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  4. How Drugs are Developed and Approved
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  6. Abbreviated New Drug Application (ANDA)
  7. Activities Report of the Generic Drug Program (FY 2018)
  1. Abbreviated New Drug Application (ANDA)

Activities Report of the Generic Drug Program (FY 2018)

GDUFA YEAR/Actions This Month 17-Oct 17-Nov 17-Dec 18-Jan 18-Feb 18-Mar 18-Apr 18-May 18-Jun 18-Jul 18-Aug 18-Sep FY-2018
Refuse to Receive (RTR) - Originals 10 30  18  11   9 9  5  11  5  7 4 127
Standard - GDUFA II 0 1  2  6   6 1  2  4  4  1  4 2 33
Priority - GDUFA II 0 5  5  3   3 6  3  4  7  3  3 2 44
GDUFA I 10 24  11  2   0 2  0  0  0  1  0 0 50
Acknowledgement - Original 66 161  63  51   105 86   57  136  72  70  84 103 1054
Refuse to Receive (RTR) - PAS 1 1  1  2   2 0  1  0  0  0  0 0 8
Withdrawals (all original ANDAs) 37 96  13  90   146 43  12  29  27  11  44 58 606
Approved ANDA 26 85  0  67   129 23  3  18  12  0  31 48 442
Unapproved ANDA 11 11  13  23   17 20  9  11  15  11  13 10 164
Withdrawals  (PAS) 5 5  9  4   11 10  8  6  0  7  9 7 81
 Approvals 87 84  78  25   32 57   66  67  74  96  53 62 781
First Cycle Approvals (included above)  26 13  20  11   7 7  13  7  11  16  6 5 142
Tentative Approvals 14 23  20  6   5 11   16  19  18  30  15 13 190
First Cycle Tentative Approvals (included above) 2 4  1  1   1 3  1  2  3  4  2 0 24
Complete Responses (CR) 325 240 242  307 185 159   142  185  217  357  156 133 2648
Information Requests (IR) 267 328 263  457  390 429  362  449  391  325  436 355 4452
Originals  185 231 190  360  297  321  280  344  283  217  323 261 3292
 Supplements  82  97  73  97  93  108  82  105  108  108  113 94 1160
Discipline Review Letters (DRL) 108 81 88  35   80 224  149  216  322  198  248 299 2048
Drug Master File Completeness Assessment (DMF CA) 50 59 48  64   47 89  49 48  45  49  53 58 659
GDUFA YEAR (Receipts)Submissions This Month 17-Oct 17-Nov 17-Dec 18-Jan 18-Feb 18-Mar 18-Apr 18-May 18-Jun 18-Jul 18-Aug 18-Sep FY-2018
Abbreviated New Drug Applications (ANDA) + 65 50  131  91   56 139  83  57  85  91  97 99 1044
ANDA Amendments 156 163  168  139   177 191  218  232  202  241  271 199 2357
Major 60 71  73  58   77 84  98  107  108  117  123 102 1078
Minor 88 90  94  80   100 105  115  124  92  120  146 96 1250
Unsolicited Amendments ** 8 2  1  1   0 2  5  1  2  4  2 1 29
Pre-Submission Facility Correspondence 5 1  5  8   9 6  5  6  1  6  7 8 67
CBE Supplements 580 657  475  453   496 361  651  574  675  512  575 479 6488
PAS Supplements 83 46  65  54   50 179  200  92  70  94  92 78 1103
DMFs - Type II 64 56  81  66   31 85  46  43  41  53  55 62 683
GDUFA YEAR (Receipts) 17-Oct 17-Nov 17-Dec 18-Jan 18-Feb 18-Mar 18-Apr 18-May 18-Jun 18-Jul 18-Aug 18-Sep FY-2018
Controls ++ 233 252  239  238   238 228  250  252  266  264  253 220 2933
Requests for Clarification 0 0  4  0   0 3  1  2  6  0  5 5 26
GDUFA Post CR Meeting Requests +++ 214 225  227  236   253 259  259  264  268  273  282 285  
Post CR Meeting Requests This month 8 11  2  9   17 6  0  5  4  5  9 3 79

NOTE: Numbers reflect current data at the time of posting and may change based on refreshed counts in our tracking systems, including application status updates.
These numbers are not intended for Congressional reporting purposes.

* = This data requires additional verification and will be posted when available. 
** = Unsolicited Amendments only include amendments submitted between review cycles.
+ = ANDA Original Receipts are reported as raw receipts (versus filed receipts).    
++ = Controls count only those requests deemed appropriate for a control.     
+++ = Cumulative and NOT specific to the month.     

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