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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 *           28
Standard - GDUFA II 6  3 3 1  4  4 *           21
Priority - GDUFA II 1  1 1 0  2  2 *           7
GDUFA I 0  0 0 0  0  0 *           0
Acknowledgement - Original 54  90 66 69  86  95 *           460
Refuse to Receive (RTR) - PAS 0  0 1 1  0  0 *           2
Withdrawals  (all original ANDAs) 54  9 19 30  13  55 *           180
Approved ANDA 31  6 10 10  3  36 *           96
Unapproved ANDA 23  3 9 20  10  19 *           84
Withdrawals  (PAS) 9  2 3 4  11  8 *           37
Approvals ++++ 110  99 69 82  83  89 98           630
   First Cycle Approvals (included above) 24  11 10 17  12  11 *           85
Tentative Approvals ++++ 22  32 39 24  19  17 18           171
    First Cycle Tentative Approvals (included above) 5  6 2 4  2  2 *           21
Complete Responses (CR) 175  230 144 206  162  206 208           1331
Information Requests (IR) 372  364 290 357  303  396 *           2082
Originals 247  249 207 230  203  257 *           1393
Supplements 125  115 83 127  100  139 *           689
Discipline Review Letters (DRL) 180  254 243 275  247  287 *           1486
Drug Master File Completeness Assessment (DMF CA) 55  58 48 30  58  64 *           313
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           582
ANDA Amendments 225  187 199 180   204  196 *           1191
Major 134  97 90 76  90  86 *           573
Minor 90  88 101 101  110  107 *           597
Unsolicited Amendments ** 1  2 8 3  4  3 *           21
Pre-Submission Facility Correspondence 12  2 5 4  5  3 *           31
CBE Supplements  596  597 604 679  625  841 *           3942
PAS Supplements ++ 76  65 67 69  59  65 *           401
DMFs - Type II 74  44 63 39  49  84 *           353
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 *           1486
Requests for Clarification 4  3 2 8  4  2 *           23
Post CR Meeting Requests This month 5  17 8 6  7  5 *           48

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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