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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		 21-Oct 21-Nov 21-Dec 22-Jan 22-Feb 22-Mar 22-Apr 22-May 22-Jun 22-Jul 22-Aug 22-Sep FY-2022
Refuse to Receive (RTR) - Originals 3 3 3 3                 12
Standard - GDUFA II 3 2 1 1                 7
Priority - GDUFA II 0 1 2 2                 5
GDUFA I 0 0 0 0                 0
Acknowledgement - Original 61 63 45 83                 252
Refuse to Receive (RTR) - PAS 0 1 0 0                 1
Withdrawals (all original ANDAs) 201 5 31 17                 254
Approved ANDA 193 0 18 12                 223
Unapproved ANDA 8 5 13 5                 31
Withdrawals (PAS) 8 7 24 5                 44
Approvals 49 67 34 61                 211
First Time Generics 6 8 5 7                 26
Not First Time Generics 43 59 29 54                 185
First Cycle Approvals 12 13 4 17                 46
Not First Cycle Approvals 37 54 30 44                 165
Tentative Approvals 14 8 22 19                 63
First Cycle Tentative Approvals (included above) 2 0 2 1                 5
Complete Responses (CR) 152 168 108 195                 623
Information Requests (IR) 365 353 308 377                 1403
Originals 210 233 194 236                 873
Supplements 155 120 114 141                 530
Discipline Review Letters (DRL) 188 201 202 165                 756
Drug Master File Completeness Assessment (DMF CA) 57 73 38 42                 210

 

GDUFA YEAR (Receipts)
Submissions This Month		 21-Oct 21-Nov 21-Dec 22-Jan 22-Feb 22-Mar 22-Apr 22-May 22-Jun 22-Jul 22-Aug 22-Sep FY-2022
Abbreviated New Drug Applications (ANDA) + 24 51 135 61                 271
Amendments 220 188 236 200                 844
Major 95 77 101 68                 341
Minor 57 45 78 65                 245
Unsolicited Amendments ++ 68 66 57 67                 258
Pre-Submission Facility Correspondence 14 2 2 11                 29
CBE Supplements 811 753 821 643                 3028
PAS Supplements +++ 120 105 114 95                 434
DMFs - Type II 49 50 77 55                 231
Controls ++++ 322 332 252 318                 1224
Requests for Clarfication 1 2 3 4                 10
Post CR Meeting Requests This Month 5 3 5 3                 16

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.
+ = 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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