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  6. Abbreviated New Drug Application (ANDA)
  7. Activities Report of the Generic Drugs Program (FY 2014)
  1. Abbreviated New Drug Application (ANDA)

Activities Report of the Generic Drugs Program (FY 2014)

Actions This Month Oct-13 Nov-13 Dec-13 Jan-14 Feb-14 Mar-14 Apr-14 May-14 Jun-14 Jul-14 Aug-14 Sep-14 FY-2014
Refuse to Receive (RTR) 30 10 16 16 14 8 7 20 12 9 10 21  173
Withdrawals 19 7 5 13 7 11 8 4 17 17 36 35  179
Approvals 20 40 30 34 34 38 41 20 44 18 45 45  409
Tentative Approvals 4 10 12 5 7 7 7 9 10 6 7 7  91
Complete Responses (CR) 113 126 111 114 118 112 100 120 90 87 88 75  1254
Drug Master File Complete Assessment (DMF CA) 181 150 98 192 129 130 105 156 173 160 130 102  1706

 

Submissions This Month Oct-13 Nov-13 Dec-13 Jan-14 Feb-14 Mar-14 Apr-14 May-14 Jun-14 Jul-14 Aug-14 Sep-14 FY-2014
Abbreviated New Drug Applications (ANDA) 41 58 225 85 76 112 74 134 635 4 4 25  1473
Amendments - Originals 176 156 143 139 131 160 155 153 115 134 152 164  1778
To Backlog ANDAs 152 123 114 117 109 128 122 111 67 97 102 115  1357
To Cohort Yr 1 ANDAs 22 27 25 18 15 26 22 22 17 13 17 18  242
To Cohort Yr 2 ANDAs 2 6 4 4 7 6 11 20 31 24 32 31  179
Amendments - Supplements 216 188 266 264 192 241 264 225 212 297 298 225  2888
To Backlog Prior Approval Supplements (PAS) 28 21 26 59 35 37 44 29 35 37 44 24  419
To Cohort Yr 1 PASs 15 10 2 10 3 9 18 19 11 20 16 9  142
To Cohort Yr 2 PASs 27 18 38 28 33 39 36 37 33 41 44 44  418
Tier Amendments 0 0 0 0 0 0 0 0 0 0 0 0  0
Tier 1A 0 0 0 0 0 0 0 0 0 0 0 0  0
Tier 1B 0 0 0 0 0 0 0 0 0 0 0 0  0
Tier 1C 0 0 0 0 0 0 0 0 0 0 0 0  0
Tier 2 0 0 0 0 0 0 0 0 0 0 0 0  0
Drug Master Files (DMF) 64 75 102 83 69 131 92 78 103 80 74 88  1039
Controls 81 90 60 108 76 112 94 66 99 112 101 109  1087
GDUFA Post CR Meeting Requests * 29 36 46 49 54 58 63 66 74 77 80 85  

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Status Number Oct-13 Nov-13 Dec-13 Jan-14 Feb-14 Mar-14 Apr-14 May-14 Jun-14 Jul-14 Aug-14 Sep-14 FY-2014
Canceled 2 2 3 3 3 3 3 3 3 3 3 3  36
Complete 14 15 17 22 27 30 35 38 43 50 58 60  504
Denied 2 2 3 3 3 4 5 5 5 5 8 8  73
Granted 0 1 4 3 3 3 2 2 5 1 3 3  14
Pending 7 8 8 9 10 8 7 8 8 8 8 11 90
Post CR Meeting Requests This month 6 7 10 3 5 4 5 3 8 3 3 5  62
* = Cumulative and NOT specific to the month
Numbers are rounded and do not reflect actual numbers for Congressional reporting purposes
 

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