223 3 3 3 3 3 3    
Complete 141517 22 26 30 35 38 43    
Denied  223 3 3 4 5 5 5    
Granted  014 3 3 3 2 2 5    
Pending  788 9 10 8 7 8 8    
              
Post CR Meeting Requests This month63836443    

 

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

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