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  7. Generic Drugs Program Activities Report - Monthly Performance
  1. Abbreviated New Drug Application (ANDA)

Generic Drugs Program Activities Report - Monthly Performance

GDUFA YEAR/
Actions This Month		 20-Oct 20-Nov 20-Dec 21-Jan 21-Feb 21-Mar 21-Apr 21-May 21-Jun 21-Jul 21-Aug 21-Sep FY-2021
Refuse to Receive (RTR) - Originals 3 6 0 1 *               10
Standard - GDUFA II 2 5 0 0 *               7
Priority - GDUFA II 1 1 0 1 *               3
GDUFA I 0 0 0 0 *               0
Acknowledgement - Original 52 47 31 57 *               187
Refuse to Receive (RTR) - PAS 0 0 0 0 *               0
Withdrawals  (all original ANDAs) 7 36 9 23 *               75
Approved ANDA 2 21 0 12 *               35
Unapproved ANDA 5 15 9 11 *               40
Withdrawals  (PAS) 5 5 5 3 *               18
Approvals 78 55 63 62 72               330
First-Time Generics 9 3 7 5 16               40
Not First-Time Generics 69 52 56 57 56               290
   First Cycle Approvals 19 7 10 17 *               53
Not First Cycle Approvals 59 48 53 45 *               205
Tentative Approvals 15 21 22 8 7               73
    First Cycle Tentative Approvals 3 4 2 1 *               10
Complete Responses (CR) 167 171 154 157 183               832
Information Requests (IR) 359 334 370 307 *               1370
Originals 215 184 203 177 *               779
Supplements 144 150 167 130 *               591
Discipline Review Letters (DRL) 199 166 168 131 *               664
Drug Master File Completeness Assessment (DMF CA) 52 73 59 58 *               242
GDUFA YEAR (Receipts) Submissions
This Month		 20-Oct 20-Nov 20-Dec 21-Jan 21-Feb 21-Mar 21-Apr 21-May 21-Jun 21-Jul 21-Aug 21-Sep FY-2021
Abbreviated New Drug Applications (ANDA) + 20 40 124 36 50               270
ANDA Amendments 176 204 292 179 *               851
Major 77 88 152 91 *               408
Minor 51 81 79 45 *               256
       Unsolicited Amendments++ 48 35 61 43 *               187
Pre-Submission Facility Correspondence 12 3 3 6 *               24
CBE Supplements  958 961 787 611 *               3317
PAS Supplements ++ + 126 112 122 83 *               443
DMFs - Type II 34 63 90 25 *               212
GDUFA YEAR (Receipts) 20-Oct 20-Nov 20-Dec 21-Jan 21-Feb 21-Mar 21-Apr 21-May 21-Jun 21-Jul 21-Aug 21-Sep FY-2021
Controls ++++ 312 305 280 329 *               1226
Requests for Clarification 3 2 3 1 *               9
Post CR Meeting Requests This Month 8 5 2 3 *               18

 

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.
+ = ANDA Original Receipts are reported as raw receipts (versus filed receipts).
++= Due to system capabilities, counts for unsolicited amendments were previously based on amendments submitted after a tentative approval was issued. Starting in Oct. 2019 (FY 2020) the monthly metric report now captures all unsolicited amendments submitted to the agency.
+++ = PAS Supplements do not include REMS PAS supplements.
++++ = Controls count only those requests deemed appropriate for a control.         

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