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  6. Abbreviated New Drug Application (ANDA)
  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 9 3 *           24
Standard - GDUFA II 3 2 1 1 8 3 *           18
Priority - GDUFA II 0 1 2 2 1 0 *           6
GDUFA I 0 0 0 0 0 0 *           0
Acknowledgement - Original 61 63 45 83 91 62 *           405
Refuse to Receive (RTR) - PAS 0 1 0 0 0 0 *           1
Withdrawals (all original ANDAs) 201 5 31 17 10 25 *           289
Approved ANDA 193 0 18 12 2 15 *           240
Unapproved ANDA 8 5 13 5 8 10 *           49
Withdrawals (PAS) 8 7 24 5 18 8 *           70
Approvals 49 67 34 61 59 63 45           378
First Time Generics 6 8 5 7 7 14 11           58
Not First Time Generics 43 59 29 54 52 49 34           320
First Cycle Approvals 12 13 4 17 8 10 *           64
Not First Cycle Approvals 37 54 30 44 51 53 *           269
Tentative Approvals 14 8 22 19 12 18 17           110
First Cycle Tentative Approvals (included above) 2 0 2 1 2 0 *           7
Complete Responses (CR) 152 168 108 195 141 141 168           1073
Information Requests (IR) 365 353 308 377 422 466 *           2291
Originals 210 233 194 236 260 284 *           1417
Supplements 155 120 114 141 162 182 *           874
Discipline Review Letters (DRL) 188 201 202 165 168 243 *           1167
Drug Master File Completeness Assessment (DMF CA) 57 73 38 42 44 58 *           312

 

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 50 125 64           510
Amendments 220 188 236 200 225 261 *           1330
Major 95 77 101 68 76 95 *           512
Minor 57 45 78 65 77 83 *           405
Unsolicited Amendments ++ 68 66 57 67 72 83 *           413
Pre-Submission Facility Correspondence 14 2 2 11 2 6 *           37
CBE Supplements 811 753 821 643 548 748 *           4324
PAS Supplements +++ 120 105 114 95 85 138 *           657
DMFs - Type II 49 50 77 55 58 82 *           371
Controls ++++ 322 332 252 318 341 347             1912
Requests for Clarfication 1 2 3 4 2 1             13
Post CR Meeting Requests This Month 5 3 5 3 4 4             24

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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