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  7. Activities Report of the Generic Drugs Program (FY 2019) Monthly Performance
  1. Types of Applications

Activities Report of the Generic Drugs Program (FY 2019) Monthly Performance

Activities Report of the Generic Drugs Program (FY 2019) Monthly Performance

GDUFA YEAR/Actions This Month 18-Oct 18-Nov 18-Dec 19-Jan 19-Feb 19-Mar 19-Apr 19-May 19-Jun 19-Jul 19-Aug 19-Sep FY-2019
Refuse to Receive (RTR) - Originals 7  4 4  6  6 6 3 *       37
Standard - GDUFA II 6  3 3 1  4  4 5 3 *       29
Priority - GDUFA II 1  1 1 0  2  2 1 0 *       8
GDUFA I 0  0 0 0  0  0 0 0 *       0
Acknowledgement - Original 54  90 66 69  86  95 82 103 *       645
Refuse to Receive (RTR) - PAS 0  0 1 1  0  0 0 0 *       2
Withdrawals  (all original ANDAs) 54  9 19 30  13  55 9 63 *       252
Approved ANDA 31  6 10 10  3  36 0 31 *       127
Unapproved ANDA 23  3 9 20  10  19 9 32 *       125
Withdrawals  (PAS) 9  2 3 4  11  8 4 7 *       48
Approvals ++++ 110  99 69 82  83  89 93 83 45       753
   First Cycle Approvals (included above) 24  11 10 17  12  11 10 10 *       105
Tentative Approvals ++++ 22  32 39 24  19  17 18 12 17       200
    First Cycle Tentative Approvals (included above) 5  6 2 4  2  2 2 1 *       24
Complete Responses (CR) 175  230 144 206  162  206 208 235 180       1746
Information Requests (IR) 372  364 290 357  303  396 389 385 *       2856
Originals 247  249 207 230  203  257 253 268 *       1914
Supplements 125  115 83 127  100  139 136 117 *       942
Discipline Review Letters (DRL) 180  254 243 275  247  287 233 247 *       1966
Drug Master File Completeness Assessment (DMF CA) 55  58 48 30  58  64 68 71 *       452
GDUFA YEAR (Receipts)
Submissions This Month
18-Oct 18-Nov 18-Dec 19-Jan 19-Feb 19-Mar 19-Apr 19-May 19-Jun 19-Jul 19-Aug 19-Sep FY-2019
Abbreviated New Drug Applications (ANDA) + 83  54 107 74  76  118 70 66 48       696
ANDA Amendments 225  187 199 180   204  196 200 192 *       1583
Major 134  97 90 76  90  86 109 110 *       792
Minor 90  88 101 101  110  107 87 78 *       762
Unsolicited Amendments ** 1  2 8 3  4  3 4 4 *       29
Pre-Submission Facility Correspondence 12  2 5 4  5  3 3 4 *       38
CBE Supplements  596  597 604 679  625  841 785 819 *       5546
PAS Supplements ++ 76  65 67 69  59  65 85 70 *       556
DMFs - Type II 74  44 63 39  49  84 56 45 *       454
GDUFA YEAR (Receipts) 18-Oct 18-Nov 18-Dec 19-Jan 19-Feb 19-Mar 19-Apr 19-May 19-Jun 19-Jul 19-Aug 19-Sep FY-2019
Controls +++ 240  246 249 264  252  235 291 267 *       2044
Requests for Clarification 4  3 2 8  4  2 4 1 *       28
Post CR Meeting Requests This month 5  17 8 6  7  5 5 10 *       63

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).
++ = PAS Supplements do not include REMS PAS supplements.
+++ = Controls count only those requests deemed appropriate for a control.

++++ = FY19 Approval and Tentative Approval counts were updated in April 2019 to better reflect program output by capturing all approval actions on original applications, including split approvals (final approvals of certain strengths in an ANDA at the same time that certain other strengths are tentatively approved) and subsequent tentative approvals of applications that have previously been tentatively approved.         
 

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